CK-MB - the MB isoenzyme of creatine kinase (STAT "Short Turn Around Time")

Catalog Number: 05957648160

INTENDED USE

Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma.

STORAGE AND STABILITY

Store at 2-8 °C.

CALIBRATION

Traceability: The Elecsys CK-MB STAT assay is traceable to the Abbott IMx CK-MB assay and linearized using human recombinant CK-MB​4 from Seradyn.

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 MUST BE PERFORMED ONCE PER REAGENT LOT USING FRESH REAGENT (I.E. NOT MORE THAN 24 HOURS SINCE THE REAGENT KIT WAS REGISTERED ON THE ANALYZER). RENEWED CALIBRATION IS RECOMMENDED AS FOLLOWS:

LIMITS AND RANGES

Measuring range

MEASURING RANGE

1-300 ng/mL (defined by the Limit of Quantitation and the maximum of the master curve). Values below the Limit of Quantitation are reported as < 1 ng/mL. Values above the measuring range are reported as > 300 ng/mL (or up to 600 ng/mL for 2-fold diluted samples).

1-300 NG/ML (DEFINED BY THE LIMIT OF QUANTITATION AND THE MAXIMUM OF THE MASTER CURVE). VALUES BELOW THE LIMIT OF QUANTITATION ARE REPORTED AS < 1 NG/ML. VALUES ABOVE THE MEASURING RANGE ARE REPORTED AS > 300 NG/ML (OR UP TO 600 NG/ML FOR 2-FOLD DILUTED SAMPLES).

LOWER LIMITS OF MEASUREMENT

Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ)

LIMIT OF QUANTITATION = 1 NG/ML WITH AN INTERMEDIATE PRECISION COEFFICIENT OF VARIATION OF ≤ 20 %.

Precision was determined using Elecsys reagents, samples and controls 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). The following results were obtained:

THE LIMIT OF QUANTITATION IS DEFINED AS THE LOWEST AMOUNT OF ANALYTE THAT CAN BE REPRODUCIBLY MEASURED WITH AN INTERMEDIATE PRECISION COEFFICIENT OF VARIATION OF ≤ 20 %.

Precision was determined using Elecsys reagents, samples and controls 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). The following results were obtained:

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, samples and controls 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). The following results were obtained:

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

A comparison of the Elecsys CK-MB STAT assay (y) with the Elecsys CK-MB STAT assay - previous version (x) using clinical samples gave the following correlations:

ANALYTICAL SPECIFICITY

For the monoclonal antibodies used, the following cross-reactivities were found:

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.