Elecsys Troponin T Gen 5 STAT

Catalog Number: 07398000160

SYSTEM INFORMATION

For cobas e 411 analyzer: test number 1480For cobas e 601 and cobas e 602 analyzers: Application Code Number 188

INTENDED USE

Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay 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 OR E‑BARCODE.

STORAGE AND STABILITY

Store at 2‑8 °C.

CALIBRATION

Traceability: This method has been standardized against the Elecsys Troponin T STAT assay ( 04660307, 4th generation). This in turn was originally standardized against the Enzymun‑Test Troponin T (CARDIAC T) method.

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).

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

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

6-10000 ng/L (defined by the Limit of Quantitation and the maximum of the master curve). Values below 6 ng/L are reported as < 6 ng/L. Values above the measuring range are reported as > 10000 ng/L (or up to 100000 ng/L for 10‑fold diluted samples).

6-10000 NG/L (DEFINED BY THE LIMIT OF QUANTITATION AND THE MAXIMUM OF THE MASTER CURVE). VALUES BELOW 6 NG/L ARE REPORTED AS < 6 NG/L. VALUES ABOVE THE MEASURING RANGE ARE REPORTED AS > 10000 NG/L (OR UP TO 100000 NG/L FOR 10‑FOLD DILUTED SAMPLES).

LOWER LIMITS OF MEASUREMENT

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 (Li‑heparin plasma) 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). Human plasma samples and PreciControl Troponin were run on both the cobas e 411 analyzer and the cobas e 601 analyzer using three lots of reagents. The following representative results were obtained:

ANALYTICAL SPECIFICITY

The Elecsys Troponin T Gen 5 STAT assay does not show any significant cross‑reaction with the following substances (tested with cTnT concentrations of approximately 14 ng/L, 4000 ng/L and 7000 ng/L).