Selectra/Flexor
ALBUMIN IN URINE/CSF FS
TEST PARAMETERS
(Microalbumin)
Serum application
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Albumin Serum
AlbS
Two-point
578 nm
g/l
2
0.000 g/l
100.0 g/l
TruCal Protein
3
6
Multi*
Selectra 2 – Non Linear
Selectra XL – Standard Cubic Spline
14 days
No
0.010%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 g/l
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
AlbS
No
25 ml
300 µl
301 µl
2.0 µl
1.0 µl
5 ml
60 µl
60 µl
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 0242 .. .. …
Notes
1. Please refer to the package insert for Albumin in Urine/CSF
FS *Microalbumin for detailed information about the test on
the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 0242 90 32 51
September 2008/7
Selectra/Flexor
ALBUMIN IN URINE/CSF FS
TEST PARAMETERS
(Microalbumin)
Urine/CSF application
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
MIcroalbumin
MAU
Two-point
405 nm
mg/l
2
0.000 mg/l
300.0 mg/l
TruCal Alb U/CSF
3
6
Multi*
Selectra 2 – Non Linear
Selectra XL – Standard Cubic Spline
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/l
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
TRF
No
25 ml
250 µl
254 µl
12.0 µl
8.0 µl
5 ml
50 µl
50 µl
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 0242 .. .. …
Notes
1. Please refer to the package insert for Albumin in Urine/CSF
FS *Microalbumin for detailed information about the test on
the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 0242 90 52 51
September 2008/7
Selectra/Flexor
ALBUMIN FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Albumin
ALB
Endpoint
578 nm
g/l
I
0.000 g/l
70.000 g/l
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.00
0.000 g/l
DUAL MODE
Order information
Cat. No. 1 0220 .. .. …
Notes
1. Please refer to the package insert for Albumin FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Albumin
No
25 ml
300 µl
301 µl
3.0 µl
2.0 µl
5 ml
0 µl
0 µl
No
4.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Albumin
No
25 ml
300 µl
301 µl
3.0 µl
2.0 µl
11.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 0220 90 02 51
September 2008/7
Selectra/Flexor
ALAT (GPT) FS (IFCC Mod.)
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
ALAT
ALT
Kinetic
340 nm
U/l
I
0
500
None
-
Order information
Cat. No. 1 2701.. .. …
Notes
No
*
*
*
*
*
*
*
*
*
1.00
0.00
DUAL MODE
1. Please refer to the package insert for ALAT (GPT) FS
(IFCC Mod.) for detailed information as per the following:
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr Depletion
Reagent blank
ALAT
No
25 ml
240 µl
259 µl
24 µl
5 µl
5 ml
60 µl
60 µl
50,186 sec
No
15 %
0.850
3.00
-0.100
0.300
-0.750
Yes (#)
Factor
-2143
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
ALAT
No
25 µl
300 µl
319 µl
24 µl
5 µl
51,175 sec
15 %
0.850
3.00
-0.100
0.300
0.200
Yes (#)
Factor
-2143
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyzer is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyzer
845 2701 90 02 51
845 2701 90 82 51
November 2007/6
Selectra/Flexor
ALAT (GPT) FS (IFCC Mod.)
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
with Pyridoxal-5-Phosphate
ALAT
ALT
Kinetic
340 nm
U/l
I
0
500
None
-
Order information
Cat. No. 1 2701.. .. …
Notes
No
*
*
*
*
*
*
*
*
*
1.00
0.00
DUAL MODE
1. Please refer to the package insert for ALAT (GPT) FS
(IFCC Mod.) for detailed information as per the following:
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr Depletion
Reagent blank
ALAT
No
25 ml
240 µl
259 µl
24 µl
5 µl
5 ml
60 µl
60 µl
50,186 sec
No
15 %
0.850
3.00
-0.100
0.300
-0.750
Yes (#)
Factor
-2143
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyzer is at least
one month provided that contamination and evaporation are
avoided.
4. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
Factor
This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyzer
845 2701 90 02 51
845 2701 90 82 51
November 2007/6
Selectra/Flexor
α-AMYLASE CC FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Amylase
AMY
KINETIC
405
U/L
0
0
2000
Cat. No. 1 0501 .. .. …
Notes
NO
*
*
*
*
*
*
1. Please refer to the package insert for α-Amylase CC FS
for detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
1.000
0.000
DUAL MODE
MONO MODE
R1 bottle
Normal Volume
Rerun Volume
Probe
Sample Normal Vol.
Sample Vol. rerun
R2 bottle
4µl
2µl
5 ml
Normal Volume
50µl
Rerun Volume
Predilution
Slope blank
Delay, min. time
50µl
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R.Abs Diviation
Reagent blank
Cal. Low Limit
Cal.High Limit
Factor
Order information
25 ml
200µl
202µl
103,133
secs
10.0
-0.100
1.500
-0.100
0.800
2.300
Yes
Sample blank
R1 bottle
Normal volume
Rerun volume
Sample
Normal Volume
rerun Volume
Point one, two
Incubation times
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
Cal Low Limit
Cal. High Limit
Factor
NO
25µl
250µl
251µl
4µl
3µl
129,59
secs
10.0
-0.100
1.200
-0.100
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
0.800
2.000
Yes
5670
**This application was set up and evaluated at DiaSys. It is
based on the standard equipment at that time and does not
apply to any equipment modifications undertaken by the
manufacturer or by other persons.
5670
* can be selected freely
# calculated by the analyser
845 0501 90 02 51
November 2007/5
Selectra/Flexor
ALKALINE PHOSPHATASE FS DGKC
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
AP DGKC
APDG
Kinetic
405 nm
U/l
I
0.0 U/l
2300.0 U/l
None
-
Factor
Cat. No. 1 0401 .. .. …
Notes
No
*
*
*
*
*
*
*
*
*
1.00
0.00 U/l
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R. Abs. Deviation
Reagent blank
Order information
1. Please refer to the package insert for
Alkaline phosphatase FS DGKC for detailed
information about the test on the following:
MONO MODE
AP DGKC
No
25 ml
200 µl
202 µl
4.0 µl
2.0 µl
5 ml
50 µl
50 µl
50, 186 sec
No
10.0 %
-0.100 Abs
3.00 Abs
-0.100 Abs
0.500 Abs
Yes (#)
3433.0
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
AP DGKC
No
25 ml
250 µl
251 µl
Factor
2757.0
5.0 µl
4.0 µl
70, 78 sec
10.0 %
-0.100
3.00
-0.100
3.000
3.000
Yes (#)
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 0401 90 02 51
November 2007/6
Selectra/Flexor
ALKALINE PHOSPHATASE FS
IFCC 37° C
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
AP IFCC
APIF
Kinetic
405 nm
U/l
I
0.0 U/l
2800.0 U/l
None
-
Order information
Cat. No. 1 0441 .. .. …
Notes
No
*
*
*
*
*
*
*
*
*
1.00
0.00
DUAL MODE
1. Please refer to the package insert for
Alkaline phosphatase FS IFCC for detailed
information about the test on the following:
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr Depletion
Reagent blank
AP IFCC
No
25 ml
200 µl
203 µl
5.0 µl
2.0 µl
5 ml
50 µl
50 µl
77, 79 sec
No
10.0 %
-0.100
3.00
-0.100
3.000
3.000
Yes (#)
Factor
2757.0
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
AP IFCC
No
25 ml
250 µl
251 µl
Factor
2757.0
5.0 µl
4.0 µl
70, 78 sec
10.0 %
-0.100
3.00
-0.100
3.000
3.000
Yes (#)
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 0441 90 02 51
November 2007/6
Selectra/Flexor
APOLIPOPROTEIN A1 FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Apolipoprotein A
ApoA
Two-point
578 nm
mg/dl
2
16.00 mg/dl
230.0 mg/dl
TruCal Apo A1/B
3
4
Multi*
Selectra 2 – Non Linear
Selectra XL – 4PLL
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
ApoA
No
25 ml
250 µl
251 µl
2.0 µl
1.0 µl
5 ml
50 µl
50 µl
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7102 .. .. …
Notes
1. Please refer to the package insert for Apoliporotein A1 FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7102 90 02 51
September 2008/7
Selectra/Flexor
APOLIPOPROTEIN B FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Apolipoprotein B
ApoB
Two-point
340 nm
mg/dl
2
0.000 mg/dl
230.0 mg/dl
TruCal ApoA1/ B
3
4
Multi*
Selectra 2 – Non Linear
Selectra XL – 4PLL
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
ApoB
No
25 ml
250 µl
252 µl
3.0 µl
1.0 µl
5 ml
50 µl
50 µl
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7112 .. .. …
Notes
1. Please refer to the package insert for Apoliporotein B FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7112 90 02 51
September 2008/7
Selectra/Flexor
ANTISTREPTOLYSIN O FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibrator Modes
Antistrept. O
ASO
Two-point
505 nm
IU/ml
1
0.00 IU/ml
800.0 IU/ml
TruCal ASO
3
6
Multi*
Selectra 2 – Non Linear
Selectra XL – 4PLL
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/l
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
ASO
No
25 ml
250 µl
252 µl
3.0 µl
1.0 µl
5 ml
50 µl
50 µl
No
No
6 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7012.. .. …
Notes
1. Please refer to the package insert for Antistreptolysin O FS
for detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7012 90 02 51
September 2008/7
Selectra/Flexor
ASAT(GOT) FS (IFCC Mod)
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
ASAT
AST
Kinetic
340 nm
U/l
I
0 U/l
500 U/l
None
-
Cat. No. 1 2601 .. .. …
Notes
No
*
*
*
*
*
*
*
*
*
1.00
0.00
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr Depletion
Reagent Blank
Factor
Order information
1. Please refer to the package insert for
ASAT (GOT) FS (IFCC Mod) for detailed
information about the test on the following:
MONO MODE
ASAT
No
25 ml
240 µl
259 µl
24 µl
5 µl
5 ml
60 µl
64 µl
50,186 sec
No
15 %
0.600 Abs
3.00 Abs
-0.100 Abs
0.300 Abs
-0.500 Abs
Yes(#)
-2143
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
ASAT
No
25 ml
300 µl
319 µl
24 µl
5 µl
51,175 sec
15 %
0.600
3.00
-0.100
0.300
0.200
Yes (#)
Factor
-2143
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyzer is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyzer
845 2601 90 02 51
845 2601 90 82 51
November 2007/6
Selectra/Flexor
ASAT(GOT) FS (IFCC Mod)
with Pyridoxal-5-Phosphate
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
ASAT
AST
Kinetic
340 nm
U/l
I
0 U/l
500 U/l
None
-
Cat. No. 1 2601 .. .. …
Notes
1. Please refer to the package insert for
ASAT (GOT) FS (IFCC Mod) for detailed
information about the test on the following:
No
*
*
*
*
*
*
*
*
*
1.00
0.00
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr Depletion
Reagent Blank
Factor
Order information
MONO MODE
ASAT
No
25 ml
240 µl
259 µl
24 µl
5 µl
5 ml
60 µl
64 µl
50,186 sec
No
15 %
0.600 Abs
3.00 Abs
-0.100 Abs
0.300 Abs
-0.500 Abs
Yes(#)
-2143
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
Factor
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyzer is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyzer
845 2601 90 02 51
845 2601 90 82 51
November 2007/6
BILIRUBIN AUTO DIRECT FS
Selectra/Flexor
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Bilirubin Direct
DBili
Two-point
546 nm
mg/dl
1
0.000 mg/dl
10.00 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr. Depletion
Reagent blank
Cal Low limit
Cal High limit
Factor
MONO MODE
DBili
No
25 ml
240 µl
250 µl
25.0 µl
15.0 µl
5 ml
60 µl
60 µl
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
0.500 Abs
3.000 Abs
Yes (#)
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R.Abs. Deviation
Reagent blank
Cal Low limit
Cal High limit
Order information
Cat. No. 1 0821 .. .. …
Notes
1. Please refer to the package insert for Bilirubin Auto Direct FS
for detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 0821 90 02 51
August 2010/8
BILIRUBIN AUTO TOTAL FS
Selectra/Flexor
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Bilirubin Total
TBili
Two-point
546 nm
mg/dl
1
0.000 mg/dl
30.00 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
TBili
No
25 ml
240 µl
244 µl
6.0 µl
2.0 µl
5 ml
60 µl
60 µl
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
0.500 Abs
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R.Abs. Deviation
Reagent blank
Cal Low limit
Cal High limit
Order information
Cat. No. 1 0811 .. .. …
Notes
1. Please refer to the package insert for Bilirubin Auto Total FS
for detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 0811 90 02 51
August 2010/8
Selectra/Flexor
COMPLEMENT C3c FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Complement C3c
C3c
Two-point
340 nm
mg/dl
2
0.000 mg/dl
360.00 mg/dl
TruCal Protein
3
6
Multi*
Selectra 2 – Non Linear
Selectra XL - Standard Cubic Spline
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
Order information
Cat. No. 1 1802 .. .. …
Notes
1. Please refer to the package insert for Complement C3c FS
for detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
C3c
No
25 ml
250 µl
252 µl
4.0 µl
2.0 µl
5 ml
50 µl
50 µl
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 1802 90 02 51
September 2008/7
Selectra/Flexor
COMPLEMENT C4 FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Complement C4
C4
Two-point
340 nm
mg/dl
2
0.000 mg/dl
60.00 mg/dl
TruCal Protein
3
6
Multi*
Selectra 2 – Non Linear
Selectra XL - Standard Cubic Spline
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
Order information
Cat. No. 1 1812 .. .. …
Notes
1. Please refer to the package insert for Complement C4 FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
C4
No
25 ml
250 µl
254 µl
7.0 µl
3.0 µl
5 ml
50 µl
50 µl
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 1812 90 02 51
September 2008/7
Selectra/Flexor
CALCIUM CPC FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Calcium CPC
Ca
Endpoint
578 nm
mg/dl
2
0.000 mg/dl
20.000 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Order information
Cat. No. 1 1121 .. .. …
Notes
1. Please refer to the package insert for Calcium CPC FS for
detailed information about the test on the following:
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Ca
No
25 ml
240 µl
242 µl
4.0 µl
2.0 µl
5 ml
60 µl
60 µl
No
6.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Ca
No
25 ml
300 µl
301 µl
4.0 µl
3.0 µl
11.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 1121 90 02 51
September 2008/7
Selectra/Flexor
CHOLINESTERASE FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Cholinesterase
CHE
Kinetic
405 nm
U/l
I
0.000 U/l
20000 U/l
None
No
*
*
*
*
*
*
*
*
*
1.00
0.00 U/l
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R. Abs. Deviation
Reagent Blank
Factor
Order information
Cat. No. 1 1401 .. .. …
Notes
1. Please refer to the package insert for Cholinesterase FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
CHE
No
25 ml
200 µl
202 µl
4.0 µl
2.0 µl
5 ml
50 µl
50 µl
103, 133 sec
No
10.0 %
0.000 Abs
3.000 Abs
-0.100 Abs
0.300 Abs
Yes (#)
-68500
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
Factor
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 1401 90 02 51
November 2007/7
Selectra/Flexor
CHOLESTEROL FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Cholesterol
Chol
Endpoint
546 - 620 nm
mg/dl
I
0.000 mg/dl
800.0 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Order information
Cat. No. 1 1300 .. .. …
Notes
1. Please refer to the package insert for Cholesterol FS for
detailed information about the test on the following:
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Cholesterol
No
25 ml
300 µl
302 µl
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
3.0 µl
1.0 µl
5 ml
0 µl
0 µl
No
11.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Cholesterol
No
25 ml
300 µl
301 µl
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
3.0 µl
2.0 µl
11.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 1300 90 02 51
September 2008/7
CK-NAC FS
Selectra/Flexor
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Creatine kinase
CK
Kinetic
340 nm
U/l
I
0.0
1000.0
None
-
Order information
Cat. No. 1 1601 .. .. …
Notes
1. Please refer to the package insert for CK-NAC FS for
detailed information about the test on the following:
No
*
*
*
*
*
*
*
*
*
1.00
0.00
DUAL MODE
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr Depletion
CK
No
25 ml
200 µl
202 µl
No
10.0 %
-0.100 Abs
3.00 Abs
-0.100 Abs
3.00 Abs
3.00 Abs
Factor
4127
10.0 µl
8.0 µl
5 ml
50 µl
50 µl
103, 133 sec
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
Substr. Depletion
Reagent blank
CK
No
25 ml
250 µl
252 µl
Factor
4127
10.0 µl
8.0 µl
168, 254 sec
10.0 %
-0.100 Abs
3.00 Abs
-0.100 Abs
3.00 Abs
3.00 Abs
Yes (#)
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 1601 90 02 51
November 2007/6
Selectra/Flexor
CHLORIDE FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Chloride
Cl
Endpoint
436 - 620 nm
mmol/l
1
80.000 mmol/l
140.00 mmol/l
Standard
3
1
*
Linear
14 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Order information
Cat. No. 1 1200 .. .. …
Notes
1. Please refer to the package insert for Chloride FS for
detailed information about the test on the following:
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Chloride
No
25 ml
300 µl
301 µl
3.0 µl
2.0 µl
5 ml
0 µl
0 µl
No
11.5 min
-0.100 Abs
3.000 Abs
-0.100
3.000
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Chloride
No
25 ml
300 µl
301 µl
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
3.0 µl
2.0 µl
11.5 min
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
2. The stability of the reagent on board the analyser is 7 days
provided that contamination and evaporation are avoided.
* can be selected freely
# calculated by the analyser
845 1200 90 02 51
September 2009/5
Selectra/Flexor
CREATININE FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Creatinine Jaffe
CreJ
Two-point
505 nm
mg/dl
2
0.000 mg/dl
15.00 mg/dl
TruCal U
3
1
*
Linear
1 day
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R.Abs. Deviation
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 1711 .. .. …
Notes
1. Please refer to the package insert for Creatinine FS for
detailed information about the test on the following:
MONO MODE
CreJ
No
25 ml
200 µl
208 µl
10.0 µl
2.0 µl
5 ml
50 µl
50 µl
No
50 130 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R.Abs. Deviation
Reagent blank
Cal Low limit
Cal High limit
Factor
CreJ
No
25 ml
250 µl
250 µl
10.0 µl
10.0 µl
51, 129 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
*
*
#
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is 9 days
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 1711 90 02 51
February 2009/9
Selectra/Flexor
CREATININE FS
TEST PARAMETERS
Compensated Method
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Creatinine Jaffe
CreJ
Two-point
505 nm
mg/dl
2
0.000 mg/dl
15.00 mg/dl
TruCal U
3
1
*
Linear
1 day
No
No
*
*
*
*
*
*
*
*
*
1.000
- 0.300 mg/dl
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R.Abs. Deviation
Reagent blank
Cal Low limit
Cal High limit
Factor
To use the Creatinine FS Compensated Method on the Selectra/
Flexor the Correlation Offset must be changed as follows;
When the units are mg/dL
Correlation Offset
- 0.3
When the units are µmol/L
Correlation Offset
- 27
Note: Ensure that the relevant assigned calibrator value is
selected when using the Creatinine Compensated Method.
MONO MODE
CreJ
No
25 ml
200 µl
208 µl
10.0 µl
2.0 µl
5 ml
50 µl
50 µl
No
50, 130 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R.Abs. Deviation
Reagent blank
Cal Low limit
Cal High limit
Factor
CreJ
No
25 ml
250 µl
250 µl
10.0 µl
10.0 µl
51, 129 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
*
*
#
* can be selected freely
# calculated by the analyser
845 1711 90 02 51
February 2009/9
Selectra/Flexor
CREATININE PAP FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Creatinine PAP
CreP
Enppoint
546 nm
mg/dl
2
0.000 mg/dl
160.00 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Order information
Cat. No. 1 1759 .. .. …
Notes
1. Please refer to the package insert for Creatinine PAP FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Incubation
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
CreP
No
25 ml
200 µl
206 µl
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
8.0 µl
2.0 µl
25 ml
100 µl
100 µl
No
No
6.5 min
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R.Abs. Deviation
Reagent blank
Cal Low limit
Cal High limit
Factor
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 1759 90 02 51
April 2011/6
Selectra/Flexor
CRP FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
CRP
CRP
Two-point
340 nm
mg/l
2
2.00 mg/l
250.0 mg/l
TruCal CRP
3
6
Multi*
Selectra 2 – Non Linear
Selectra XL – 4PLL
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/l
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
CRP
No
25 ml
250 µl
260 µl
15.0 µl
5.0 µl
5 ml
50 µl
50 µl
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7002 .. .. …
Notes
1. Please refer to the package insert for CRP FS for detailed
information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7002 90 02 51
September 2008/7
Selectra/Flexor
CRP U-hs
High sensitive (hs) application
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
CRP U-hs
CRP
Two-point
505 nm
mg/l
2
0.05 mg/l
20.0 mg/l
TruCal CRP hs
2
6
Multi*
Selectra 2 – Non Linear
Selectra XL - Standard Cubic Spline
7 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/l
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
CRP
No
25 ml
150 µl
160 µl
15.0 µl
5.0 µl
5 ml
150 µl
150 µl
No
No
6 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7045 .. .. …
Notes
1. Please refer to the package insert for CRP U-hs for detailed
information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7045 90 42 51
September 2008/5
Selectra/Flexor
CRP U-hs
Universal (U) application
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
CRP U-hs
CRP
Two-point
505 nm
mg/l
2
3.00 mg/l
500.0 mg/l
TruCal CRP U
2
6
Multi*
Selectra 2 – Non Linear
Selectra XL - Standard Cubic Spline
10 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/l
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
CRP
No
25 ml
198 µl
200 µl
4.0 µl
2.0 µl
5 ml
198 µl
198 µl
No
No
24 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
0.100 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7045 .. .. …
Notes
1. Please refer to the package insert for CRP U-hs for detailed
information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7045 90 32 51
September 2008/5
Selectra/Flexor
CRP U-hs
High sensitive (hs) application
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
CRP U-hs
CRP
Two-point
505 nm
mg/l
2
0.05 mg/l
20.0 mg/l
TruCal CRP hs
2
6
Multi*
Selectra 2 – Non Linear
Selectra XL - Standard Cubic Spline
7 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/l
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
CRP
No
25 ml
150 µl
160 µl
15.0 µl
5.0 µl
5 ml
150 µl
150 µl
No
No
6, 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7045 .. .. …
Notes
1. Please refer to the package insert for CRP U-hs for detailed
information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7045 90 42 51
September 2008/5
Selectra/Flexor
CRP U-hs
Universal (U) application
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
CRP U-hs
CRP
Two-point
505 nm
mg/l
2
3.00 mg/l
500.0 mg/l
TruCal CRP U
2
6
Multi*
Selectra 2 – Non Linear
Selectra XL - Standard Cubic Spline
10 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/l
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
CRP
No
25 ml
198 µl
200 µl
4.0 µl
2.0 µl
5 ml
198 µl
198 µl
No
No
24, 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
0.100 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7045 .. .. …
Notes
1. Please refer to the package insert for CRP U-hs for detailed
information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7045 90 32 51
September 2008/5
Selectra/Flexor
IRON FS Ferene
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Iron Ferene
Fe
Two point
578 nm
µg/dl
Cat. No. 1 1911 .. .. …
0.000 µg/dl
1000.0 µg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 µg/dl
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Point one, two
Slope blank
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Order information
MONO MODE
Iron Ferene
No
25 ml
240 µl
250 µl
Reagent blank
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
15.0 µl
normal Volume
5.0 µl
rerun Volume
5 ml
Incubation time
60 µl
Low Absorbance
60 µl
High Absorbance
No
R.Abs.L.Limit
-3 236 sec R.Abs. H.Limit
No
-0.100 Abs
3.000 Abs
Reagent blank
-0.100
Cal Low limit
0.500
Cal High limit
Factor
Yes (#)
Factor
#
Notes
1. Please refer to the package insert for Iron FS Ferene for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 1911 90 02 51
September 2008/7
Selectra/Flexor
FERRITIN FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Ferritin
Ferr
Two-point
578 nm
µg/l
I
0.00 µg/l
1000.00 µg/l
TruCal Ferritin
3
5
Multi*
Selectra 2 – Non Linear
Selectra XL - Standard Cubic Spline
14 days
No
1.000 %
No
*
*
*
*
*
*
*
*
*
1.000
0.000 µg/l
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
Order information
Cat. No. 1 7059 .. .. …
Notes
1. Please refer to the package insert for Ferritin FS for
detailed information about the test on the following
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
Ferr
No
25 ml
200 µl
205 µl
10.0 µl
5.0 µl
5 ml
100 µl
100 µl
No
No
6 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7059 90 02 51
September 2008/7
Selectra/Flexor
TEST PARAMETERS WITH FACTOR
ACCORDING TO SZASZ
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Gamma-GT SZASZ
GGT
Kinetic
405 nm
U/l
I
0.000 U/l
750.0 U/l
None
-
Order information
Cat. No. 1 2801 .. .. …
Notes
No
*
*
*
*
*
*
*
*
*
1.00
0.00
DUAL MODE
1. Please refer to the package insert for Gamma-GT FS (Szasz mod.)
for detailed information about the test on the following:
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr Depletion
Reagent blank
GGT
No
25 ml
200 µl
210 µl
No
10.0 %
-0.100
3.00
-0.100
3.000
3.000
Yes (#)
Factor
1421.0
20.0 µl
10.0 µl
5 ml
50 µl
50 µl
103, 133 sec
GAMMA GT FS (Szasz mod.)
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
GGT
No
25 ml
250 µl
260 µl
Factor
1158.0
25.0 µl
15.0 µl
90, 58 sec
10.0 %
-0.100
3.00
-0.100
3.000
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
Yes (#)
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 2801 90 02 51
November 2007/6
Selectra/Flexor
TEST PARAMETERS WITH FACTOR
ACCORDING TO IFCC
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Gamma-GT SZASZ
GGT
Kinetic
405 nm
U/l
I
0.000 U/l
850.0 U/l
None
-
Order information
Cat. No. 1 2801 .. .. …
Notes
No
*
*
*
*
*
*
*
*
*
1.00
0.00
DUAL MODE
1. Please refer to the package insert for Gamma-GT FS (Szasz mod.)
for detailed information about the test on the following:
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr Depletion
Reagent blank
GGT
No
25 ml
200 µl
210 µl
No
10.0 %
-0.100
3.00
-0.100
3.000
3.000
Yes (#)
Factor
1606.0
20.0 µl
10.0 µl
5 ml
50 µl
50 µl
103, 133 sec
GAMMA GT FS (Szasz mod.)
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
GGT
No
25 ml
250 µl
260 µl
Factor
1309.0
25.0 µl
15.0 µl
90, 58 sec
10.0 %
-0.100
3.00
-0.100
0.500
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
4. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
Yes (#)
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 2801 90 02 51
November 2007/6
Selectra/Flexor
GLUCOSE HEXOKINASE FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Glucose Hexokinase
Gluc
Endpoint
340 nm
mg/dl
2
0.000 mg/dl
650.00 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Order information
Cat. No. 1 2511 .. .. …
Notes
1. Please refer to the package insert for Glucose
Hexokinase FS for detailed information about the test on the
following:
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Gluc
No
25 ml
240 µl
242 µl
3.0 µl
1.0 µl
5 ml
60 µl
60 µl
No
6.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Gluc
No
25 ml
300 µl
301 µl
3.0 µl
2.0 µl
11.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 2511 90 02 51
September 2008/7
Selectra/Flexor
HbA1c FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration modes
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
HbA1c
HbA1c
one-point
620 nm
##
2
0
20
TruCal HbA1c liquid 4 level
2
5 (NaCl + 4 levels)
Multi*
Selectra 2 - Non linear
Selectra XL – 4PLL
10 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
R3 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Order information
Cat. No. 1 3329 .. .. …
Notes
1. Please refer to the package insert for oneHbA1c FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
HbA1c
No
25 ml
220 µl
223 µl
5.0 µl
2.0 µl
5 ml
75 µl
75 µl
5 ml
35 µl
35 µl
No
No
6.5 min
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Cal Low limit
Multi dAbs*
Cal High limit
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
2. The stability of the reagent on board the analyser is at least
3 weeks provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
Reagent blank
Cal Low limit
Cal High limit
Factor
NOTE: For optimal performance the HbA1c should be run as a
batch and a cuvette wash with NaOH as cleaner 14
performed after the assay. After the cuvette wash has
finished NaOH should be replaced with the HCl.
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
## Data entry by the user
845 3329 90 02 51
August 2010/7
Selectra/Flexor
IMMUNOGLOBULIN A FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Immunoglobulin A
Ig A
Two-point
578 nm
mg/dl
I
0.000 mg/dl
900.0 mg/dl
TruCal Protein
3
6
Multi*
Selectra 2 – Non Linear
Selectra XL – 4PLL
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
Ig M
No
25 ml
250 µl
251 µl
2.0 µl
1.0 µl
5 ml
50 µl
50 µl
No
No
-3 209 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7202 .. .. …
Notes
1. Please refer to the package insert for Immunoglobulin A FS
for detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7202 90 02 51
September 2008/7
Selectra/Flexor
IMMUNOGLOBULIN G FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Immunoglobulin G
Ig G
Two-point
578 nm
mg/dl
I
0.000 mg/dl
3100.0 mg/dl
TruCal Protein
3
6
Multi*
Selectra 2 – Non Linear
Selectra XL – 4PLL
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
Ig G
No
25 ml
300 µl
301 µl
2.0 µl
1.0 µl
5 ml
60 µl
60 µl
No
No
-3 209 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7212 .. .. …
Notes
1. Please refer to the package insert for Immunoglobulin G FS
for detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7212 90 02 51
September 2008/7
Selectra/Flexor
IMMUNOGLOBULIN M FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Immunoglobulin M
Ig M
Two-point
405 nm
mg/dl
I
0.000 mg/dl
800.0 mg/dl
TruCal Protein
3
6
Multi*
Selectra 2 – Non Linear
Selectra XL – 4PLL
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
Ig M
No
25 ml
300 µl
301 µl
2.0 µl
1.0 µl
5 ml
60 µl
60 µl
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7222 .. .. …
Notes
1. Please refer to the package insert for Immunoglobulin M FS
for detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7222 90 02 51
September 2008/7
Selectra/Flexor
LACTATE FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Lactate
Lac
Endpoint
340 nm
mg/dl
1
0.000 U/l
120.0 U/l
DiaSys
3
1
*
Linear
0
No
No
*
*
*
*
*
*
*
*
*
1.00
0.00 U/l
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Incubation Time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 4001 .. .. …
Notes
1. Please refer to the package insert for Lactate FS for detailed
information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
Lac
No
25 ml
240 µl
242 µl
4.0 µl
2.0 µl
5 ml
60 µl
60 µl
6.5 min
0.000 Abs
3.000 Abs
0.000 Abs
3.000 Abs
Yes (#)
*
*
1.00
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 4001 90 02 51
September 2008/5
Selectra/Flexor
LDH FS DGKC
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
LDH DGKC
LDHD
Kinetic
340 nm
U/l
0
0.000 U/l
2000.0 U/l
None
No
*
*
*
*
*
*
*
*
*
1.00
0.00 U/l
DUAL MODE
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R. Abs. Deviation
Substr Depletion
LDH DGKC
No
25 ml
250 µl
252 µl
5.0 µl
2.0 µl
5 ml
63 µl
64 µl
50, 186 sec
No
10.0 %
-0.400 Abs
3.000 Abs
-0.100
3.000 Abs
0.200 Abs
-0.400 Abs
Factor
-10095.0
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
Factor
Order information
Cat. No. 1 4201 .. .. …
Notes
1. Please refer to the package insert for LDH.FS DGKC for the
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 4201 90 02 51
November 2007/6
Selectra/Flexor
LDH FS IFCC
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
LDH IFCC
LDHI
Kinetic
340 nm
U/l
I
0.000 U/l
1500.0 U/l
None
No
*
*
*
*
*
*
*
*
*
1.00
0.00 U/l
DUAL MODE
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr Depletion
Reagent Blank
LDH IFCC
No
25 ml
200 µl
203 µl
4.0 µl
1.0 µl
5 ml
50 µl
50 µl
77, 159 sec
No
10.0 %
-0.100 Abs
3.000 Abs
-0.100
3.000 Abs
3.000 Abs
Yes(#)
Factor
10080.0
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
Factor
Order information
Cat. No. 1 4211 .. .. …
Notes
1. Please refer to the package insert for LDH FS IFCC for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 4211 90 02 51
November 2007/7
Selectra/Flexor
LIPASE DC FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Lipase DC
LIPA
Kinetic
578 nm
U/l
I
0.000 U/l
250.0 U/l
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.00
0.00 U/l
DUAL MODE
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R.Abs. Deviation
Reagent Blank
LIPA
No
25 ml
200 µl
203 µl
No
10.0 %
-0.100 Abs
3.00 Abs
-0.100 Abs
3.00 Abs
3.00 Abs
Yes(#)
Factor
#
5.0 µl
2.0 µl
5 ml
50 µl
50 µl
130, 106 sec
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
Substr. Depletion
Reagent blank
Factor
Order information
Cat. No. 1 4321 .. .. …
Notes
1. Please refer to the package insert for Lipase DC FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 4321 90 02 51
September 2008/7
Selectra/Flexor
MAGNESIUM XL FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Magnesium
Mg
Endpoint
546 nm
mg/dl
2
0.000 mg/dl
5.000 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Order information
Cat. No. 1 4610 .. .. …
Notes
1. Please refer to the package insert for Magnesium XL FS for
detailed information about the test on the following:
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Magnesium
No
25 ml
300 µl
301 µl
3.0 µl
2.0 µl
5 ml
0 µl
0 µl
No
4.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Magnesium
No
25 ml
300 µl
301 µl
3.0 µl
2.0 µl
11.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 4610 90 02 51
September 2008/4
Selectra/Flexor
MYOGLOBIN FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Myoglobin
Myo
Two-point
578 nm
µg/l
I
0.00 µg/l
520.00 µg/l
TruCal Myoglobin
3
5
Multi*
Selectra 2 – Non Linear
Selectra XL - Standard Cubic Spline
1 days
No
0.100 %
No
*
*
*
*
*
*
*
*
*
1.000
0.000 µg/l
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
Order information
Cat. No. 1 7098 .. .. …
Notes
1. Please refer to the package insert for Myoglobin FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
Myo
No
25 ml
210 µl
213 µl
7.0 µl
4.0 µl
5 ml
70 µl
70 µl
No
No
24 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7098 90 02 51
September 2008/5
Selectra/Flexor
PREALBUMIN FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Interval
Curve Fit
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Prealbumin
PreAlb
Two-point
405 nm
g/L
3
0.04 g/L
1.50 g/L
TruCal Protein
3
6 (NaCl + 5 levels)
Multi*
*
4PLL
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 g/L
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr. Depletion
Reagent blank
Cal Low limit
Cal High limit
Factor
MONO MODE
PALB
No
25 mL
250 µL
252 µL
3.0 µL
1.0 µL
5 mL
50 µL
50 µL
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs
Multi dAbs
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
R.Abs. Deviation
Reagent blank
Cal Low limit
Cal High limit
Order information
Cat. No. 1 0292 .. .. …
Notes
1. Please refer to the package insert for Prealbumin FS
for detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 0292 90 02 51
February 2008/5
Selectra/Flexor
PHOSPHATE FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Phosphate
Phos
Endpoint
340 nm
mg/dl
2
-1.000 mg/dl
40.000 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.00
0.000 g/dl
DUAL MODE
Order information
Cat. No. 1 5211 .. .. …
Notes
1. Please refer to the package insert for Phosphate FS for detailed
information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Phosphate
No
25 ml
240 µl
242 µl
3.0 µl
1.0 µl
5 ml
60 µl
60 µl
No
6.5 min
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Phosphate
No
25 ml
300 µl
300 µl
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
3.0 µl
3.0 µl
11.5 min
0.000 Abs
3.000 Abs
0.000 Abs
3.000 Abs
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 5211 90 02 51
September 2008/5
Selectra/Flexor
RHEUMATOID FACTOR FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Rheumatoid factor
RF
Two-point
340 nm
IU/ml
I
0.000 IU/ml
500.0 IU/ml
TruCal RF
3
6
Multi*
Selectra 2 – Non Linear
Selectra XL - Standard Cubic Spline
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 IU/ml
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
MONO MODE
Rf
No
25 ml
250 µl
260 µl
15.0 µl
5.0 µl
5 ml
50 µl
50 µl
No
No
-3 236 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 7022 .. .. …
Notes
1. Please refer to the package insert for Rheumatoid Factor FS
for detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7022 90 02 51
September 2008/8
Selectra/Flexor
TOTAL PROTEIN FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Total Protein
TP
Endpoint
546 nm
g/dl
I
0.000 g/dl
15.000 gd/l
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.00
0.000 g/dl
DUAL MODE
Order information
Cat. No. 1 2311 .. .. …
Notes
1. Please refer to the package insert for Total Protein FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
Total Protein
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
5.0 µl
4.0 µl
5 ml
60 µl
60 µl
No
4.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
No
25 ml
240 µl
241 µl
Total Protein
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
5.0 µl
4.0 µl
11.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
No
25 ml
300 µl
301 µl
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 2311 90 02 51
September 2008/6
Selectra/Flexor
TRANSFERRIN FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Modes
Transferrin
TRF
Two-point
578 nm
mg/dl
I
0.000 mg/dl
800.0 mg/dl
TruCal Protein
3
6
Multi*
Selectra 2 – Non Linear
Selectra XL – 4PLL
14 days
No
1.000%
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
Interval
Cut off
Max. inaccuracy
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr depletion
Reagent blank
Cal Low limit
Cal High limit
Order information
Cat. No. 1 7252 .. .. …
Notes
1. Please refer to the package insert for Transferrin FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
TRF
No
25 ml
250 µl
252 µl
3.0 µl
1.0 µl
5 ml
50 µl
50 µl
No
No
-3 130 sec
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
3.000 Abs
No
Multi dAbs*
Multi dAbs*
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 7252 90 02 51
September 2008/7
Selectra/Flexor
TRIGLYCERIDES FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Triglyceride
TRIG
Endpoint
546 nm
mg/dl
I
0.000 mg/dl
1400.0 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Order information
Cat. No. 1 5710 .. .. …
Notes
1. Please refer to the package insert for Triglycerides FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Triglyceride
No
25 ml
300 µl
302 µl
3.0 µl
1.0 µl
5 ml
0 µl
0 µl
No
11.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Triglyceride
No
25 ml
300 µl
301 µl
3.0 µl
2.0 µl
11.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 5710 90 02 51
September 2008/7
Selectra/Flexor
TRIGLYCERIDES FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Triglyceride
TRIG
Endpoint
546 nm
mg/dl
I
0.000 mg/dl
1400.0 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Order information
Cat. No. 1 5760 .. .. …
Notes
1. Please refer to the package insert for Triglycerides FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Triglyceride
No
25 ml
300 µl
302 µl
3.0 µl
1.0 µl
5 ml
0 µl
0 µl
No
11.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Triglyceride
No
25 ml
300 µl
301 µl
3.0 µl
2.0 µl
11.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 5760 90 02 51
September 2008/2
Selectra/Flexor
URIC ACID FS TBHBA
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Uric Acid TBHBA
UATB
Endpoint
546 nm
mg/dl
2
0.000 mg/dl
25.00 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs. L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Order information
Cat. No. 1 3021 .. .. …
Notes
1. Please refer to the package insert for Uric Acid FS TBHBA
for detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
UATB
No
25 ml
240 µl
243 µl
5.0 µl
2.0 µl
5 ml
60 µl
60 µl
No
No
6,5 min
-0.100 Abs
3.000 Abs
-0.100 Abs
1.000 Abs
Yes (#)
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid
misinterpretation measured results have to be validated and
assessed with caution.
* can be selected freely
# calculated by the analyser
October 2011/1
Selectra/Flexor
URIC ACID FS TBHBA
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Uric Acid TBHBA
UATB
Endpoint
546 nm
mg/dl
2
0.000 mg/dl
25.00 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
Order information
Cat. No. 1 3021 .. .. …
Notes
1. Please refer to the package insert for Uric Acid FS TBHBA
for detailed information about the test on the following:
DUAL MODE
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
5 µl
3 µl
11.5 min
-0.100 Abs
3.000 Abs
-0.100 Abs
0.500 Abs
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Reagent blank
Cal Low limit
Cal High limit
Factor
UATB
No
25 ml
300 µl
302 µl
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 3021 90 02 51
September 2008/7
Selectra/Flexor
URIC ACID (TOOS) FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Uric Acid TOOS
UATO
Endpoint
546 nm
mg/dl
2
0.000 mg/dl
25.00 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Order information
Cat. No. 1 3001 .. .. …
Notes
1. Please refer to the package insert for Uric Acid FS for
detailed information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
UATO
No
25 ml
240 µl
242 µl
5.0 µl
3.0 µl
5 ml
60 µl
60 µl
No
6.5 min
-0.100 Abs
3.000 Abs
-0.100
0.500
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes (#)
*
*
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 3001 90 02 51
September 2006/7
Selectra/Flexor
UIBC FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
UIBC
UIBC
Two point
578 nm
µg/dl
6.000 µg/dl
1000.0 µg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 µg/dl
DUAL MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Point one, two
Slope blank
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
MONO MODE
UIBC
No
25 ml
240 µl
249 µl
Reagent blank
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
18.0 µl
normal Volume
9.0 µl
rerun Volume
5 ml
Incubation time
60 µl
Low Absorbance
60 µl
High Absorbance
No
R.Abs.L.Limit
-3 236 sec R.Abs. H.Limit
No
-0.100 Abs
3.000 Abs
Reagent blank
-0.100
Cal Low limit
3.000
Cal High limit
Factor
Yes (#)
Factor
#
Order information
Cat. No. 1 1921 .. .. …
Notes
1. Please refer to the package insert for UIBC FS for detailed
information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 1921 90 02 51
Septemebr 2008/5
Selectra/Flexor
UREA FS
TEST PARAMETERS
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Urea
UREA
Kinetic
340 nm
mg/dl
I
0.000 mg/dl
300.0 mg/dl
TruCal U
3
1
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
DUAL MODE
Order information
Cat. No. 1 3101 .. .. …
Notes
1. Please refer to the package insert for Urea FS for detailed
information about the test on the following:
Clinical Relevance
Method and Principle
Composition and Stability of the Reagents
Specimens
Calibrators and Controls
Performance Characteristics regarding
- Measuring Range
- Specificity/Interferences
- Sensitivity/Limit of Detection
- Precision (Reproducibility, Repeatability)
- Method Comparison
Reference Ranges
Literature
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
Delay, min. time
Slope blank
Linearity Limit
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
Substr Depletion
Reagent Blank
Urea
No
25 ml
240 µl
242 µl
3.0 µl
1.0 µl
5 ml
60 µl
60 µl
24, 79 sec
No
10.0 %
-0.100 Abs
3.000 Abs
-0.100 Abs
0.3000 Abs
3.000 Abs
Yes (#)
Factor
#
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Delay, min. time
Linearity Limit
Low Absorbance
High Absorbance
R.Abs L.Limit
R.Abs H. Limit
R.Abs Deviation
Reagent blank
Urea
No
25 ml
300 µl
301 µl
Factor
#
3.0 µl
2.0 µl
12, 58 sec
10.0 %
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
0.100
Yes (#)
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are
avoided.
3.
Manufactured by
DiaSys Diagnostic Systems GmbH
Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based
on the standard equipment at that time and does not apply to
any equipment modifications undertaken by the manufacturer or
by other persons.
* can be selected freely
# calculated by the analyser
845 3101 90 02 51
September 2008/7
Aplicação de Proteína Urinária para Selectra
Proteína Total em Urina FS
Referência
Apresentação
102109910021
R1 5 x 25 ml + ST 1 x 3 ml
SELECTRA
Name
Abbr. Name
Mode
Wavelengths
Units
Decimals
Low Conc.
High Conc.
Calibrator Name
Repeat
Number
Concentration
Calibration Mode
Interval
Cut off
Prozone Check
Ref. Male Low
Ref Male High
Ref Female Low
Ref Female High
Ref Ped. Low
Ref Ped. High
Control 1
Control 2
Control 3
Correlat. Factor
Correlat. Offset
Este é um protocolo teórico e foi validado em versão de
equipamento disponível na época.
Proteína Urinária
PTU
Endpoint
600 nm
mg/dl
0
0.000 mg/dl
3000 mg/dl
Notas:
1. Por favor, recorra a bula do produto para informações
detalhadas sobre os seguintes testes:
Relevância clínica
Método e Princípio
Composição e Estabilidade dos Reagentes
Amostras
Calibradores e Controles
Desempenho e Características considerando:
- Faixa de medição
- Especificidade/Interferentes
- Sensibilidade/Limite de Detecção
- Precisão (Reprodutibilidade, Repetibilidade)
- Comparação de método
- Valores de referência
- Literatura
1
2
*
Linear
7 days
No
No
*
*
*
*
*
*
*
*
*
1.000
0.000 mg/dl
2. A estabilidade do reagente a bordo do analisador é pelo
menos e semanas contanto que sejam evitadas a
contaminação e a evaporação.
DUAL MODE
MONO MODE
Name
Sample blank
R1 bottle
normal Volume
rerun Volume
Sample
normal Volume
rerun volume
R2 bottle
normal Volume
rerun Volume
predilution
Slope blank
Point one, two
Low Absorbance
High Absorbance
R.Abs. L.Limit
R.Abs. H.Limit
Reagent blank
Cal Low limit
Cal High limit
Factor
Name
Sample blank
R1 bottle
normal volume
rerun volume
Sample
normal Volume
rerun Volume
Incubation time
Low Absorbance
High Absorbance
R.Abs.L.Limit
R.Abs. H.Limit
PTU
No
50 mL
300 µl
301 µl
Reagent blank
Cal Low limit
Cal High limit
Factor
Yes
*
*
#
6.0 µl
3.0 µl
11.5 min
-0.100 Abs
3.000 Abs
-0.100 Abs
3.000 Abs
Produzido por:
DiaSys Diagnostic Systems GmbH
Alte Strasse 9 IVD 65558 Holzheim Alemanha
Distribuído por:
Biosys Ltda.
Rua Coronel Gomes Machado, 358
Niterói – Rio de Janeiro
(21) 3907-2534
# Entrada pelo usuário
* Calibrador + salina como ponto zero.
Rev: 0 - 01/2014