Unsaturated Iron-Binding Capacity

Catalog Number: 05975808190

SYSTEM INFORMATION

UIBCI: ACN 8779

INTENDED USE

In vitro test for the quantitative determination of the unsaturated iron-binding capacity in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

UIBC
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 3 weeks
On-board on the Reagent Manager: 24 hours

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

CALIBRATION

Enter the correction value for the calibration with Iron Standard as instrument factor y = ax + b, where a = -1.0 and b = 0.

Calibrators S1: H2OS2: Iron Standard
Calibration mode Linear
Calibration frequency 2-point calibration▪after reagent lot change▪as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

2-POINT CALIBRATION

ENTER THE CORRECTION VALUE FOR THE CALIBRATION WITH IRON STANDARD AS INSTRUMENT FACTOR Y = AX + B, WHERE A = -1.0 AND B = 0.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

3-125 µmol/L (16.8-700 µg/dL, 0.17-7 mg/L)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

NOTE: THE TECHNICAL LIMITS FOR THIS ASSAY ARE DEFINED AS -700 ΜG/DL FOR THE LOWER LIMIT AND -16.8 ΜG/DL FOR THE UPPER LIMIT DUE TO THE INSTRUMENT FACTOR FOR UIBC (A =  -1; SEE ABOVE CHAPTER "CALIBRATION"). RESULTS UNDER THE LOWER LIMIT OF THE MEASURING RANGE WILL BE FLAGGED WITH ">TEST". RESULTS ABOVE THE UPPER LIMIT OF THE MEASURING RANGE WILL BE FLAGGED WITH "<TEST".

NOTE: THE TECHNICAL LIMITS FOR THIS ASSAY ARE DEFINED AS -700 ΜG/DL FOR THE LOWER LIMIT AND -16.8 ΜG/DL FOR THE UPPER LIMIT DUE TO THE INSTRUMENT FACTOR FOR UIBC (A =  -1; SEE ABOVE CHAPTER "CALIBRATION"). RESULTS UNDER THE LOWER LIMIT OF THE MEASURING RANGE WILL BE FLAGGED WITH ">TEST". RESULTS ABOVE THE UPPER LIMIT OF THE MEASURING RANGE WILL BE FLAGGED WITH "<TEST".

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:

INTERMEDIATE PRECISION

METHOD COMPARISON

Serum