Troponin I STAT (Short Turn Around Time)

Catalog Number: 05094798160

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.

GIVEN THAT CTNI AS WELL AS CARDIAC TROPONIN T ARE INDEPENDENT MARKERS WHICH BEST PREDICT THE OUTCOME OF PATIENTS WITH ACS, THE JOINT COMMITTEE OF THE EUROPEAN SOCIETY OF CARDIOLOGY (ESC) AND AMERICAN COLLEGE OF CARDIOLOGY (ACC) REDEFINED MYOCARDIAL INFARCTION (MI). ACCORDING TO THIS REDEFINITION, MI IS DIAGNOSED WHEN BLOOD LEVELS OF CARDIAC TROPONIN ARE ABOVE THE 99 PERCENTILE OF THE REFERENCE LIMIT (OF A HEALTHY POPULATION) IN THE CLINICAL SETTING OF ACUTE ISCHEMIA. THE IMPRECISION (COEFFICIENT OF VARIATION) AT THE 99 PERCENTILE FOR TROPONIN ASSAYS IS REQUIRED TO BE LESS THAN OR EQUAL TO 10 %.

Precision was determined using Elecsys reagents, pooled human sera and controls in a protocol (EP5-A2) of the CLSI (Clinical and Laboratory Standards Institute): each sample was measured in 21 runs with 3 consecutive measurements on different days (n = 63). The following results were obtained:

STORAGE AND STABILITY

CALIBRATION

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

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 99 PERCENTILE.

Precision was determined using Elecsys reagents, pooled human sera and controls in a protocol (EP5-A2) of the CLSI (Clinical and Laboratory Standards Institute): each sample was measured in 21 runs with 3 consecutive measurements on different days (n = 63). The following results were obtained:

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 (EP5-A2) of the CLSI (Clinical and Laboratory Standards Institute): each sample was measured in 21 runs with 3 consecutive measurements on different days (n = 63). The following results were obtained:

SAMPLES WITH TROPONIN I CONCENTRATIONS ABOVE THE MEASURING RANGE CAN BE DILUTED WITHDILUENT MULTIASSAY. THE RECOMMENDED DILUTION IS 1:10 (EITHER AUTOMATICALLY BY THE ELECSYS 2010 ANDANALYZERS OR MANUALLY). THE CONCENTRATION OF THE DILUTED SAMPLE MUST BE > 3.00 ΜG/L (NG/ML).

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): each sample was measured in 21 runs with 3 consecutive measurements on different days (n = 63). 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): EACH SAMPLE WAS MEASURED IN 21 RUNS WITH 3 CONSECUTIVE MEASUREMENTS ON DIFFERENT DAYS (N = 63). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

PRECISION WAS DETERMINED USING ELECSYS REAGENTS, POOLED HUMAN SERA AND CONTROLS IN A SEPARATE STUDY ACCORDING TO 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

METHOD COMPARISON

A comparison of the Elecsys Troponin I STAT assay (y) with a commercially available troponin I assay (x) using clinical samples gave the following correlations (µg/L or ng/mL):

ANALYTICAL SPECIFICITY

THE STUDY SUBJECTS USED TO DETERMINE THE CUTOFF VALUE FOR TROPONIN I WERE RECRUITED IN ONE EUROPEAN SITE AND ONE US SITE (N = 358). WHEN USING THE ACC/ESC/AHA DIAGNOSTIC CRITERIA THERE WERE A TOTAL OF 69 AMIS (19 %) IN THIS POPULATION. SENSITIVITY (84 %) AND SPECIFICITY (94 %) WERE OPTIMAL AT 0.300 NG/ML. BECAUSE OF THE INCREASE IN IMPRECISION BELOW 0.300 NG/ML, IT IS NOT RECOMMENDED TO USE THIS ASSAY IN THE ASSESSMENT OF PATIENTS AT THE 99 PERCENTILE.

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.