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

dc.contributor.author Fitzgerald, Robert L
dc.contributor.author Hollander, Judd E
dc.contributor.author Peacock, W Frank
dc.contributor.author Limkakeng, Alexander T
dc.contributor.author Breitenbeck, Nancy
dc.contributor.author Blechschmidt, Kareen
dc.contributor.author Laimighofer, Michael
dc.contributor.author deFilippi, Christopher
dc.date.accessioned 2020-10-22T00:50:35Z
dc.date.available 2020-10-22T00:50:35Z
dc.date.issued 2019-08
dc.identifier S0009-8981(19)31887-X
dc.identifier.issn 0009-8981
dc.identifier.issn 1873-3492
dc.identifier.uri https://hdl.handle.net/10161/21627
dc.description.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.
dc.language eng
dc.publisher Elsevier BV
dc.relation.ispartof Clinica chimica acta; international journal of clinical chemistry
dc.relation.isversionof 10.1016/j.cca.2019.05.026
dc.subject Humans
dc.subject Troponin T
dc.subject Blood Chemical Analysis
dc.subject Immunoassay
dc.subject Luminescent Measurements
dc.subject Reproducibility of Results
dc.subject Limit of Detection
dc.title Analytical performance evaluation of the Elecsys® Troponin T Gen 5 STAT assay.
dc.type Journal article
duke.contributor.id Limkakeng, Alexander T|0410606
dc.date.updated 2020-10-22T00:50:34Z
pubs.begin-page 522
pubs.end-page 528
pubs.organisational-group School of Medicine
pubs.organisational-group Surgery, Emergency Medicine
pubs.organisational-group Duke
pubs.organisational-group Surgery
pubs.organisational-group Clinical Science Departments
pubs.publication-status Published
pubs.volume 495
duke.contributor.orcid Limkakeng, Alexander T|0000-0002-9822-5595


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