Long-time quality assessment of the Elecsys Troponin T hs assay
Ola Hammarsten1, Carl-Eric Jacobsson1, Monica Widegren1
1Department of Clinical Chemistry and Transfusion Medicine, Sahlgrenska University Hospital at Sahlgrenska Academy, University of Gothenburg, S-413 45 Gothenburg, Sweden.
Insights
Roche
Area of Science:
- Clinical Chemistry
- Cardiovascular Diagnostics
- Laboratory Medicine
Background:
- A calibrator issue affected Roche's high-sensitive cardiac troponin T (hscTnT) assay.
- This assay is crucial for diagnosing myocardial infarction.
- Laboratories need to understand the impact of such issues on patient results.
Purpose of the Study:
- To quantify the effect of the Roche hscTnT assay calibrator problem on measured troponin T concentrations.
- To assess the impact on results around the 99th percentile cut-off value.
- To provide a methodology for other laboratories to evaluate similar assay performance issues.
Main Methods:
- Longitudinal monitoring of hscTnT assay performance data from December 2009.
- Analysis of measured cardiac troponin T (cTnT) concentrations before and after assay recalibration in May 2012.
- Calculation of the change in cTnT levels around the 99th percentile.
Main Results:
- A significant drop of 5.8 ng/L in measured cTnT concentration was observed around the 99th percentile.
- This underestimation of cTnT levels occurred from assay introduction until recalibration.
- The findings highlight a systematic bias introduced by the calibrator problem.
Conclusions:
- The Roche hscTnT assay calibrator issue led to underestimation of cardiac troponin T levels near the critical 99th percentile cut-off.
- This underestimation has been present since the assay's clinical introduction.
- Laboratories should consider similar monitoring approaches to ensure assay accuracy and reliability.
Abstract:
Recently, Roche announced a problem with the calibrators for their high sensitive cardiac troponin T (hscTnT) assay. We have monitored the performance of the assay since its introduction into clinical use in December 2009 and we're in a unique position to provide quantitative information concerning the effects of this problem. Our data document that the measured cTnT concentration in the hscTnT assay dropped by 5.8 ng/L around the 99th percentile before its recalibration in May 2012. Thus, the hscTnT levels in our hospital have been underestimated around this cut-off value since its introduction. The approach we used may be one that other laboratories should consider.
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