Catalog Number: 05944295160

SYSTEM INFORMATION

INTENDED USE

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.

RESULTS ARE DETERMINED VIA A CALIBRATION CURVE WHICH IS INSTRUMENT-SPECIFICALLY GENERATED BY 2‑POINT CALIBRATION AND A MASTER CURVE PROVIDED VIA THE REAGENT BARCODE OR E‑BARCODE.

STORAGE AND STABILITY

Store at 2‑8 °C.

CALIBRATION

Traceability: This method has been standardized against the Elecsys Folate III assay ( 04476433160)/RBC application on the cobas e 411 analyzer.

EVERY ELECSYS REAGENT SET HAS A BARCODED LABEL CONTAINING SPECIFIC INFORMATION FOR CALIBRATION OF THE PARTICULAR REAGENT LOT. THE PREDEFINED MASTER CURVE IS ADAPTED TO THE ANALYZER USING THE RELEVANT CALSET.

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

RENEWED CALIBRATION IS RECOMMENDED AS FOLLOWS:

CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER REAGENT KIT, AND FOLLOWING EACH CALIBRATION.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

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.

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.

LOWER LIMITS OF MEASUREMENT

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.

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

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:

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:

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

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).