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Evaluation of the analytical and clinical performance of a new high-sensitivity cardiac troponin I assay: hs-cTnI (CLIA) assay

  • Ling Li , Xin Shu , Litao Zhang ORCID logo , Ao Xu , Juan Yang , Yisha Jing , Hui Wang and Zhenlu Zhang EMAIL logo
Published/Copyright: September 26, 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 62 Issue 2

Abstract

Objectives

Cardiac troponin (cTn) is the key biomarker for diagnosis of acute coronary syndrome (ACS). We performed a complete assessment of the high-sensitivity cardiac troponin I (hs-cTnI) (CLIA) assay on the analytical performance and clinical diagnostic performance, which was compared with Abbott ARCHITECT hs-cTnI assay.

Methods

Sex-specific 99th percentile upper reference limits (URLs) were determined from a healthy population of 424 males and 408 females. High-sensitivity performance was assessed by examining the imprecision at sex-specific URLs and the detectable results above LoD in a cohort of healthy population. The diagnostic performance of the hs-cTnI (CLIA) assay was validated in a population of 934 patients with suspected ACS.

Results

The 99th percentile URLs were 15.3 ng/L for female, 31.3 ng/L for male and 24.2 ng/L for overall population. The total imprecision near the sex-specific 99th percentile URLs were <5 %. 76.74 % of females, 97.12 % of males and 86.69 % of overall population had cTnI values exceeding the LoD, which met the criteria of high-sensitivity troponin assay. No cross-reactivity or interference was identified. The diagnostic sensitivity, specificity, PPV, NPV, and AUC of hs-cTnI (CLIA) assay were 97.97 , 90.70, 79.02, 99.21 % and 0.9885, respectively, which were comparable to ARCHITECT hs-cTnI assay.

Conclusions

hs-cTnI (CLIA) assay is a high-sensitivity troponin I method with high precision, sensitivity and specificity. The clinical diagnostic performance of hs-cTnI (CLIA) is comparable to the established ARCHITECT hs-cTnI assay. Mindray’s hs-cTnI (CLIA) assay is an attractive alternative for diagnosis of myocardial infarction with a high level of accuracy and safety.

Keywords: high-sensitivity; cardiac troponin I; chemiluminescence immunoassay; myocardial infarction; analytical performance; diagnostic performance
Corresponding author: Dr. Zhenlu Zhang, Clinical Laboratory of Wuhan Asia Heart Hospital, 432000, Wuhan, Hubei, P.R. China, E-mail:
Ling Li and Xin Shu contributed equally to this work.

Funding source: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

  1. Research ethics: The present study carried out at Wuhan Asia Heart hospital (Wuhan, Hubei province, China) was approved by the Ethics Committee in accordance with the Helsinki Declaration.

  2. Informed consent: Not applicable.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: The authors declare that there is no conflict of interest.

  5. Research funding: This project was supported by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for financial support. Financial support was not dependent on the results of the study.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2023-0529).

Received: 2023-05-19
Accepted: 2023-08-25
Published Online: 2023-09-26
Published in Print: 2024-01-26

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2023-0529
Keywords for this article
high-sensitivity; cardiac troponin I; chemiluminescence immunoassay; myocardial infarction; analytical performance; diagnostic performance

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Rapid rule-in and rule-out protocols of acute myocardial infarction using hs-cTnI and hs-cTnT methods
  4. Reviews
  5. A guide to conducting systematic reviews of clinical laboratory tests
  6. Improving diagnosis and treatment of hypomagnesemia
  7. Opininon Paper
  8. Documenting and validating metrological traceability of serum alanine aminotransferase measurements: a priority for medical laboratory community for providing high quality service in hepatology
  9. EFLM Paper
  10. Assessing the status of European laboratories in evaluating biomarkers for chronic kidney diseases (CKD) and recommendations for improvement: insights from the 2022 EFLM Task Group on CKD survey
  11. General Clinical Chemistry and Laboratory Medicine
  12. Bland and Altman agreement method: to plot differences against means or differences against standard? An endless tale?
  13. Assessment of three equations to calculate plasma LDL cholesterol concentration in fasting and non-fasting hypertriglyceridemic patients
  14. Validation of metrological traceability of the new generation of Abbott Alinity alkaline phosphatase assay
  15. Quality assurance programs for vitamin A and E in serum: are we doing enough to assess laboratory performance?
  16. A supervised machine-learning approach for the efficient development of a multi method (LC-MS) for a large number of drugs and subsets thereof: focus on oral antitumor agents
  17. Performance evaluation of alternate ESR measurement method using BC-780 automated hematology analyzer: a comparison study with the Westergren reference method
  18. Total error in lymphocyte subpopulations by flow cytometry-based in state of the art using Spanish EQAS data
  19. Development and multi-center validation of a fully automated digital immunoassay for neurofilament light chain: toward a clinical blood test for neuronal injury
  20. CSF and plasma Aβ42/40 across Alzheimer’s disease continuum: comparison of two ultrasensitive Simoa® assays targeting distinct amyloid regions
  21. Improving regional medical laboratory center report quality through a report recall management system
  22. Cardiovascular Diseases
  23. Evaluation of the analytical and clinical performance of a new high-sensitivity cardiac troponin I assay: hs-cTnI (CLIA) assay
  24. Hemodialysis and biomarkers of myocardial infarction – a cohort study
  25. Letters to the Editor
  26. Chatbot GPT can be grossly inaccurate
  27. Blood collection in heparin vs. EDTA results in an inflammasome-independent increase in monocyte distribution width at 4 h
  28. Week-to-week within-subject and between-subject biological variation of copeptin
  29. The effect of unintended shortage in technical resources on the quality of endpoint clinical laboratory diagnosis
  30. Epigenetic signatures of cfDNA enable a topological assignment of tissue damage
  31. Six Sigma driven QC in antibody testing for infectious diseases
  32. Extensive analytical evaluation of the performances of the new DiaSys PCT assay and comparison with Elecsys B·R·A·H·M·S PCT test on Roche Cobas and B·R·A·H·M·S PCT-sensitive Kryptor
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  36. Blood plasma biomarkers for Alzheimer’s disease: Aβ1–42/1–40 vs. AβX–42/X–40
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