Myoglobin

Catalog Number: 12178214160

INTENDED USE

Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. This assay is intended to aid in the rapid diagnosis of heart and renal disease.

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 Myoglobin STAT 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.

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:

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

21.0-3000 ng/mL (defined by the Limit of Detection and the maximum of the master curve). Values below the Limit of Detection are reported as < 21.0 ng/mL. Values above the measuring range are reported as > 3000 ng/mL (or up to 30000 ng/mL for 10-fold diluted samples).

21.0-3000 NG/ML (DEFINED BY THE LIMIT OF DETECTION AND THE MAXIMUM OF THE MASTER CURVE). VALUES BELOW THE LIMIT OF DETECTION ARE REPORTED AS < 21.0 NG/ML. VALUES ABOVE THE MEASURING RANGE ARE REPORTED AS > 3000 NG/ML (OR UP TO 30000 NG/ML FOR 10-FOLD DILUTED SAMPLES).

LOWER LIMITS OF MEASUREMENT

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

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 modified protocol (EP5-A2) of the CLSI (Clinical and Laboratory Standards Institute): 6 times daily for 10 days (n = 60). The following results were obtained:

PRECISION WAS DETERMINED USING ELECSYS REAGENTS, POOLED HUMAN SERA AND CONTROLS IN A MODIFIED PROTOCOL (EP5-A2) OF THE CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE): 6 TIMES DAILY FOR 10 DAYS (N = 60). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

A comparison of the Elecsys Myoglobin assay (y) with the Elecsys Myoglobin STAT assay (x) using clinical samples gave the following correlations:

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,