Catalog Number: 05944295160

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.

STORAGE AND STABILITY

Store at 2-8 °C.

CALIBRATION

Traceability: This method has been standardized against the Elecsys Folate III assay

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.

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

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 duplication 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 DUPLICATION 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 Elecsys 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).

BABLOK W, PASSING H, BENDER R, ET AL. A GENERAL REGRESSION PROCEDURE FOR METHOD TRANSFORMATION. APPLICATION OF LINEAR REGRESSION PROCEDURES FOR METHOD COMPARISON STUDIES IN CLINICAL CHEMISTRY, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.