Tina-quant Soluble Transferrin Receptor

Catalog Number: 20763454122

SYSTEM INFORMATION

Test STFR, test ID 0-145

INTENDED USE

In vitro test for the quantitative immunological determination of soluble transferrin receptor in human 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

APPLICATION FOR SERUM AND PLASMA

COBAS INTEGRA 400 PLUS TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-R2-S
Reaction direction Increase
Wavelength A/B 583 nm
Calc. first/last T0/61
Typical prozone effect > 80.0 mg/L
Antigen excess check No
Unit mg/L

PIPETTING PARAMETERS

Diluent (H2O)
R1 110 µL
R2 110 µL
Sample 2.25 µL 20 µL
Total volume 242.25 µL

Diluent (H2O)
R1 110 µL
R2 110 µL
Sample 2.25 µL 20 µL
Total volume 242.25 µL

COBAS INTEGRA 800 TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-R2-S
Reaction direction Increase
Wavelength A/B 583 nm
Calc. first/last T0/65
Typical prozone effect > 80.0 mg/L
Antigen excess check No
Unit mg/L

PIPETTING PARAMETERS

Diluent (H2O)
R1 110 µL
R2 110 µL
Sample 2.25 µL 20 µL
Total volume 242.25 µL

CALIBRATION

Calibrators must be placed from the highest concentration first, to the lowest last, on the CAL/QC rack. Zero calibrator is not provided with Preciset sTfR. Please use 0.9 % NaCl.

Traceability: This method has been standardized against an in-house reference preparation.10

Calibrator Preciset sTfR, ready to use
Calibration mode Logit/log 5
Calibration replicate Duplicate recommended
Calibration interval Each lot and every 6 days and as required following quality control procedures

LIMITS AND RANGES

Measuring range

0.5-20.0 mg/L

Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Lower detection limit of the test:

0.5 mg/L

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 a zero sample (zero sample + 3 SD, repeatability, n = 21).

SPECIFIC PERFORMANCE DATA

Representative performance data on the COBAS INTEGRA 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:

Repeatability Meanmg/L CV%
Level 1 3.17 0.76
Level 2 18.9 1.1
Intermediate precision Meanmg/L CV%
Level 1 2.52 2.0
Level 2 11.4 2.2

METHOD COMPARISON

STfR values for human serum samples obtained on a COBAS INTEGRA 700 analyzer with the COBAS INTEGRA Tina-quant Soluble Transferrin Receptor reagent (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

Roche/Hitachi 917 analyzer
Sample size (n) 69
Corr. coefficient (r) 0.999
Lin. regression y = 0.93x + 0.20 mg/L
Passing/Bablok17 y = 0.94x + 0.21 mg/L
The sample concentrations were between 0.31 and 19.86 mg/L.

ANALYTICAL SPECIFICITY/CROSS-REACTIVITY