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.

Clinical Biochemistry
|April 13, 2013
PubMed

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.

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