Jungbauer, Carsten and Hupf, Julian and Giannitsis, Evangelos and Frick, Johann and Slagman, Anna and Ehret, Christoph and Herbert, Nicolas and Jung, Christine and Zerback, Rainer and Bertsch, Thomas and Christ, Michael (2017) Analytical and Clinical Validation of a Point-of-Care Cardiac Troponin T Test with an Improved Detection Limit. CLINICAL LABORATORY, 63 (4). pp. 633-645. ISSN 1433-6510,
Full text not available from this repository. (Request a copy)Abstract
Background: The point-of-care test Roche CARDIAC POC Troponin T (PoC TnT) is an improved assay which has been developed for the Roche cobas h 232 system. Methods: We performed a multicentre evaluation (four sites) to assess the analytical performance of the PoC TnT assay and to compare it with the central laboratory Elecsys (R) troponin T high sensitive (lab cTnT-hs) assay. Results: The relative mean differences found in method comparisons of PoC TnT vs. lab cTnT-hs ranged from -4.1% to +6.8%. Additionally, there was good concordance between PoC TnT and lab cTnT-hs for the number of samples with troponin T values below the measuring range of 40 ng/L. Lot-to-lot differences of PoC TnT ranged from -8.6% to +4.6%. Within-series coefficients of variation (CV) resulting from 81 ten-fold measurements with patient samples were 9.3%, 11.8%, and 12.9% in the low (40 to < 200 ng/L), medium (200 to < 600 ng/L), and high (600 to 2000 ng/L) measuring range, respectively. Using the system quality control, the mean CV for between-day imprecision was 11.3%. No interference was observed by triglycerides (up to 11.4 mmol/L), bilirubin (up to 376 mu mol/L), hemoglobin (up to 0.12 mmol/L), biotin (up to 30 mu g/L), rheumatoid factor (up to 200 IU/mL), or with 52 standard or cardiovascular drugs at therapeutic concentrations. There was no influence on the results by varying hematocrit values in a range from 25% to 53%. However, interferences with human anti-mouse antibodies were found. No significant influence on the results was found with PoC TnT by using sample volumes between 135 to 165 mu L. High troponin T concentrations up to 500 mu g/L did not lead to false low results, indicating no high-concentration hook effect. No cross-reactivity was found between the PoC TnT assay and human skeletal troponin T up to 1000 mu g/L (< 0.05%). Diagnostic sensitivity and specificity data of a subpopulation (23 patients) of this study are in agreement with results of another large pre-hospital study. Conclusions: The PoC TnT assay showed good analytical performance with excellent concordance with the calibration and reference laboratory method. It should therefore be suitable for its intended use in point-of-care settings.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ACUTE MYOCARDIAL-INFARCTION; CHEST-PAIN; DEFINITION; DIAGNOSIS; COLLEGE; MARKERS; SYSTEM; STAY; TIME; UNIT; acute myocardial infarction; analytical performance; troponin T; multicentre evaluation; point-of-care testing |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 14 Dec 2018 12:57 |
| Last Modified: | 26 Feb 2019 10:52 |
| URI: | https://pred.uni-regensburg.de/id/eprint/47 |
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