Catalog Number: 07559992160
For cobas e 411 analyzer: test number 1520For MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Application Code Number 721
Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Folic acid measurements are used in the diagnosis and treatment of anemias.
Store at 2‑8 °C.
Traceability: This method has been standardized against the WHO International Standard NIBSC code: 03/178.
2.0 ‑ 20.0 ng/mL or 4.54 ‑ 45.4 nmol/L (defined by the Limit of Quantitation and the maximum of the master curve). Values below the Limit of Quantitation are reported as < 2.0 ng/mL (< 4.54 nmol/L). Values above the measuring range are reported as > 20.0 ng/mL (> 45.4 nmol/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 Folate III assay (y) and a commercially available method (x) using clinical samples gave the following correlations (ng/mL):