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Performance evaluation of a new high-sensitivity cardiac troponin T assay: hs-cTnT (CLIA) assay

Xin Shu1, Chenbin Zhang1, Ting Deng1

  • 1Clinical Laboratory, Wuhan Asia General Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, China.

Clinical Chemistry and Laboratory Medicine
|November 25, 2025
PubMed

Insights

The novel Mindray high-sensitivity cardiac troponin T (hs-cTnT) assay demonstrates excellent analytical and clinical performance for diagnosing myocardial infarction. This chemiluminescence immunoassay (CLIA) offers a reliable alternative for evaluating myocardial injury.

Area of Science:

  • Clinical Chemistry
  • Cardiovascular Diagnostics
  • Biomarker Assay Development

Background:

  • The Fourth Universal Definition of Myocardial Infarction emphasizes high-sensitivity cardiac troponin (hs-cTn) for diagnosing myocardial infarction.
  • Accurate and reliable hs-cTn assays are crucial for timely and effective patient management.

Purpose of the Study:

  • To evaluate the analytical and clinical performance of a new hs-cTnT chemiluminescence immunoassay (CLIA) developed by Mindray.
  • To compare the Mindray hs-cTnT assay with an established assay (Roche hs-cTnT Gen 5).

Main Methods:

  • Analytical performance was assessed for precision, sensitivity (LoD, LoQ), linearity, and interferences.
  • Sex-specific 99th percentile upper reference limits (URLs) were determined in healthy individuals.
  • Clinical diagnostic performance was evaluated in patients with suspected acute myocardial infarction.

Main Results:

  • The Mindray assay exhibited excellent precision (CV≤6.11%), superior sensitivity (LoD: 1.4 ng/L), and strong linearity (r=0.9978).
  • Measurable values were detected in over 91% of individuals, meeting high-sensitivity criteria.
  • Clinical evaluation showed 100% sensitivity, 83.3% specificity, and an AUC of 0.988, comparable to the Roche assay.

Conclusions:

  • The Mindray hs-cTnT (CLIA) assay meets high-sensitivity assay requirements.
  • The assay demonstrates robust analytical and diagnostic performance, serving as a dependable option for myocardial injury assessment.
Abstract

Keywords:
acute myocardial infarctionanalytical performancechemiluminescence immunoassaydiagnostic performancehigh-sensitivity cardiac troponin T

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