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Novel Mindray high sensitivity cardiac troponin I assay for single sample and 0/2-hour rule out of myocardial infarction: MERITnI study

  • Kevin G. Buda , Yader Sandoval , Stephen W. Smith , Barrett Wagner , Karen Schulz , Anne Sexter and Fred S. Apple EMAIL logo
Published/Copyright: March 25, 2025
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 8

Abstract

Objectives

We determined the efficacy of a high sensitivity cardiac troponin I (hs-cTnI) assay for newly derived 0 h and 0/2-h rule-out concentrations for myocardial infarction and determined the safety of incremental changes at low concentrations.

Methods

Consecutive, emergency department patients undergoing serial hs-cTnI testing on clinical indication were studied in the ‘Mindray hs-cTnI Assay Analytical and Clinical Evaluation for the Diagnosis and RIsk Assessment of Myocardial InfarctIon’ (MERITnI) trial. Primary safety outcome was the composite of cardiac death and MI at 30 days.

Results

In 1,556 patients (60.7 % male, 43.3 % White, 45.8 % Black. 34.8 % chest pain), 26.9 % patients had at least one hs-cTnI >99th percentile. 2.7 % had type 1 MI, 2.7 % type 2 MI, and 21.5 % non-MI myocardial injury. Single-sample MI rule-out using a normal ECG plus hs-cTnI of <2 ng/L (rounded) ruled out 13.8 % of patients, including early (<2 h) presenters. A 2-h delta of <2 ng/L ruled out an additional 39 % of patients. Based on European Society of Cardiology guidance, derived 0 h<15 ng/L and derived delta of <5 ng/L ruled out 42 % of patients. The Mindray assay showed incremental (non-rounded) analysis discriminated rule out from baseline of <0.1 ng/L at 1.2 % to 2.0 ng/L at 17.0 %. There were no missed adverse outcomes at 30-day assessment for composite of MI and cardiac death.

Conclusions

The novel Mindray hs-cTnI assay enabled safe and early rule out of MI and cardiac death at very low concentrations in a diverse, cohort utilizing both single sample and 0/2-h rule out protocols, including early presenters.

Keywords: myocardial infarction; cardiac troponin; early rule out; risk outcomes
Corresponding author: Fred S. Apple, PhD, Hennepin Healthcare/HCMC, Research Institute, Clinical Laboratories P4, 701 Park Ave, Minneapolis, MN 55415, USA; Department of Laboratory Medicine & Pathology, Hennepin Healthcare, Minneapolis, MN, USA; and Department of Laboratory Medicine & Pathology, University of Minnesota School of Medicine, Minneapolis MN USA, E-mail:

Funding source: Mindray

Award Identifier / Grant number: NA

Funding source: Hennepin Healthcare Research Institute

Award Identifier / Grant number: NA

  1. Research ethics: The Mindray hs-cTnI Assay Analytical and Clinical Evaluation for the Diagnosis and RIsk Assessment of Myocardial InfarctIon’ (MERITnI, NCT05853042) trial is an observational cohort study that was approved by the Hennepin Healthcare Institutional Review Board, with all participants acknowledging consent at presentation and registration in the emergency department (ED).

  2. Informed consent: The Mindray hs-cTnI Assay Analytical and Clinical Evaluation for the Diagnosis and RIsk Assessment of Myocardial InfarctIon’ (MERITnI, NCT05853042) trial is an observational cohort study that was approved by the Hennepin Healthcare Institutional Review Board, with all participants acknowledging consent at presentation and registration in the emergency department (ED).

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

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: Yader Sandoval: Abbott (consultant, advisory board), Roche (consultant, advisory board, speaker), GE Healthcare (consultant, advisory board), Philips (consultant, advisory board speaker), Zoll (advisory board), JACC Advances (associate editor), patent 20210401347. Stephen Smith: shareholder of Powerful Medical (Artificial Intelligence ECG Interpretation). Fred S. Apple: Associate Editor, Clinical Chemistry; Advisory Boards, Werfen; Consultant, Mindray; PI on Industry Funded Grants (non-salaried) on cardiac biomarkers through hospital research institute (HHRI): Abbott Diagnostics, Abbott POC, BD, Beckman Coulter, Ortho-Clinical Diagnostics, Roche Diagnostics, Siemens Healthineers, Quidel/Ortho. Karen Schulz: PI on Industry Funded Grant (non-salaried) on cardiac biomarkers through hospital research institute (HHRI): Mindray. Anne Sexter, Barrett Wagner and Kevin Buda have nothing to disclose.

  6. Research funding: The MERITnI (NCT05853042) study was partially funded through a) an investigator (FSA) initiated grant from Mindray, who had no role in the design and conduction of the study; including data collection, management, analysis, and interpretation of the data or preparation, review, or approval of the final manuscript; and b) financial assistance from the Hennepin Healthcare Research Institute (HHRI) Cardiac Biomarkers Trials Laboratory.

  7. Data availability: On appropriate request.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-1387).

Received: 2024-11-26
Accepted: 2025-03-12
Published Online: 2025-03-25
Published in Print: 2025-07-28

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-1387
Keywords for this article
myocardial infarction; cardiac troponin; early rule out; risk outcomes

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Setting analytical performance specification by simulation (Milan model 1b)
  4. Reviews
  5. Unveiling the power of R: a comprehensive perspective for laboratory medicine data analysis
  6. Clostebol detection after transdermal and transmucosal contact. A systematic review
  7. Opinion Papers
  8. A value-based score for clinical laboratories: promoting the work of the new EFLM committee
  9. Digital metrology in laboratory medicine: a call for bringing order to chaos to facilitate precision diagnostics
  10. Perspectives
  11. Supporting prioritization efforts of higher-order reference providers using evidence from the Joint Committee for Traceability in Laboratory Medicine database
  12. Clinical vs. statistical significance: considerations for clinical laboratories
  13. Genetics and Molecular Diagnostics
  14. Reliable detection of sex chromosome abnormalities by quantitative fluorescence polymerase chain reaction
  15. Targeted proteomics of serum IGF-I, -II, IGFBP-2, -3, -4, -5, -6 and ALS
  16. Candidate Reference Measurement Procedures and Materials
  17. Liquid chromatography tandem mass spectrometry (LC-MS/MS) candidate reference measurement procedure for urine albumin
  18. General Clinical Chemistry and Laboratory Medicine
  19. Patient risk management in laboratory medicine: an international survey to assess the severity of harm associated with erroneous reported results
  20. Exploring the extent of post-analytical errors, with a focus on transcription errors – an intervention within the VIPVIZA study
  21. A survey on measurement and reporting of total testosterone, sex hormone-binding globulin and free testosterone in clinical laboratories in Europe
  22. Quality indicators in laboratory medicine: a 2020–2023 experience in a Chinese province
  23. Impact of delayed centrifugation on the stability of 32 biochemical analytes in blood samples collected in serum gel tubes and stored at room temperature
  24. Concordance between the updated Elecsys cerebrospinal fluid immunoassays and amyloid positron emission tomography for Alzheimer’s disease assessment: findings from the Apollo study
  25. Novel protocol for metabolomics data normalization and biomarker discovery in human tears
  26. Use of the BIOGROUP® French laboratories database to conduct CKD observational studies: a pilot EPI-CKD1 study
  27. Reference Values and Biological Variations
  28. Consensus instability equations for routine coagulation tests
  29. Hematology and Coagulation
  30. Flow-cytometric lymphocyte subsets enumeration: comparison of single/dual-platform method in clinical laboratory with dual-platform extended PanLeucogating method in reference laboratory
  31. Cardiovascular Diseases
  32. Novel Mindray high sensitivity cardiac troponin I assay for single sample and 0/2-hour rule out of myocardial infarction: MERITnI study
  33. Infectious Diseases
  34. Cell population data for early detection of sepsis in patients with suspected infection in the emergency department
  35. Letters to the Editor
  36. Lab Error Finder: A call for collaboration
  37. Cascading referencing of terms and definitions
  38. Strengthening international cooperation and confidence in the field of laboratory medicine by ISO standardization
  39. Determining the minimum blood volume required for laboratory testing in newborns
  40. Performance evaluation of large language models with chain-of-thought reasoning ability in clinical laboratory case interpretation
  41. Vancomycin assay interference: low-level IgM paraprotein disrupts Siemens Atellica® CH VANC assay
  42. Dr. Morley Donald Hollenberg. An extraordinary scientist, teacher and mentor
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