Analytical performance evaluation of the Elecsys® Troponin T Gen 5 STAT assay

Robert L. Fitzgerald*, Judd E. Hollander, W. Frank Peacock, Alexander T. Limkakeng, Nancy Breitenbeck, Kareen Blechschmidt, Michael Laimighofer, Christopher deFilippi

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

24 Scopus citations

Abstract

Background: We report the analytical performance of the Elecsys® Troponin T Gen 5 STAT (TnT Gen 5 STAT; Roche Diagnostics) assay. Methods: Measuring limits/ranges were determined in lithium-heparin plasma samples per Clinical and Laboratory Standards Institute (CLSI) EP17-A2. Precision was evaluated per CLSI EP05-A2 using lithium-heparin plasma/quality control samples on cobas e 411/cobas e 601 analyzers; two duplicated runs per day for 21 days (n = 84). Cross-reactivity with other troponin forms and interference from endogenous substances/drugs was tested; recovery criterion for no cross-reactivity was within ±10%. Results: Coefficients of variation (CV) for repeatability/intermediate precision were 0.7–5.6%/1.4–10.3% (cobas e 411; mean cardiac troponin T [cTnT]: 7.3–9341 ng/L) and 0.7–3.0%/1.5–6.4% (cobas e 601; mean cTnT: 7.4–9455 ng/L). There was no cross-reactivity with skeletal muscle troponin T (≤ 10,000 ng/L), skeletal muscle troponin I (≤ 100,000 ng/L), cardiac troponin I (≤ 10,000 ng/L), or human troponin C (≤ 80,000 ng/L). No interference was observed with biotin (≤ 20 ng/mL) or 34 drugs. Conclusion: The TnT Gen 5 STAT assay demonstrated a CV of <10% at the 99th percentile upper reference limit, meeting precision requirements (Fourth Universal Definition of Myocardial Infarction) for high-sensitivity troponin assays.

Original languageEnglish
Pages (from-to)522-528
Number of pages7
JournalClinica Chimica Acta
Volume495
DOIs
StatePublished - Aug 2019
Externally publishedYes

Keywords

  • Cardiac troponin T, biotin
  • High-sensitivity
  • Myocardial infarction
  • Precision
  • Repeatability

Fingerprint

Dive into the research topics of 'Analytical performance evaluation of the Elecsys® Troponin T Gen 5 STAT assay'. Together they form a unique fingerprint.

Cite this