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Clinical performance validation and four diagnostic strategy assessments of high-sensitivity troponin I assays

Junyi Wu1, Yaotong Hua1,2, Yilin Ge1

  • 1Department of Laboratory Medicine, Beijing Anzhen Hospital, Capital Medical University, Chaoyang District, Beijing, 100020, China.

Scientific Reports
|April 25, 2025
PubMed

Insights

The hs-cTnI 0/2 h Algorithm provides the most reliable early diagnosis for non-ST elevation myocardial infarction (NSTEMI), demonstrating high accuracy and sensitivity in a Chinese cohort. This strategy is recommended for optimal diagnostic performance.

Area of Science:

  • Cardiology
  • Biomarker Assay Development
  • Diagnostic Strategies

Background:

  • Acute coronary syndrome (ACS) encompasses conditions like unstable angina, NSTEMI, and STEMI.
  • High-sensitivity cardiac troponin I (hs-cTnI) assays are recommended for NSTEMI diagnosis due to high sensitivity and specificity.
  • Optimal early NSTEMI detection strategies using hs-cTnI assays lack consensus.

Purpose of the Study:

  • To evaluate the diagnostic performance of four hs-cTnI-based strategies for suspected NSTEMI.
  • To compare the performance of different hs-cTnI assay manufacturers.
  • To identify the most reliable hs-cTnI strategy for early NSTEMI diagnosis in a Chinese cohort.

Main Methods:

  • Performance verification of hs-cTnI assays, including Limit of Detection (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), and precision analysis.
  • Analysis of clinical samples from 267 ACS patients using Hybiome hs-cTnI assays.
  • Assessment of diagnostic accuracy using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score for four strategies: LoB, Single Cut-off, hs-cTnI 0/1 h Algorithm, and hs-cTnI 0/2 h Algorithm.

Main Results:

  • The LoB strategy showed 100% sensitivity but a low PPV (14.0%).
  • Both the hs-cTnI 0/1 h and 0/2 h Algorithms demonstrated high diagnostic performance.
  • The hs-cTnI 0/2 h Algorithm achieved the best overall performance with 89.0% accuracy, 93.3% sensitivity, and a 73.68% F1-score.

Conclusions:

  • The hs-cTnI 0/2 h Algorithm offers the most reliable diagnostic performance for early NSTEMI detection.
  • This algorithm provides a robust strategy for improving the accuracy of NSTEMI diagnosis.
  • Further validation across diverse populations may be beneficial.

Keywords:
Diagnostic strategyNSTEMIhs-cTnI

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