Elecsys Vitamin B12 II

Catalog Number: 07212771160

SYSTEM INFORMATION

For cobas e 411 analyzer: test number 1410For MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Application Code Number 224

INTENDED USE

Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

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 Vitamin B12 assay ( 04745736). Accuracy to WHO Standard 03/178:A study was performed to evaluate the accuracy of the Elecsys Vitamin B12 II assay using the Vitamin B12 World Health Organization International Standard 03/178.10 Two reagent lots were used on 16 instruments. The mean recovery of the target value of WHO IS 03/178 (480 pg/mL) was 102 %.

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.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

150‑2000 pg/mL or 111‑1476 pmol/L (defined by the Limit of Quantitation and the maximum of the master curve). Values below the Limit of Quantitation are reported as < 150 pg/mL or < 111 pmol/L. Values above the measuring range are reported as > 2000 pg/mL or > 1476 pmol/L.

150‑2000 PG/ML OR 111‑1476 PMOL/L (DEFINED BY THE LIMIT OF QUANTITATION AND THE MAXIMUM OF THE MASTER CURVE). VALUES BELOW THE LIMIT OF QUANTITATION ARE REPORTED AS < 150 PG/ML OR < 111 PMOL/L. VALUES ABOVE THE MEASURING RANGE ARE REPORTED AS > 2000 PG/ML OR > 1476 PMOL/L.

LOWER LIMITS OF MEASUREMENT

Limit of Blank, Limit of Detection and Limit of Quantitation

SAMPLE-DEPENDENT NON‑LINEARITY UPON DILUTION IS SEEN WITH SAMPLES HAVING ANALYTE LEVELS BEYOND THE MEASURING RANGE. AS DILUENT UNIVERSAL MAY CONTAIN LOW LEVELS OF ENDOGENOUS VITAMIN B, IT IS RECOMMENDED THAT LINEARITY STUDIES BE PERFORMED USING A KNOWN LOW ANALYTE-CONTAINING SERUM POOL. SAMPLES OUTSIDE THE MEASURING RANGE CAN BE DILUTED 1:2 WITH DILUENT UNIVERSAL; THE EFFECT OF ENDOGENOUS VITAMIN BCONCENTRATION IS INSIGNIFICANT AT THESE LEVELS.

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:

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

A comparison of the Elecsys Vitamin B12 assay (calibrated with Vitamin B12 CalSet II; x) and the Elecsys Vitamin B12 II assay (calibrated with Vitamin B12 II CalSet; y) using clinical samples gave the following correlations (pg/mL):

ANALYTICAL SPECIFICITY

The following cross-reactivities were found, tested with vitamin B12 concentrations of 129 pg/mL and 550 pg/mL.