Folate III

Catalog Number: 07559992160

SYSTEM INFORMATION

For cobas e 411 analyzer: test number 1520For MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Application Code Number 721

INTENDED USE

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.

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 WHO International Standard NIBSC code: 03/178.

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

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).

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).

LOWER LIMITS OF MEASUREMENT

Limit of Blank, Limit of Detection and Limit of Quantitation

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, 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:

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:

METHOD COMPARISON

A comparison of the Elecsys Folate III assay (y) and a commercially available method (x) using clinical samples gave the following correlations (ng/mL):