Catalog Number: 05944295160
This assay is used for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). The electrochemiluminescence binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.
Store at 2‑8 °C.
Traceability: This method has been standardized against the Elecsys Folate III assay ( 04476433160)/RBC application on the cobas e 411 analyzer.
120‑620 ng/mL or 272‑1407 nmol/L (defined by the Limit of Quantitation and the maximum of the master curve). Values below the Limit of Quantitation are reported as < 120 ng/mL (< 272 nmol/L). Values above the measuring range are reported as > 620 ng/mL (> 1407 nmol/L). Values are not corrected for the sample hematocrit.
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A requirements.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Precision was determined using Elecsys reagents and hemolysate samples 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). Results are given as whole blood folate (from hemolysate sample). The following results were obtained:
a) A comparison of the Elecsys Folate RBC assay (Elecsys 2010 analyzer; calibrated with Folate RBC CalSet; y) and the Elecsys Folate III/RBC application (cobas e 411 analyzer; calibrated with Elecsys Folate III CalSet; x) using hemolyzed clinical samples gave the following correlations (ng/mL). Results are given as whole blood folate (from hemolysate sample).