Triglycerides/Glycerol Blanked

Catalog Number: 05976006190

SYSTEM INFORMATION

TRIGB: ACN 8783

INTENDED USE

In vitro test for the quantitative determination of triglycerides with glycerol blanking in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

TRIGB
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 2 weeks
On-board on the Reagent Manager: 0 hours
Diluent NaCl 9 %
Shelf life at 2-8 °C: See expiration date on cobas c pack label
On-board in use and refrigerated on the analyzer: 4 weeks
On-board on the Reagent Manager: 24 hours

APPLICATION FOR SERUM AND PLASMA

cobas c 701/702 test definition
Assay type 1-Point
Reaction time / Assay points 10 / 38
Wavelength (sub/main) 700 / 505 nm
Reaction direction Increase
Units mmol/L (mg/dL, g/L)
Reagent pipetting Diluent (H2O)
R1 100 µL
R3 100 µL

Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL
Decreased 4 µL 15 µL 150 µL
Increased 4 µL

 

CALIBRATION

Traceability: This method has been standardized against SRM 909b and triolein standards.

Calibrators S1: Precimat GlycerolS2: C.f.a.s.
Calibration mode Linear
Calibration frequency 2-point calibration- after 24 hours on board- after cobas c pack change- as required following quality control procedures

LIMITS AND RANGES

Measuring range

0.1-10.0 mmol/L (8.85-885 mg/dL)

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:5.5 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 5.5.

Low recovery of triglycerides values may be due to low free glycerol values (< 0.0113 mmol/L or

< 1 mg/dL). Samples with a value of < 1.13 mmol/L (or < 100 mg/dL) triglycerides must be diluted with Precimat Glycerol as follows: 20 parts sample plus 1 part Precimat Glycerol. Rerun the diluted sample. Multiply the rerun result by the dilution factor of 1.05.

Lower limits of measurement

Lower detection limit of the test

0.1 mmol/L (8.85 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard

1 + 3 SD, repeatability, n = 21).

Values below the lower detection limit (< 0.1 mmol/L) will not be flagged by the instrument.

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Results for intermediate precision were obtained on the master system cobas c 501 analyzer.

Repeatability
Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Precinorm L 1.41 (125) 0.01 (1) 0.9
Precipath U 0.661 (58.5) 0.007 (0.6) 1.1
Human serum A 2.69 (238) 0.02 (2) 0.6
Human serum B 4.14 (366) 0.03 (3) 0.6
Human serum C 5.66 (501) 0.03 (3) 0.5
Human serum D 8.30 (735) 0.04 (4) 0.5

Intermediate precision
Meanmmol/L (mg/dL) SDmmol/L (mg/dL) CV%
Precinorm U 0.53 (46.9) 0.01 (0.9) 2.7
Precipath U 0.62 (54.9) 0.02 (1.8) 2.8
Human serum 3 0.64 (56.6) 0.02 (1.8) 2.7
Human serum 4 5.82 (515) 0.07 (6) 1.1

METHOD COMPARISON

Triglycerides values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 80

Passing/Bablok15 Linear regression
y = 0.992x - 0.022 mmol/L y = 0.991x - 0.023 mmol/L
τ = 0.990 r = 1.000
The sample concentrations were between 0.220 and 8.95 mmol/L (19.5 and 792 mg/dL)