TRIGLYCERIDE

TRIGLYCERIDE
7D74-20
30-3140/R3
TRIGLYCERIDE
This package insert contains information to run the Triglyceride assay on the ARCHITECT c Systems™ and the
AEROSET System.
NOTE: Changes Highlighted
NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be followed
accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in
this package insert.
Customer Support
United States:
Canada:
International:
1-877-4ABBOTT
1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
Call your local Abbott representative
Symbols in Product Labeling
Calibrators 1 and 2
Catalog number/List number
Concentration
Serial number
Authorized Representative in the
European Community
Consult instructions for use
Ingredients
Manufacturer
In vitro diagnostic medical device
Temperature limitation
Batch code/Lot number
Use by/Expiration date
Reagent 1
ABBOTT LABORATORIES
Abbott Park, IL 60064, USA
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
September 2006
©2002, 2006 Abbott Laboratories
1
NAME
REAGENT HANDLING AND STORAGE
TRIGLYCERIDE
Reagent Handling
INTENDED USE
Remove air bubbles, if present in the reagent cartridge, with a new
applicator stick. Alternatively, allow the reagent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize
volume depletion, do not use a transfer pipette to remove the bubbles.
CAUTION: Reagent bubbles may interfere with proper detection of
reagent level in the cartridge, causing insufficient reagent aspiration
which could impact results.
The Triglyceride assay is used for the quantitation of triglyceride in
human serum or plasma.
SUMMARY AND EXPLANATION OF TEST
Triglycerides are a family of lipids absorbed from the diet and produced
endogenously from carbohydrates and fatty acids. Measurement
of triglyceride is important in the diagnosis and management of
hyperlipidemia. These diseases can be genetic or secondary to
other disorders including nephrosis, diabetes mellitus, and endocrine
disturbances. The National Cholesterol Education Program (NCEP)
cites evidence that triglycerides are an independent risk factor for
atherosclerosis.1 Individuals with hypertension, obesity, and/or diabetes
are at greater risk than are those without these conditions.2,3
The Adult Treatment Panel of the NCEP recommends that all adults
20 years of age and over should have a fasting lipoprotein profile (total
cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride) once
every five years to screen for coronary heart disease risk.1
PRINCIPLES OF PROCEDURE
Triglycerides are enzymatically hydrolyzed by lipase to free fatty acids
and glycerol. The glycerol is phosphorylated by adenosine triphosphate
(ATP) with glycerol kinase (GK) to produce glycerol-3-phosphate and
adenosine diphosphate (ADP). Glycerol-3-phosphate is oxidized to
dihydroxyacetone phosphate (DAP) by glycerol phosphate oxidase
(GPO) producing hydrogen peroxide (H2O2). In a color reaction
catalyzed by peroxidase, the H2O2 reacts with 4-aminoantipyrine
(4-AAP) and 4-chlorophenol (4-CP) to produce a red colored dye. The
absorbance of this dye is proportional to the concentration of triglyceride
present in the sample. This analytical methodology is based on the
reaction sequence described by Fossati et al.4 and by McGowan et al.5
In this reagent, 4-chlorophenol is used rather than 2-hydroxy-3,5-dichlorobenzenesulfonate, used in the Fossati and McGowan studies.
Methodology: Glycerol Phosphate Oxidase
REAGENTS
Reagent Kit
7D74 Triglyceride is supplied as a liquid, ready-to-use, single
reagent kit which contains:
10 x 84 mL
Estimated tests per kit: 3,032
Calculation is based on the minimum reagent fill volume per kit.
Reactive Ingredients
ATP
Mg2+
4-Aminoantipyrine
4-Chlorophenol
Peroxidase (Horseradish)
GK (Microbial)
GPO (Microbial)
Lipoprotein Lipase (Microbial)
Concentration
2.5 mmol/L
2.5 mmol/L
0.4 mmol/L
2 mmol/L
> 2,000 U/L
> 600 U/L
> 6,000 U/L
> 3,000 U/L
Reagent Storage
Unopened reagents are stable until the expiration date when stored
at 2 to 8°C.
Reagent stability is 42 days if the reagent is uncapped and onboard.
WARNINGS AND PRECAUTIONS
Precautions for Users
1.
2.
3.
4.
For in vitro diagnostic use.
Do not use components beyond the expiration date.
Do not mix materials from different kit lot numbers.
Certain disease states may cause endogenous serum triglyceride
values to be grossly elevated. Samples that are grossly lipemic by
visual examination should be diluted prior to analysis.
5. CAUTION: This product requires the handling of human specimens.
It is recommended that all human sourced materials be considered
potentially infectious and handled in accordance with the OSHA
Standard on Bloodborne Pathogens.6 Biosafety Level 27 or other
appropriate biosafety practices8,9 should be used for materials that
contain or are suspected of containing infectious agents.
SPECIMEN COLLECTION AND HANDLING
Suitable Specimens
Serum and plasma are acceptable specimens. The National Cholesterol
Education Program (NCEP) recommends using fasting specimens.1
• Serum: Use serum collected by standard venipuncture techniques
into glass or plastic tubes with or without gel barriers. Ensure
complete clot formation has taken place prior to centrifugation.
Separate serum from red blood cells or gel as soon after collection
as possible.
Some specimens, especially those from patients receiving
anticoagulant or thrombolytic therapy, may take longer to complete
their clotting processes. Fibrin clots may subsequently form in these
sera and the clots could cause erroneous test results.
• Plasma: Use plasma collected by standard venipuncture techniques
into glass or plastic tubes. Acceptable anticoagulants are lithium
heparin (with or without gel barrier) and sodium heparin. Ensure
centrifugation is adequate to remove platelets. Separate plasma from
red blood cells or gel as soon after collection as possible.
Refer to the specimen collection tube manufacturer’s instructions for
processing and handling requirements.
For total sample volume requirements, refer to the instrument-specific
ASSAY PARAMETERS section of this package insert and Section 5 of
the instrument-specific operations manual.
2
SPECIMEN COLLECTION AND HANDLING (Continued)
QUALITY CONTROL
Specimen Storage
The following is the recommendation of Abbott Laboratories for quality
control. As appropriate, refer to your laboratory standard operating
procedure(s) and/or quality assurance plan for additional quality control
requirements and potential corrective actions.
• Two levels of controls (normal and abnormal) are to be run every
24 hours.
• If more frequent control monitoring is required, follow the established
quality control procedures for your laboratory.
• If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow
the established quality control procedures for your laboratory.
Recalibration may be necessary.
• Review quality control results and acceptance criteria following a
change of reagent or calibrator lot.
Serum and plasma
Temperature
20 to 25°C
2 to 8°C
-20°C
Maximum
Storage
2 days
7 days
> 1 year
Bibliographic
Reference
10
10, 11
10
Guder et al.10 suggest storage of frozen specimens at -20°C for
no longer than the time interval cited above. However, limitations
of laboratory equipment make it necessary in practice for clinical
laboratories to establish a range around -20°C for specimen storage.
This temperature range may be established from either the freezer
manufacturer’s specifications or your laboratory standard operating
procedure(s) for specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present,
mix and centrifuge the specimen to remove particulates prior to testing.
PROCEDURE
Materials Provided
7D74 Triglyceride Reagent Kit
Materials Required but not Provided
RESULTS
Refer to the instrument-specific operations manual for information on
results calculations.
• ARCHITECT System Operations Manual—Appendix C
• AEROSET System Operations Manual—Appendix A
Representative performance data are given in the EXPECTED VALUES
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
package insert. Results obtained in individual laboratories may vary.
LIMITATIONS OF THE PROCEDURE
•
1E65 Multiconstituent Calibrator,
3 x 5 mL
• Control Material
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC
PERFORMANCE CHARACTERISTICS sections of this package insert.
Assay Procedure
EXPECTED VALUES
For a detailed description of how to run an assay, refer to Section 5 of
the instrument-specific operations manual.
Reference Range
Serum/Plasma1
Specimen Dilution Procedures
The ARCHITECT c Systems and the AEROSET System have automatic
dilution features; refer to Section 2 of the instrument-specific operations
manual for additional information.
Serum and plasma: Specimens with triglyceride values exceeding
1,420 mg/dL (16.05 mmol/L) are flagged and may be diluted using the
Automated Dilution Protocol or the Manual Dilution Procedure.
Automated Dilution Protocol
If using the Automated Dilution Protocol, the system performs a 1:4
dilution of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor.
Manual Dilution Procedure
Manual dilutions should be performed as follows:
• Use saline (0.85% to 0.90% NaCl) to dilute the sample.
• The operator must enter the dilution factor in the patient or control
order screen. The system uses this dilution factor to automatically
correct the concentration by multiplying the result by the entered
factor.
• If the operator does not enter the dilution factor, the result must be
multiplied by the appropriate dilution factor before reporting the result.
NOTE: If a diluted sample result is flagged indicating it is less than the
linear low limit, do not report the result. Rerun using an appropriate
dilution.
For detailed information on ordering dilutions, refer to Section 5 of the
instrument-specific operations manual.
Normal
Borderline High
High
Very High
Range (mg/dL)
< 150
150 to 199
200 to 499
≥ 500
Range (mmol/L)
< 1.70
1.70 to 2.25
2.26 to 5.64
≥ 5.65
To convert results from mg/dL to mmol/L, multiply mg/dL by 0.0113.
The National Cholesterol Education Program (NCEP) Adult Treatment
Panel III Report recommends the classification shown above.
Laboratories should follow recommendations for lipid ranges effective in
their locale if they differ from those of the NCEP.
SPECIFIC PERFORMANCE CHARACTERISTICS
Linearity
Triglyceride is linear up to 1,420 mg/dL (16.05 mmol/L). Linearity was
verified using Clinical and Laboratory Standards Institute (CLSI) protocol
NCCLS EP6-P.12
Limit of Detection (LOD)
The LOD for Triglyceride is 5.0 mg/dL (0.06 mmol/L). The LOD is
the mean concentration of an analyte-free sample + 2 SD, where
SD = the pooled, within-run standard deviation of the analyte-free
sample. A study performed on an ARCHITECT c System and an
AEROSET System produced an LOD for the Triglyceride assay
of 1.00 mg/dL (0.012 mmol/L).
Limit of Quantitation (LOQ)
CALIBRATION
Calibration is stable for approximately 41 days (984 hours) and is
required with each change in reagent lot number. Verify calibration with
at least two levels of controls according to the established quality control
requirements for your laboratory. If control results fall outside acceptable
ranges, recalibration may be necessary.
For a detailed description of how to calibrate an assay, refer to Section
6 of the instrument-specific operations manual.
For information on calibrator standardization, refer to the Multiconstituent
Calibrator package insert.
3
The LOQ for Triglyceride is 6.2 mg/dL (0.071 mmol/L). The LOQ is
the analyte concentration at which the CV = 20%.
SPECIFIC PERFORMANCE CHARACTERISTICS
(Continued)
Interfering
BIBLIOGRAPHY
Substances13
Interference studies were conducted using CLSI protocol NCCLS
EP7-P.14 Interference effects were assessed by Dose Response and
Paired Difference methods, at the medical decision level of the analyte.
Interfering
Substance
Interferent Concentration
7.5 mg/dL
15 mg/dL
750 mg/dL
Hemoglobin
1,000 mg/dL
1.5 mg/dL
Ascorbate
3.0 mg/dL
Bilirubin
(128 µmol/L)
(257 µmol/L)
(7.5 g/L)
(10.0 g/L)
(85 µmol/L)
(170 µmol/L)
N
3
3
4
4
4
4
Target
Observed
(mg/dL) (% of Target)
211.0
106.6
211.0
111.3
193.1
109.6
193.1
111.2
220.4
97.0
220.4
94.0
Bilirubin solutions at the above concentrations were prepared by addition
of a bilirubin stock to human serum pools. Hemoglobin solutions at the
above concentrations were prepared by addition of hemolysate to human
serum pools. Ascorbate solutions at the above concentrations were
prepared by addition of ascorbic acid to human serum pools.
Precision
The imprecision of the Triglyceride assay is ≤ 5% Total CV.
Representative data from studies using CLSI protocol NCCLS EP5-A15
are summarized below.
Control
N
Mean (mg/dL)
Within Run
Between Run
Between Day
Total
SD
%CV
SD
%CV
SD
%CV
SD
%CV
Level 1
80
209.4
1.42
0.7
0.75
0.4
3.25
1.6
3.63
1.7
Level 2
80
100.0
0.80
0.8
0.64
0.6
1.67
1.7
1.96
2.0
Method Comparison
Correlation studies were performed using CLSI protocol NCCLS
EP9-A.16
Serum results from the Triglyceride assay on the AEROSET System
were compared with those from a commercially available glycerol
phosphate oxidase methodology.
Serum results from the Triglyceride assay on an ARCHITECT c System
were compared with the Triglyceride assay on an AEROSET System.
N
Y - Intercept
Correlation Coefficient
Slope
Range (mg/dL)*
AEROSET
vs. Comparative
Method
76
0.311
0.994
1.048
ARCHITECT
vs. AEROSET
36.1 to 990.6
37.60 to 1,370.40
91
5.858
0.999
0.989
1. Executive summary of the third report of the National Cholesterol
Education Program (NCEP) Expert Panel on detection, evaluation,
and treatment of high blood cholesterol in adults (Adult Treatment
Panel III). JAMA 2001;285:2486–97.
2. Rubins HB. Triglycerides and coronary heart disease: implications
of recent clinical trials. J Cardiovasc Risk 2000;7(5):339–45.
3. Forrester JS. Triglycerides: risk factor or fellow traveler? Curr Opin
Cardiol 2001;16:261–4.
4. Fossati P, Prencipe L. Serum triglycerides determined
colorimetrically with an enzyme that produces hydrogen peroxide.
Clin Chem 1982;28:2077–80.
5. McGowan MW, Artiss JD, Strandbergh DR, et al. A
peroxidase-coupled method for the colorimetric determination of
serum triglycerides. Clin Chem 1983;29:538–42.
6. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030, Occupational exposure to
bloodborne pathogens.
7. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories. HHS Publication
(CDC), 4th ed. Washington, DC: US Government Printing Office,
May 1999.
8. World Health Organization. Laboratory Biosafety Manual. Geneva:
World Health Organization, 2004.
9. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved
Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
Laboratory Standards Institute, 2005.
10. Guder WG, Narayanan S, Wisser H, et al. List of
analytes—preanalytical variables. Annex In: Samples: From
the Patient to the Laboratory. Darmstadt, Germany: GIT Verlag;
1996:Annex 22–3.
11. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
12. Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity
of Quantitative Analytical Methods; Proposed Guideline (EP6-P).
Villanova, PA: The National Committee for Clinical Laboratory
Standards, 1986.
13. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Washington, DC: AACC Press; 1995:3-573–3-589.
14. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in
Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The
National Committee for Clinical Laboratory Standards, 1986.
15. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Performance of Clinical Chemistry Devices; Approved Guideline
(EP5-A). Wayne, PA: The National Committee for Clinical
Laboratory Standards, 1999.
16. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison
and Bias Estimation Using Patient Samples; Approved Guideline
(EP9-A). Wayne, PA: The National Committee for Clinical
Laboratory Standards, 1995.
TRADEMARKS
AEROSET and ARCHITECT are registered trademarks of Abbott
Laboratories.
c System is a trademark of Abbott Laboratories.
All other trademarks, brands, product names, and trade names are the
property of their respective companies.
*AEROSET Range
4
ARCHITECT c SYSTEMS ASSAY PARAMETERS
Triglyceride Serum/Plasma—Conventional and SI Units
Configure assay parameters — General
● General
Configure assay parameters — SmartWash
о Calibration о SmartWash о Results
о Interpretation
о General о Calibration ● SmartWash о Results о Interpretation
Assay:
Trig
COMPONENT REAGENT / ASSAY WASH
Volume Replicates
Cuvette
Trig
10% Detergent B*** 345
Assay: Trig
Type: Photometric
Version: 1
Number: 1017
● Reaction definition о Reagent / Sample о Validity checks
Reaction mode: End up
Primary Secondary
Read times
Wavelength: 500 / 660
Main: 15 – 17
Last required read: 17
Absorbance range: ___ – ___
Color correction: ___ – ___
Sample blank type: None
о Reaction definition
Reagent: TRIG0
Diluent: Saline
Diluent dispense mode: Type 0
Diluted
Dilution name Sample sample
STANDARD : 2.4
___
1:4
: 25.0
2.4
__________ : ___
___
*** Select “Detergent B” for software prior to version 2.2.
Triglyceride Serum/Plasma—Conventional Units
Configure assay parameters — Results
● Reagent / Sample о Validity checks
Reagent volume:
Water volume:
Dispense mode:
Diluent
___
75
___
Water Dilution factor
___ =
1:1.00
___ =
1:4.00
___ =
о Reaction definition о Reagent / Sample
Reaction check:
End Subtraction
о General
о SmartWash ● Results о Interpretation
Assay: Trig
Result units: mg/dL
Assay defaults:
Low-Linearity:
7†
High-Linearity: 1420
Gender and age specific ranges:
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0 – 149
R1
240
___
Type 0
Default
dilution
●
о
о
● Validity checks
Read time:
Calculation limits:
Maximum absorbance variation: 0.0100
о Calibration
Configure result units
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
A
B
9–9
11 – 11
- 0.1000 – 0.1000
Trig
1
mg/dL
0
[Range 0 – 4]
1.0000
0.0000
Configure assay parameters — Calibration
о General
Assay:
● Calibration о SmartWash о Results
Trig
● Calibrators
о Volumes
Calibrator set:
MCC
Replicates: 3
о Calibrators
Calibrator: MCC
Blank:
Cal 1:
Cal 2:
[Range 1 – 3]
о Intervals
Calibrator level:
Blank: Water
Cal 1: MCC1
Cal 2: MCC2
● Volumes
Calibrator level
Water
MCC1
MCC2
о Calibrators
о Volumes
Calibration intervals:
Full interval: 984
Calibration type:
Adjust type: None
о Calibrators
о Interpretation
Triglyceride Serum/Plasma—SI Units
Calibration method: Linear
о Volumes
Blank absorbance range:
Span:
Span absorbance range:
Expected cal factor:
Expected cal factor tolerance %:
о Intervals
Sample
2.4
2.4
2.4
Diluted
sample
___
___
___
● Intervals
Configure assay parameters — Results
о Validity checks
о General
о SmartWash ● Results о Interpretation
Assay: Trig
Result units: mmol/L
Assay defaults:
Low-Linearity:
0.08†
High-Linearity: 16.05
Gender and age specific ranges:*
GENDER
AGE (UNITS)
NORMAL
EXTREME
Either
0 – 130 (Y)
0.00 – 1.69
Concentration:
0††
‡
‡
о Validity checks
Diluent
___
___
___
Water
___
___
___
Configure result units
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о Validity checks
(hours)
о Intervals
_____ – _____
Blank – Blank
_____ – _____
0.00
0
о Calibration
Trig
1
mmol/L
2
[Range 0 – 4]
1.0000
0.0000
● Validity checks
† The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
‡ Refer to concentration specified on calibrator labeling or value sheet.
†† Displays the number of decimal places defined in the decimal places parameter field.
5
AEROSET SYSTEM ASSAY PARAMETERS
Triglyceride Serum/Plasma—Conventional Units
Triglyceride Serum/Plasma—SI Units
Assay Configuration: Outline Page
Assay Name
Assay #
Trig
17
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
7**
Reference Ranges*
Age
L-Reference-H
0
149
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
Qualitative Ranges
Assay Configuration: Outline Page
Line
B-Line
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
0.0
1420
0.0
0.0
0.0
0.0
Max
0.0*
Assay Name
Assay #
Trig
17
Quantitative Ranges
Min Text
Min Panic-L
*
0.0*
0.0
0.08**
Reference Ranges*
Age
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
Line
B-Line
L-Reference-H
0.00
1.69
L-Linear Range-H
0.0
0.0
0.0
0.0
0 Year
0 Year
0 Year
N/A
Qualitative Ranges
Male
–
–
–
–
0.0
0.0
0.0
0.0
Panic-H
Max
0.0
0.0*
16.05
0.0
0.0
0.0
0.0
Max Text
*
Female
– 0.0
– 0.0
– 0.0
– 0.0
N/A
Assay Configuration: Base Page
Assay Configuration: Base Page
Reaction Mode
Wavelength-Prim/Sec Read time-Main/Flex
AbsMaxVar
END UP
500 / 660
15 – 17 / 0 – 0
0.01
Sample Blank Test
Blank Read Time Abs Window
Abs Limits
_____ ( ___ )
0–0
0–0
0.0 – 0.0
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.4
0.0
0
0
Rgt Name/Pos
Dil 1
25.0
2.4
75
0
Diluent: DILUENT D–18*
Dil 2
2.4
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
TRIG061 – ___*
240
0
0
Reaction Check
Read Time – A/B
Range
Minimum
END SUB
9 – 9 / 11 – 11
-0.1 – 0.1
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
0
mg/dL
Reaction Mode
Wavelength-Prim/Sec Read time-Main/Flex
AbsMaxVar
END UP
500 / 660
15 – 17 / 0 – 0
0.01
Sample Blank Test
Blank Read Time Abs Window
Abs Limits
_____ ( ___ )
0–0
0–0
0.0 – 0.0
S.Vol
DS.Vol
D.Vol W.Vol
Standard
2.4
0.0
0
0
Rgt Name/Pos
Dil 1
25.0
2.4
75
0
Diluent: DILUENT D–18*
Dil 2
2.4
0.0
0
0
Type#
0
Rgt Name/Pos
R.Vol W.Vol Type#
Reagent 1
TRIG061 – ___*
240
0
0
Reaction Check
Read Time – A/B
Range
Minimum
END SUB
9 – 9 / 11 – 11
-0.1 – 0.1
0.0
Factor/Intercept
Decimal Places
Units
1.0 / 0.0
2
mmol/L
Assay Configuration: Calibration Page
Calib Mode
Linear
Blank/Calib Replicates
3/3
Sample
S.Vol
BLK Water
2.4
C1
MCC 1
2.4
C2
MCC 2
2.4
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
0.0
0
Assay Configuration: Calibration Page
Interval (H)
984
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0
0.0
FAC Limit (%)
10
Calib Mode
Linear
Blank/Calib Replicates
3/3
Sample
S.Vol
BLK Water
2.4
C1
MCC 1
2.4
C2
MCC 2
2.4
Assay Configuration: SmartWash Page
Extrapolation %
0
DS.Vol
D.Vol
0.0
0
0.0
0
0.0
0
Interval (H)
984
Span
Span Abs Range
BLK – 1
0.0 – 0.0
W.Vol
Blk Abs Range
0
0.0 – 0.0
0
Cal Deviation
0
0.0
FAC Limit (%)
10
Assay Configuration: SmartWash Page
Rgt Probe
Rgt Probe
Reagent
—
Wash
—
Vol
—
Assay Name
—
Wash
—
Vol
—
Cuvette
Reagent
—
Wash
—
Vol
—
Assay Name
—
Wash
—
Vol
—
Cuvette
Sample Probe
Sample Probe
Wash
—
Wash
—
Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** The linear low value (L-Linear Range) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
6
7
8