Tina-quant Albumin Gen.2

Catalog Number: 05167043190

SYSTEM INFORMATION

ALBU2: ACN 8253 (Albumin in urine)

INTENDED USE

In vitro test for the quantitative determination of albumin in human serum, plasma, urine and CSF on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

ALBT2
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
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 2-Point End
Reaction time / Assay points 10 / 18-26
Wavelength (sub/main) 700/340 nm
Reaction direction Increase
Units g/L (µmol/L, mg/dL)
Reagent pipetting Diluent (H2O)
R1 100 µL
R3 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2.0 µL 2.1 µL 175 µL
Decreased 2.0 µL 1.7 µL 180 µL
Increased 4.0 µL 2.1 µL 175 µL

CALIBRATION

Traceability: This method has been standardized against the certified reference material in human serum of the IRMM (Institute for Reference Material and Measurements) ERM-DA470k/IFCC.

Calibrators S1: H2O
S2-6: C.f.a.s. PUC
Multiply the lot-specific C.f.a.s. PUC calibrator value by the factors below to determine the standard concentrations for the 6-point calibration curve:
S2: 0.0138 S5: 0.467
S3: 0.0228 S6: 1.00
S4: 0.0455
Calibration mode RCM
Calibration frequency Full calibration▪after reagent lot change▪as required following quality control procedures

MULTIPLY THE LOT-SPECIFIC C.F.A.S. PUC CALIBRATOR VALUE BY THE FACTORS BELOW TO DETERMINE THE STANDARD CONCENTRATIONS FOR THE 6-POINT CALIBRATION CURVE:

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

Urine

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 (3 aliquots 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 (3 ALIQUOTS PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

Albumin values for human serum, plasma, urine and CSF samples obtained on a Roche/Hitachi