Tina-quant Ferritin Gen.4

Catalog Number: 04885317190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

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

STORAGE AND STABILITY

FERR4
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

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

cobas c 311 test definition
Assay type 2-Point End
Reaction time / Assay points 10 / 24-57
Wavelength (sub/main) 800/570 nm
Reaction direction Increase
Units µg/L (pmol/L, ng/mL)
Reagent pipetting Diluent (H2O)
R1 80 µL
R3 80 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 10 µL
Decreased 10 µL 20 µL 140 µL
Increased 10 µL

 

CALIBRATION

Traceability: This method has been standardized against the Elecsys Ferritin assay (immunological method) which is traceable to NIBSC (WHO).

Calibrators S1: H2OS2-6: C.f.a.s. Proteins
Multiply the lot-specific C.f.a.s. Proteins calibrator value by the factors below to determine the standard concentrations for the 6-point calibration curve:
S2: 0.0270 S5: 0.5000
S3: 0.1120 S6: 1.3000
S4: 0.2300
Calibration mode Spline
Calibration frequency Full calibration▪after reagent lot change▪as required following quality control procedures

MULTIPLY THE LOT-SPECIFIC C.F.A.S. PROTEINS 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

5-1000 µg/L (11.2-2247 pmol/L, 5-1000 ng/mL)

LOWER LIMITS OF MEASUREMENT

Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ)

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 accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5 requirements with repeatability (n = 84) and intermediate precision (4 aliquots per run, 1 run per day, one lot of reagent, 21 days) on a Roche/Hitachi cobas c 501 analyzer. The following results were obtained:

INTERMEDIATE PRECISION

METHOD COMPARISON

Ferritin values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer using the Tina-quant Ferritin Gen.4 assay (y) were compared with those determined using the Tina-quant Ferritin assay on a Roche/Hitachi 917 analyzer (x).