INSTRUCTIONS FOR USE
TRIG
Triglyceride
For Coatings 3400 and Above
VITROS Chemistry Products TRIG Slides
133 6544
832 9930
Rx ONLY
Intended Use
For in vitro diagnostic use only.
VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma
using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Triglyceride
measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other
diseases involving lipid metabolism, or various endocrine disorders.
Summary and Explanation of the Test
Triglycerides, fatty acid esters of glycerol, represent the major form of fat found in the body; their primary function is to store
and provide cellular energy. The concentration of triglycerides in the plasma at any given time is a balance between the
rates of entry and removal. Triglyceride concentrations in the plasma vary with age and gender. Moderate increases occur
during growth and development. Triglycerides are used for the evaluation of hyperlipidemias; high concentrations may
occur with hypothyroidism, nephrotic syndrome, glycogen storage diseases, and diabetes mellitus. Extremely high
triglyceride concentrations are common in acute pancreatitis. 1
Principles of the Procedure
The VITROS TRIG Slide method is performed using the VITROS TRIG Slides and the VITROS Chemistry Products
Calibrator Kit 2 on VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
The VITROS TRIG Slide is a multilayered, analytical element coated on a polyester support. The analysis is based on an
enzymatic method as described by Spayd et al. 2
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers.
The Triton X-100 surfactant in the spreading layer aids in dissociating the triglycerides from lipoprotein complexes present
in the sample. The triglyceride molecules are then hydrolyzed by lipase to yield glycerol and fatty acids. Glycerol diffuses to
the reagent layer, where it is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP). In the
presence of L-α-glycerol-phosphate oxidase, L-α-glycerophosphate is then oxidized to dihydroxyacetone phosphate and
hydrogen peroxide. The final reaction involves the oxidation of a leuco dye by hydrogen peroxide, catalyzed by peroxidase,
to produce a dye.
The density of the dye formed is proportional to the triglyceride concentration present in the sample and is measured by
reflectance spectrophotometry.
Test Type and Conditions
Test Type
Colorimetric
VITROS System
5600, 4600,
5,1 FS, 950,
250/350
Approximate
Incubation Time
5 minutes
Temperature
Wavelength
Reaction Sample
Volume
37 °C (98.6 °F)
540 nm
5.5 µL
Not all products and systems are available in all countries.
Version 2.0
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TRIG
INSTRUCTIONS FOR USE
Triglyceride For Coatings 3400 and Above
Warnings and Precautions
Reaction Scheme
surfactant
lipoproteins
triglycerides + proteins
lipase
triglycerides + H2O
glycerol kinase
MgCl2
glycerol + ATP
L-α-glycerophosphate + O2
L-α-glycerophosphate + ADP
L-α-glycerol-phosphate oxidase
peroxidase
H2O2 + leuco dye
glycerol + fatty acids
dihydroxyacetone phosphate + H2O2
dye + 2H2O
Warnings and Precautions
For in vitro diagnostic use only.
WARNING:
Take care when handling materials and samples of human origin. Since no test
method can offer complete assurance that infectious agents are absent, consider
all clinical specimens, controls, and calibrators potentially infectious. Handle
specimens, solid and liquid waste, and test components in accordance with local
regulations and CLSI Guideline M29 3 or other published biohazard safety
guidelines.
For specific warnings and precautions for calibrators, quality control materials, and other components, refer to the
Instructions for Use for the appropriate VITROS product, or to other manufacturer’s product literature.
Reagents
Slide Diagram
Slide Ingredients
Reactive Ingredients per cm2
Lipase (Pseudomonas sp., E.C.3.1.1.3) 0.08 U; peroxidase
(horseradish root, E.C.1.11.1.7) 0.52 U; glycerol kinase
(Cellulomonas sp., E.C.2.7.1.30) 0.35 U; L-α-glycerophosphate
oxidase (Pediococcus sp., E.C.1.1.3.21) 0.19 U; Triton X-100
0.62 mg; 2-(3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis(4dimethylaminophenyl) imidazole (leuco dye) 0.04 mg; and
adenosine triphosphate 0.14 mg.
1. Upper slide mount
2. Spreading layer (TiO2)
• Triton X-100
• lipase
3. Reagent layer
•
•
•
•
•
•
buffer, pH 8.0
glycerol kinase
ATP
L-α-glycerophosphate oxidase
peroxidase
leuco dye
4. Support Layer
5. Lower slide mount
Other Ingredients
Pigment, binders, buffer, surfactants, stabilizers, scavenger,
enzyme cofactors, dye solubilizer and cross-linking agent.
Reagent Handling
Caution:
•
•
Do not use slide cartridges with damaged or incompletely sealed packaging.
Inspect the packaging for signs of damage.
Be careful when opening the outer packaging with a sharp instrument so as to avoid damage to the individual product
packaging.
Reagent Preparation
IMPORTANT:
The slide cartridge must reach room temperature, 18–28 °C (64–82 °F), before it is
unwrapped and loaded into the slide supply.
1. Remove the slide cartridges from storage.
2. Warm the wrapped cartridge at room temperature for 60 minutes.
3. Unwrap and load the cartridge into the slide supply.
Note:
2 of 12
Load the cartridges within 24 hours after they reach room temperature, 18–28 °C
(64–82 °F).
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INSTRUCTIONS FOR USE
TRIG
Reagent Storage and Stability
Triglyceride For Coatings 3400 and Above
Reagent Storage and Stability
VITROS TRIG Slides are stable until the expiration date on the carton when they are stored and handled as specified. Do
not use beyond the expiration date.
Reagent
Unopened
Opened
Frozen
On-analyzer
On-analyzer
Storage Condition
≤-18 °C (≤0 °F)
System turned on
System turned off
Stability
Until expiration date
≤ 1 week
≤ 2 hours
Verify performance with quality control materials:
• If the system is turned off for more than 2 hours.
• After reloading cartridges that have been removed from the slide supply and stored for later use.
Specimen Collection, Preparation and Storage
Specimens Recommended
• Serum
• Plasma: Heparin (Lithium and Sodium)
Serum is the specimen of choice because it is the basis for the US National Institutes of Health recommendations relating
lipid levels with cardiac risk. Heparin plasma results have been reported as being within 1% of serum results. 4
IMPORTANT:
Certain collection devices have been reported to affect other analytes and tests. 5
Owing to the variety of specimen collection devices available, Ortho-Clinical
Diagnostics is unable to provide a definitive statement on the performance of its
products with these devices. Confirm that your collection devices are compatible
with this test.
Specimens Not Recommended
Plasma: EDTA 4
Serum and Plasma
Specimen Collection and Preparation
Collect specimens using standard laboratory procedures. 6,
Note:
7
For details on minimum fill volume requirements, refer to the operating
instructions for your system.
Patient Preparation
No special patient preparation is necessary.
Special Precautions
• Equipment must be soap-free and glycerol-free.
• Do not use collection tubes with glycerol-lubricated stoppers.
• Centrifuge specimens and remove the serum or plasma from the cellular material within 4 hours of collection. 9
Specimen Handling and Storage
•
•
Handle and store specimens in stoppered containers to avoid contamination and evaporation.
Mix samples by gentle inversion and bring to room temperature, 18–28 °C (64–82 °F), prior to analysis.
Specimen Storage and Stability 9
Storage
Room Temperature
Refrigerated
Frozen
IMPORTANT:
Version 2.0
Temperature
18–28 °C (64–82 °F)
2–8 °C (36–46 °F)
≤-18 °C (≤0 °F)
Stability
≤ 3 days
≤ 7 days
≤ 6 months
Avoid repeated freeze-thaw cycles.
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TRIG
INSTRUCTIONS FOR USE
Triglyceride For Coatings 3400 and Above
Testing Procedure
Testing Procedure
Materials Provided
VITROS Chemistry Products TRIG Slides
Materials Required but Not Provided
•
•
•
•
VITROS Chemistry Products Calibrator Kit 2
Quality control materials, such as VITROS Chemistry Products Performance Verifier I and II
VITROS Chemistry Products 7% BSA (manual dilution)
VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline) [chamber D2 (BSA) for on-analyzer dilution]
Operating Instructions
•
•
Check reagent inventories at least daily to ensure that quantities are sufficient for the planned workload.
For additional information, refer to the operating instructions for your system.
IMPORTANT:
Bring all fluids and samples to room temperature, 18–28 °C (64–82 °F), prior to
analysis.
Sample Dilution
Serum and Plasma
If samples are grossly lipemic or show triglyceride concentrations that exceed the system’s measuring (reportable or
dynamic) range:
Manual Sample Dilution
1. Dilute the sample with VITROS 7% BSA.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample’s triglyceride concentration.
On-Analyzer Sample Dilution (VITROS 5600 Integrated, VITROS 5,1 FS/4600 and VITROS 250/350 Systems only)
Refer to the operating instructions for your system for more information on the On-Analyzer Dilution Procedure. For
VITROS 5600 Integrated and VITROS 5,1 FS/4600 Chemistry Systems, use VITROS Chemistry Products FS Diluent Pack
2 for the dilution.
Calibration
Required Calibrators
VITROS Chemistry Products Calibrator Kit 2
Calibrator Preparation, Handling, and Storage
Refer to the Instructions for Use for VITROS Calibrator Kit 2.
Calibration Procedure
Refer to the operating instructions for your system.
When to Calibrate
Calibrate:
• When the slide lot number changes.
• When critical system parts are replaced due to service or maintenance.
• When government regulations require.
For example, in the USA, CLIA regulations require calibration or calibration verification at least once every six months.
The VITROS TRIG test may also need to be calibrated:
• If quality control results are consistently outside acceptable range.
• After certain service procedures have been performed.
For additional information, refer to the operating instructions for your system.
Calculations
Reflectance from the slide is measured at 540 nm after the fixed incubation time. Once a calibration has been performed for
each slide lot, triglyceride concentration in unknown samples can be determined using the software-resident endpoint
colorimetric math model and the response obtained from each unknown test slide.
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INSTRUCTIONS FOR USE
TRIG
Quality Control
Triglyceride For Coatings 3400 and Above
Validity of a Calibration
Calibration parameters are automatically assessed by the system against a set of quality parameters detailed in the
Coefficients and Limits screen on VITROS 250/350/950 Systems (on the VITROS 5600 Integrated and VITROS 5,1 FS/
4600 Systems, see the Review Assay Data screen). Failure to meet any of the pre-defined quality parameters results in a
failed calibration. The calibration report should be used in conjunction with quality control results to determine the validity of
a calibration.
Measuring (Reportable or Dynamic) Range
Conventional Units
(mg/dL)
10.0–525.0
SI Units
(mmol/L)
0.11–5.93
Alternate Units
(g/L)
0.10–5.25
For out-of-range samples, refer to “Sample Dilution.”
Traceability of Calibration
Values assigned to the VITROS Chemistry Products Calibrator Kit 2 for triglyceride are traceable to the Certified NIST
(National Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 1951. The
Ortho Clinical Diagnostics calibration laboratory uses SRM® 1951 to calibrate a glycerol phosphate oxidase (GPO)
triglyceride spectrophotometric method 11 to support triglyceride value assignment for VITROS Calibrator Kit 2.
Quality Control
Quality Control Material Selection
IMPORTANT:
•
•
VITROS Performance Verifiers are recommended for use with the VITROS
Chemistry and Integrated Systems. Evaluate the performance of other commercial
control fluids for compatibility with this test before using for quality control.
Control materials other than VITROS Performance Verifiers may show a difference when compared with other
triglyceride methods if they:
– Depart from a true human matrix.
– Contain high concentrations of preservatives, stabilizers, or other nonphysiological additives.
Do not use control materials stabilized with ethylene glycol.
Quality Control Procedure Recommendations
•
•
•
•
•
•
Choose control levels that check the clinically relevant range.
Analyze quality control materials in the same manner as patient samples, before or during patient sample processing.
To verify system performance, analyze control materials:
– After calibration.
– According to local regulations or at least once each day that the test is being performed.
– After specified service procedures are performed. Refer to the operating instructions for your system.
If control results fall outside your acceptable range, investigate the cause before deciding whether to report patient
results.
For general quality control recommendations, refer to Statistical Quality Control for Quantitative Measurements:
Principles and Definitions; Approved Guideline–Third Edition 12 or other published guidelines.
For additional information, refer to the operating instructions for your system.
Quality Control Material Preparation, Handling, and Storage
Refer to the Instructions for Use for VITROS Chemistry Products Performance Verifier I and II or to other manufacturer's
product literature.
Results
Reporting Units and Unit Conversion
The VITROS Chemistry and Integrated Systems may be programmed to report TRIG results in conventional, SI, and
alternate units.
Conventional Units
mg/dL
Version 2.0
SI Units
mmol/L (mg/dL × 0.01129)
Pub. No. J40115_EN
Alternate Units
g/L (mg/dL × 0.01)
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TRIG
INSTRUCTIONS FOR USE
Triglyceride For Coatings 3400 and Above
Limitations of the Procedure
Limitations of the Procedure
Known Interferences
The VITROS Chemistry Products TRIG Slide method was screened for interfering substances following CLSI Protocol
EP7-A2. 13 The substances listed in Tables 1 and 2, when tested in serum at the concentrations indicated, caused the bias
shown. Interferent claims were cited whenever the maximum bias became equal to or exceeded the specificity requirement
for TRIG. Materials exhibiting biases less than the specificity requirement have been cited as substances that do not
interfere. It is possible that other interfering substances may be encountered. These results are representative; however,
your results may differ somewhat due to test-to-test variation. The degree of interference at concentrations other than those
listed might not be predictable.
Table 1 – Known Interferences: Lowest Interfering Concentration Levels
Interferent
Ethamsylate
Hydroxyurea
L-Dopa
Lowest Interfering
Concentration*
Triglyceride
Concentration
Triglyceride Bias
Conv.
(mg/dL)
SI
(mmol/L)
Conv.
(mg/dL)
SI
(mmol/L)
Conv.
(mg/dL)
SI
(mmol/L)
6.8
0.26
149
1.68
-12.0
-0.14
9.8
0.37
443
5.00
-35.4
-0.40
27.2
3.56
154
1.74
-12.3
-0.14
16.2
2.12
477
5.39
-38.2
-0.43
2.0
0.10
142
1.60
-12.0
-0.14
3.7
0.19
456
5.15
-36.5
-0.41
*
The lowest interfering concentration of each substance was determined using the maximum 95% confidence interval of the quadratic
regression that met or exceeded the specificity requirement (+/-12 mg/dL at triglyceride concentrations at or below 150 mg/dL and +/8% at triglyceride concentrations above 150 mg/dL).
Table 2 – Known Interferences: Interference at Upper Therapeutic Concentration Level
Interferent
Ethamsylate
Hydroxyurea
L-Dopa
*
•
•
•
Upper Therapeutic
Concentration
Conv.
(mg/dL)
SI
(mmol/L)
25
0.95
65
12
8.51
0.60
Triglyceride Concentration
Triglyceride Bias at Upper
Therapeutic Concentration*
Conv.
(mg/dL)
SI
(mmol/L)
Conv.
(mg/dL)
SI
(mmol/L)
141
1.59
-32
-0.36
465
5.25
-98
-1.11
152
1.72
-26
-0.29
485
5.48
-116
-1.31
140
1.58
-30
-0.34
452
5.10
-92
-1.04
The bias is the maximum 95% confidence interval for the largest mean difference observed at the upper therapeutic concentration.
Free glycerol 14
Free glycerol in serum is measured along with the glycerol from the hydrolysis of triglycerides and diglycerides. Certain
clinical conditions show high endogenous free glycerol levels. Some drugs are also known to produce elevated glycerol
levels in serum. Triglyceride results from samples of such patients will not reflect actual serum triglyceride content.
Grossly lipemic samples show a slower rate of color development than do clear serums, which results in a negative bias.
These samples often contain triglyceride concentrations greater than the system’s measuring (reportable or dynamic)
range. Grossly lipemic samples should be diluted prior to testing.
For substances that were tested and did not interfere, refer to “Specificity.”
Other Limitations
Certain drugs and clinical conditions are known to alter triglyceride concentration in vivo. For additional information, refer to
one of the published summaries. 15, 16
Expected Values
Classification
Triglyceride levels are categorized according to the classification scheme in the ATP III guidelines recommended by NCEP
for samples collected from fasting patients. 8
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INSTRUCTIONS FOR USE
TRIG
Performance Characteristics
Classification
Normal
Borderline High
High
Very High
Triglyceride For Coatings 3400 and Above
Conventional Units
(mg/dL)
< 150
150–199
200–499
≥ 500
SI Units
(mmol/L)
< 1.69
1.69–2.25
2.26–5.64
≥ 5.65
Alternate Units
(g/L)
< 1.50
1.50–1.99
2.00–4.99
≥ 5.00
Performance Characteristics
Limit of Detection
The limit of detection (LoD) for the VITROS Triglyceride test using delipidized human serum pools is 3.8 mg/dL, with
proportions of false positives (α) less than 1% and false negatives (β) less than 1% based on 1100 determinations with 100
blanks and 1000 low-level samples. The Limit of Blank (LoB) is 2.0 mg/dL and the Limit of Quantitation (LoQ) is 3.8 mg/dL
as determined by the lowest concentration at which precision and accuracy design requirements are met. The LoB, LoD
and LoQ were verified consistent with NCCLS document EP17-A 10. The data presented are a representation of product
performance.
LoB*
LoD**
LoQ***
(mg/dL)
(mg/dL)
(mg/dL)
2.0
3.8
3.8
*
Limit of Blank, or the highest value likely to be observed with a sample containing no analyte with 95% level of confidence that it does
not contain the analyte of interest.
**
Limit of Detection, The minimum amount of analyte whose presence can be detected with 99% level of confidence under defined
conditions.
*** Limit of Quantitation, The minimum amount of analyte whose presence can be quantitatively determined with stated acceptable
precision and trueness.
Method Comparison
The plots and data below show the results of a method comparison study with serum samples analyzed on the VITROS 5,1
FS Chemistry System and an Enzymatic Total Glycerol method traceable to Certified NIST (National Institute of Standards
and Technology) Reference Material, SRM® (Standard Reference Material) 1951, based on Clinical Laboratory Standards
Institute (CLSI) Protocol EP9-A2 18
The table also shows the results of comparisons with serum samples on the VITROS 950 Chemistry System, the VITROS
350 Chemistry System, and the VITROS 5600 Integrated System against the VITROS 5,1 FS Chemistry System. This
testing followed CLSI Protocol EP9-A2. 18
Conventional Units
VITROS 5,1 FS Chemistry System (mg/dL)
VITROS 5,1 FS Chemistry System (mmol/L)
SI Units
Comparative Method: Enzymatic Total Glycerol
(mg/dL)
Version 2.0
Pub. No. J40115_EN
Comparative Method: Enzymatic Total Glycerol
(mmol/L)
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TRIG
INSTRUCTIONS FOR USE
Triglyceride For Coatings 3400 and Above
Performance Characteristics
Conventional Units (mg/dL)
n
Slope
VITROS 5,1 FS vs.
comparative method*
119
0.99
0.999
11–503
-1.36
5.13
0.12–5.68
-0.02
0.06
VITROS 950 vs.
VITROS 5,1 FS
119
1.00
1.000
12–494
+1.78
1.96
0.14–5.58
+0.02
0.02
VITROS 350 vs.
VITROS 5,1 FS
119
0.99
1.000
12–494
+3.21
2.05
0.14–5.58
+0.04
0.02
VITROS 5600 vs.
VITROS 5,1 FS
120
1.00
1.000
15–524
-0.20
2.03
0.17–5.92
0.00
0.02
System
*
Range of
Sample Conc.
Intercept
SI Units (mmol/L)
Correlation
Coefficient
Sy.x
Range of
Sample Conc.
Intercept
Sy.x
Enzymatic Total Glycerol
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same
specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been
demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are
therefore applicable to the VITROS 4600 System.
Precision
Precision was evaluated with quality control materials on VITROS 350, 950, 5,1 FS Chemistry Systems and the VITROS
5600 Integrated System following NCCLS protocol EP5-A2 20
The data presented are a representation of test performance and are provided as a guideline. Variables such as sample
handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect
reproducibility of assay results.
Conventional Units (mg/dL)
System
VITROS 350
VITROS 950
VITROS 5,1 FS
VITROS 5600
*
SI Units (mmol/L)
Within Lab Within Lab
CV%**
SD**
Mean
Conc.
Within
Day SD*
Within Lab
SD**
Mean
Conc.
Within
Day SD*
106
1.0
1.5
1.20
0.01
0.02
1.4
88
22
237
2.5
3.0
2.68
0.03
0.03
1.3
88
22
464
4.6
7.9
5.24
0.05
0.09
1.7
88
22
No.
Observ.
No. Days
105
1.1
1.3
1.19
0.01
0.01
1.2
88
22
237
2.6
2.8
2.68
0.03
0.03
1.2
88
22
468
4.6
4.8
5.28
0.05
0.05
1.0
88
22
104
1.0
1.1
1.17
0.01
0.01
1.1
88
22
236
2.1
2.1
2.66
0.02
0.02
0.9
88
22
464
5.2
6.7
5.24
0.06
0.08
1.4
88
22
105
1.0
2.1
1.19
0.01
0.02
2.0
84
21
238
1.9
4.3
2.69
0.02
0.05
1.8
84
21
468
4.8
6.2
5.28
0.05
0.07
1.3
84
21
Within Day precision was determined using two runs per day with two replications per run.
**
Within Lab precision was determined using a single lot of slides and calibrating weekly.
Analytical processing hardware and software algorithms on the VITROS 4600 Chemistry System are designed to the same
specifications as those applied to the VITROS 5,1 FS Chemistry System. Assay performance on the VITROS 4600 System has been
demonstrated to be comparable to that on the VITROS 5,1 FS System. All performance characteristics for VITROS 5,1 FS System are
therefore applicable to the VITROS 4600 System.
Specificity
Substances that Do Not Interfere
The substances listed in the table were tested with the VITROS TRIG Slides according to CLSI Protocol EP7-A2, 13 and
found not to interfere at the concentrations shown. The substances were tested at a triglyceride concentration of
approximately 150 mg/dL (1.69 mmol/L) and found not to interfere, bias <12 mg/dL (0.14 mmol/L). The substances were
also tested at a triglyceride concentration of approximately 500 mg/dL (5.65 mmol/L) and found not to interfere, bias <8%.
Compound
Concentration
Acetaminophen
Acetylsalicylic acid
Alprazolam
1324 µmol/L
65.2 mg/dL
3.62 mmol/L
0.2 mg/dL
6.48 µmol/L
79.4 mg/dL
5.22 mmol/L
Amitriptyline
1.001 µg/mL
3.61 µmol/L
Amlodipine
0.01 mg/dL
245 nmol/L
Para-Aminosalicylic acid
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20.01 mg/dL
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INSTRUCTIONS FOR USE
TRIG
Performance Characteristics
Triglyceride For Coatings 3400 and Above
Compound
Concentration
Amoxicillin
7.53 mg/dL
206 µmol/L
Ascorbic acid
6.02 mg/dL
342 µmol/L
Atorvastatin
600 µg/L
519 nmol/L
Azithromycin
1.15 mg/dL
15.3 µmol/L
Bilirubin, conjugated
38.9 mg/dL
462 µmol/L
Bilirubin, unconjugated
27 mg/dL
462 µmol/L
Carbenicillin
200 mg/dL
5.31 mmol/L
Cephalexin
11.7 mg/dL
337 µmol/L
Cholesterol*
503 mg/dL
13 mmol/L
1 mg/dL
30.2 µmol/L
0.01 µg/mL
43.5 nmol/L
18 mg/dL
560 µmol/L
7 mg/dL
291 µmol/L
Ciprofloxacin
Clonidine
Clopidogrel
Cystine
Diatrizoate, sodium (Hypaque®)
521 mg/dL
8.2 mmol/L
Dipyrone
120 mg/dL
3.6 mmol/L
0.899 µg/mL
5.87 µmol/L
Dopamine
Estradiol
1.2 ng/mL
4.41 nmol/L
Ethanol
400 mg/dL
86.8 mmol/L
Fenofibrate
4.5 mg/dL
125 µmol/L
Furosemide
6 mg/dL
181 µmol/L
1.79 mg/dL
117 µmol/L
Gentisic acid
92 mg/dL
3 mmol/L
Glyburide
Glutathione
1.92 µg/mL
3.89 µmol/L
Hemoglobin
600 mg/dL
6 g/L
Hydrochlorothiazide
0.6 mg/dL
20.2 µmol/L
Hydrocodone
Ibuprofen
Insulin
Isoniazid
0.67 µmol/L
2425 µmol/L
300 µIU/mL
1986.8 pmol/L
4 mg/dL
292 µmol/L
0.1 mg/dL
1.29 µmol/L
0.03 mg/dL
0.74 µmol/L
4 mg/dL
310 µmol/L
24.02 mg/dL
597 µmol/L
Methimazole
1.2 mg/dL
105 µmol/L
Methotrexate
91 mg/dL
2 mmol/L
Methyldopa
1.5 mg/dL
71 µmol/L
Levothyroxine
Lisinopril
Metformin
Methicillin sodium
Metoprolol
0.5 mg/dL
18.7 µmol/L
49.75 mg/dL
2170 µmol/L
Niacin
40 mg/dL
3.25 mmol/L
Omega-3 Fatty Acid, DHA (docosahexaenoic acid)
90 mg/dL
2.74 mmol/L
Omega-3 Fatty Acid, EPA (eicosapentaenoic acid)
111.6 mg/dL
3.69 mmol/L
Naproxen
Version 2.0
0.02 mg/dL
50.02 mg/dL
Omeprazole
0.6 mg/dL
17.4 µmol/L
Phospholipids
852 mg/dL
11.1 mmol/L
Pioglitazone
2.7 mg/dL
76 µmol/L
Prednisone
0.03 mg/dL
0.84 µmol/L
Rifampin
6.43 mg/dL
78.1 µmol/L
Sertraline
0.06 mg/dL
1.96 µmol/L
Sitagliptin
5.22 mg/dL
128.2 µmol/L
Terazosin
3.02 µg/mL
7.8 µmol/L
Total protein
10 g/dL
100 g/L
Triamterene
0.89 mg/dL
35 µmol/L
Pub. No. J40115_EN
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INSTRUCTIONS FOR USE
TRIG
Triglyceride For Coatings 3400 and Above
References
Compound
Concentration
L-Tyrosine
72.48 mg/dL
4000 µmol/L
Warfarin
10.02 µg/mL
32.5 µmol/L
*
Cholesterol was evaluated using patient samples with TRIG concentrations of 57–446 mg/dL (0.64–5.04 mmol/L)
References
1.
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Tietz NW (ed). Fundamentals of Clinical Chemistry. ed. 3. Philadelphia: WB Saunders; 452–453; 1987.
Spayd R, et al. Multilayer Film Elements for Clinical Analysis. Clin. Chem. 24:1348–1350; 1978.
CLSI. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline – Third Edition.
CLSI document M29-A3 (ISBN 1-56238-567-4). CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898
USA; 2005.
NCEP. Recommendations for improving cholesterol measurement. A report from the Laboratory Standardization Panel
of the National Cholesterol Education Program. NIH publication no. 90-2964:26–27; 1990.
Calam RR. Specimen Processing Separator Gels: An Update. J Clin Immunoassay. 11:86-90; 1988.
CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Sixth
Edition. CLSI document H3-A6 (ISBN 1-56238-650-6). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA; 2007.
NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard –
Fifth Edition. NCCLS document H4-A5 [ISBN 1-56238-538-0]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA, 2004.
NCEP. 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), Final Report. NIH Publication No. 02–5215:
II-7, III-6. National Institutes of Health. Bethesda, Maryland: September 2002.
Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical
Microscopy. Northfield, IL: College of American Pathologists; 1992.
NCCLS. Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. NCCLS
document EP17-A [ISBN 1-56238-551-8]. NCCLS, 940 West Valley Road, Suite 1400 Wayne, Pennsylvania
19087-1898 USA, 2004.
Fossati P, Prencipe L. Serum Triglycerides Determined Colorimetrically with an Enzyme that Produces Hydrogen
Peroxide. Clin. Chem. 28:2077–2080; 1982.
CLSI. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline – Third
Edition. CLSI document C24-A3 (ISBN 1-56238-613-1). CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA; 2006.
CLSI. Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition. CLSI document EP7-A2 (ISBN
1-56238-584-4), CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA; 2005.
Stein EA, et al. National Cholesterol Education Program Recommendations for Triglyceride Measurement: Executive
Summary. Clin. Chem. 41:1421–1426; 1995.
Young DS. Effects of Drugs on Clinical Laboratory Tests. ed. 4. Washington D.C.: AACC Press; 1995.
Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990.
NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS Document
EP9. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA; 1995.
NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition
(Interim Revision). CLSI document EP9-A2-IR [ISBN 1-56238-731-6]. CLSI, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA; 2010.
NCCLS. User Evaluation of Precision Performance with Clinical Chemistry Devices. CLSI, 940 West Valley Road, Suite
1400, Wayne, PA 19087-1898 USA; 1992.
NCCLS. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second
Edition. NCCLS document EP5-A2 [ISBN 1-56238-542-9]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898 USA; 2004.
Pub. No. J40115_EN
Version 2.0
INSTRUCTIONS FOR USE
TRIG
Glossary of Symbols
Triglyceride For Coatings 3400 and Above
Glossary of Symbols
Revision History
Date of Revision
2015-10-12
Version
2.0
2014-01-15
1.0
Description of Technical Changes*
• Prescription Use statement added.
• Updated EC Representative address.
• Added USA to legal manufacture address
First release of document
* The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.
When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory
policies, as appropriate.
Signature
Version 2.0
Obsolete Date
Pub. No. J40115_EN
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INSTRUCTIONS FOR USE
TRIG
Triglyceride For Coatings 3400 and Above
Revision History
Ortho-Clinical Diagnostics
Felindre Meadows
Pencoed
Bridgend
CF35 5PZ
United Kingdom
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626
USA
VITROS is a registered trademark of
Ortho-Clinical Diagnostics, Inc.
© Ortho-Clinical Diagnostics, Inc., 2014–2015.
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Pub. No. J40115_EN
Version 2.0