Troponin I

Catalog Number: 05094810160

INTENDED USE

Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. This assay is intended to aid in the diagnosis of myocardial infarction.

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 a commercially available troponin I 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

0.300-25.0 µg/L or ng/mL (defined by the Limit of Quantitation and the maximum of the master curve). Values above the measuring range are reported as > 25.0 µg/L or ng/mL (or up to 250 µg/L or ng/mL for 10-fold diluted samples). Due to an imprecision of greater than 10 % below the cutoff of 0.300 ng/mL, it is not recommended to use this assay in the assessment of patients at the 99th percentile.

0.300-25.0 ΜG/L OR NG/ML (DEFINED BY THE LIMIT OF QUANTITATION AND THE MAXIMUM OF THE MASTER CURVE). VALUES ABOVE THE MEASURING RANGE ARE REPORTED AS > 25.0 ΜG/L OR NG/ML (OR UP TO 250 ΜG/L OR NG/ML FOR 10-FOLD DILUTED SAMPLES). DUE TO AN IMPRECISION OF GREATER THAN 10 % BELOW THE CUTOFF OF 0.300 NG/ML, IT IS NOT RECOMMENDED TO USE THIS ASSAY IN THE ASSESSMENT OF PATIENTS AT THE 99PERCENTILE.

0.300-25.0 ΜG/L OR NG/ML (DEFINED BY THE LIMIT OF QUANTITATION AND THE MAXIMUM OF THE MASTER CURVE). VALUES ABOVE THE MEASURING RANGE ARE REPORTED AS > 25.0 ΜG/L OR NG/ML (OR UP TO 250 ΜG/L OR NG/ML FOR 10-FOLD DILUTED SAMPLES). DUE TO AN IMPRECISION OF GREATER THAN 10 % BELOW THE CUTOFF OF 0.300 NG/ML, IT IS NOT RECOMMENDED TO USE THIS ASSAY IN THE ASSESSMENT OF PATIENTS AT THE 99PERCENTILE.

Precision was determined using Elecsys reagents, pooled human sera and controls in a protocol

LOWER LIMITS OF MEASUREMENT

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

THE LIMIT OF QUANTITATION (FUNCTIONAL SENSITIVITY) IS THE LOWEST ANALYTE CONCENTRATION THAT CAN BE REPRODUCIBLY MEASURED WITH AN INTERMEDIATE PRECISION CV OF ≤ 10 %.

Precision was determined using Elecsys reagents, pooled human sera and controls in a protocol

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

INTERMEDIATE PRECISION

METHOD COMPARISON

A comparison of the Elecsys Troponin I assay (MODULAR ANALYTICS E170 analyzer; y) and the Elecsys Troponin I STAT assay (Elecsys 2010 analyzer; x) using clinical samples gave the following correlations (µg/L or ng/mL):

ANALYTICAL SPECIFICITY

The Elecsys Troponin I assay does not show any significant cross-reaction with the following substances (tested with troponin I concentrations of approximately 0.400 ng/mL and 3.00 ng/mL):

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,