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.date.updated | 2020-10-22T00:50:34Z | |
| 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.identifier | S0009-8981(19)31887-X | |
| dc.identifier.issn | 0009-8981 | |
| dc.identifier.issn | 1873-3492 | |
| dc.identifier.uri | ||
| 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.orcid | Limkakeng, Alexander T|0000-0002-9822-5595 | |
| 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 |
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