Tina-quant Apolipoprotein A-1 ver.2

Catalog Number: 03032566122

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

APOAT: ACN 168

For cobas c 502 analyzer:

APOAT: ACN 8168

INTENDED USE

In vitro test for the quantitative determination of Apolipoprotein A-1 in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

APOAT
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 12 weeks
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: 12 weeks

APPLICATION FOR SERUM AND PLASMA

cobas c 311 test definition
Assay type 2-Point End
Reaction time / Assay points 10 / 6-19
Wavelength (sub/main) 700/340 nm
Reaction direction Increase
Units g/L (µmol/L, mg/dL)
Reagent pipetting Diluent (H2O)
R1 100 µL
R2 25 µL 30 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 3 µL 9 µL 180 µL
Decreased 3 µL 9 µL 180 µL
Increased 6 µL 9 µL 180 µL

cobas c 501/502 test definition
Assay type 2-Point End
Reaction time / Assay points 10 / 10-28
Wavelength (sub/main) 700/340 nm
Reaction direction Increase
Units g/L (µmol/L, mg/dL)
Reagent pipetting Diluent (H2O)
R1 100 µL
R2 25 µL 30 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 3 µL 9 µL 180 µL
Decreased 3 µL 9 µL 180 µL
Increased 6 µL 9 µL 180 µL

CALIBRATION

Traceability: This method has been standardized against the IFCC SP1-01 reference standard (WHO-IRP October 1992).9,10,11,12

Calibrators S1: H2OS2-S6: C.f.a.s. Lipids
Multiply the lot-specific C.f.a.s. Lipids calibrator values by the factors below to determine the standard concentrations for the 6-point calibration curve:
S2: 0.208 S5: 1.313
S3: 0.412 S6: 2.006
S4: 1.000
Calibration mode RCM
Calibration frequency Full calibrationafter reagent lot change as required following quality control procedures

LIMITS AND RANGES

Measuring range

0.2-4.0 g/L (7.14-143 µmol/L, 20-400 mg/dL)

Determine samples having lower concentrations via the rerun function. For samples with lower concentrations, the rerun function increases the sample volume by a factor of 2. The results are automatically divided by this factor.

Lower limits of measurement

Lower detection limit of the test

0.03 g/L (1.07 µmol/L, 3 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).

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:

Repeatability Meang/L (µmol/L, mg/dL) SDg/L (µmol/L, mg/dL) CV%
Precinorm L 1.60 (57.1, 160) 0.02 (0.7, 2) 1.1
Precipath L 1.00 (35.7, 100) 0.01 (0.4, 1) 1.5
Human serum 1 0.99 (35.3, 99.0) 0.02 (0.7, 2) 1.5
Human serum 2 2.59 (92.5, 259) 0.02 (0.7, 2) 1.0

Intermediate precision Meang/L (µmol/L, mg/dL) SDg/L (µmol/L, mg/dL) CV%
Precinorm L 1.74 (62.1, 174) 0.08 (2.9, 8) 4.7
Precipath L 1.06 (37.8, 106) 0.04 (1.4, 4) 3.9
Human serum 3 1.17 (41.8, 117) 0.04 (1.4, 4) 3.6
Human serum 4 2.40 (85.7, 240) 0.03 (1.1, 3) 1.4

METHOD COMPARISON

Apolipoprotein A-1 values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the same reagent on a Roche/Hitachi 917 analyzer (x).

Sample size (n) = 126

Passing/Bablok19 Linear regression
y = 1.014x + 0.073 g/L y = 1.006x + 0.087 g/L
t = 0.949 r = 0.996
The sample concentrations were between 0.380 and 3.34 g/L (13.6 and 119 µmol/L, 38.0 and 334 mg/dL).