Catalog Number: 07398000160
For cobas e 411 analyzer: test number 1480For cobas e 601 and cobas e 602 analyzers: Application Code Number 188
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.
Store at 2‑8 °C.
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.
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).
Representative performance data on the analyzers are given below.Results obtained in individual laboratories may differ.
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:
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).