Tina-quant Albumin Gen.2 - Urine Application

Catalog Number: 04469658190

SYSTEM INFORMATION

Test ALBU2, test ID 0-171 on COBAS INTEGRA 400 plus systems; test ID 0-343 on COBAS INTEGRA 800 systems

INTENDED USE

In vitro test for the quantitative immunological determination of albumin in human urine, serum and plasma on COBAS INTEGRA systems.

STORAGE AND STABILITY

Shelf life at 2-8 °C See expiration date on cobas c pack label
COBAS INTEGRA 400 plus system
On-board in use at 10-15 °C 12 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 12 weeks

Specimen collection and preparation

COBAS INTEGRA 400 PLUS TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-S-R2-SR
Reaction direction Increase
Reaction start with R2
Wavelength A/B 340/659 nm
Calc. first/last 33/49
Typical prozone effect > 600 mg/L (> 60 mg/dL or > 9.12 µmol/L)
Antigen excess check Yes (with SR)
Predilution factor No
Postconcentration factor No
Unit mg/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 100 µL -
Sample 6 µL 15 µL
R2 20 µL -
SR 6 µL 10 µL
Total volume 157 µL

Diluent (H2O)
R1 100 µL 80 µL
R2 20 µL -
Sample 6 µL 10 µL
SR 6 µL 10 µL
Total volume 232 µL

COBAS INTEGRA 800 test definition

Calibration

COBAS INTEGRA 800 TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-R2-S-SR
Reaction direction Increase
Reaction start with Sample
Wavelength A/B 340/659 nm
Calc. first/last T0 /44
Typical prozone effect > 1500 mg/L (> 150 mg/dL or > 22.8 µmol/L)
Antigen excess check Yes (with SR)
Predilution factor No
Postconcentration factor No
Unit mg/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 100 µL 80 µL
R2 20 µL -
Sample 6 µL 10 µL
SR 6 µL 10 µL
Total volume 232 µL

Calibration

CALIBRATION

Enter the assigned lot-specific albumin value of the undiluted calibrator (mg/L), indicated in the package insert of C.f.a.s. PUC.

Calibrator C.f.a.s. PUC
Calibration dilution ratio 1:2, 1:4, 1:8, 1:16, 1:32, 1:64 performed automatically by the instrument
Calibration mode Logit/log 4
Calibration replicate Duplicate recommended
Calibration interval Each lot and as required following quality control procedures

CALIBRATION DILUTION RATIO

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

12-200 mg/L (0.182-3.10 µmol/L or 1.2-20.0 mg/dL)

LOWER LIMITS OF MEASUREMENT

Limit of Blank, Limit of Detection and Limit of Quantitation:

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 (1 aliquot per run, 1 run per day, 21 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 21) AND INTERMEDIATE PRECISION (1 ALIQUOT PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

Albumin values for human urine samples obtained on a COBAS INTEGRA 800 analyzer using the COBAS INTEGRA Tina-quant  Albumin Gen.2 reagent (y) were compared with those determined using the same reagent on a cobas c 501 analyzer (x).