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

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Fitzgerald, RL; Hollander, JE; Peacock, WF; Limkakeng, AT; Breitenbeck, N; Blechschmidt, K; Laimighofer, M; deFilippi, C

Published Date

  • August 2019

Published In

Volume / Issue

  • 495 /

Start / End Page

  • 522 - 528

PubMed ID

  • 31152695

Pubmed Central ID

  • 31152695

Electronic International Standard Serial Number (EISSN)

  • 1873-3492

Digital Object Identifier (DOI)

  • 10.1016/j.cca.2019.05.026

Language

  • eng

Conference Location

  • Netherlands