Catalog Number: 07212771160
For cobas e 411 analyzer: test number 1410For MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Application Code Number 224
Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Store at 2‑8 °C.
Traceability: This method has been standardized against the Elecsys Vitamin B12 assay ( 04745736). Accuracy to WHO Standard 03/178:A study was performed to evaluate the accuracy of the Elecsys Vitamin B12 II assay using the Vitamin B12 World Health Organization International Standard 03/178.10 Two reagent lots were used on 16 instruments. The mean recovery of the target value of WHO IS 03/178 (480 pg/mL) was 102 %.
150‑2000 pg/mL or 111‑1476 pmol/L (defined by the Limit of Quantitation and the maximum of the master curve). Values below the Limit of Quantitation are reported as < 150 pg/mL or < 111 pmol/L. Values above the measuring range are reported as > 2000 pg/mL or > 1476 pmol/L.
Limit of Blank, Limit of Detection and Limit of Quantitation
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Precision was determined using Elecsys reagents, pooled human sera and controls in a protocol (EP5‑A2) of the CLSI (Clinical and Laboratory Standards Institute): 2 runs per day in duplicate each for 21 days (n = 84). The following results were obtained:
A comparison of the Elecsys Vitamin B12 assay (calibrated with Vitamin B12 CalSet II; x) and the Elecsys Vitamin B12 II assay (calibrated with Vitamin B12 II CalSet; y) using clinical samples gave the following correlations (pg/mL):
The following cross-reactivities were found, tested with vitamin B12 concentrations of 129 pg/mL and 550 pg/mL.