Diagnostic performance of Mindray CL1200i high sensitivity cardiac troponin I assay compared to Abbott Alinity cardiac troponin I assay for the diagnosis of type 1 and 2 acute myocardial infarction in females and males: MERITnI study

Fred S. Apple; Kevin G. Buda; Barrett P. Wagner; Anne Sexter; Yader Sandoval; Stephen W. Smith; Kylie Meyer; Alanna Ladd; Kathryn Worrell; Hannah M. Brown; Karen M. Schulz

doi:10.1515/cclm-2024-1373

Article

Diagnostic performance of Mindray CL1200i high sensitivity cardiac troponin I assay compared to Abbott Alinity cardiac troponin I assay for the diagnosis of type 1 and 2 acute myocardial infarction in females and males: MERITnI study

Fred S. Apple , Kevin G. Buda , Barrett P. Wagner , Anne Sexter , Yader Sandoval , Stephen W. Smith , Kylie Meyer , Alanna Ladd , Kathryn Worrell , Hannah M. Brown and Karen M. Schulz

Published/Copyright: February 10, 2025

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 6

Abstract

Objectives

We examined the 0- and 2-h diagnostic performance of the Mindray high-sensitivity cardiac troponin I (hs-cTnI) assay using two predefined sex-specific 99th percentile upper reference limits (URL) in patients with normal electrocardiograms to aid in the diagnosis of myocardial infarction (MI).

Methods

Consecutive emergency department patients undergoing serial high-sensitivity cardiac troponin I (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 (NCT05853042). Plasma hs-cTnI testing was performed using Mindray CL1200i (investigational) and Abbott Alinity (clinical) assays.

Results

In 1,556 patients (60.7 % male, 43.3 % White, 45.8 % Black, 34.8 % chest pain), 2.7 % had type 1 MI, 2.7 % type 2 MI, and 21.5 % non-MI myocardial injury. At 0 h for all MIs (n=86), using package insert URLs and Universal Sample Bank (USB) URLs, sensitivities were 83.7 and 93.0 %. At 0/2 h for all MIs with package insert and USB URLs, sensitivities were higher with serial testing, at 95.3 and 97.7 %. Negative predictive value (NPVs) were excellent and similar for both URLs, ranging from 98 to 100 %. Substantial hs-cTnI concentration differences were observed between sex and injury types. Alinity hs-cTnI diagnostic observations were similar for both package insert and USB URLs.

Conclusions

The Mindray CL1200i hs-cTnI assay provides the relevant clinical diagnostic information to enable clinicians to deliver cost-effective care for patients to aid in the diagnosis of MI predicated on 0- and 2-h serial testing based on sex-specific 99th percentiles. Novel observations were observed for findings based on different URLs and for females and MI types.

Keywords: cardiac troponin; myocardial infarction; diagnostics; biomarkers; sex-specific 99th percentile

Corresponding author: Fred S. Apple, PhD, Hennepin Healthcare Research Institute, Minneapolis, MN, USA, Department of Laboratory Medicine & Pathology, Hennepin Healthcare/HCMC, Minneapolis, MN, USA, Department of Laboratory Medicine & Pathology, University of Minnesota School of Medicine, Minneapolis, MN, USA; and Hennepin County Medical Center, Clinical Laboratories P4, 701 Park Avenue, Minneapolis, MN 55415, USA, E-mail: apple004@umn.edu

Funding source: Mindray PI initiated study

Award Identifier / Grant number: NA

Research ethics: The ‘Mindray hs-cTnI Assay Analytical and Clinical Evaluation for the Diagnosis and RIsk Assessment of Myocardial InfarctIon’ (MERITnI, NCT05853042) trial was an observational cohort study that was approved by the Hennepin Healthcare Institutional Review Board.
Informed consent: The ‘Mindray hs-cTnI Assay Analytical and Clinical Evaluation for the Diagnosis and RIsk Assessment of Myocardial InfarctIon’ (MERITnI, NCT05853042) trial was 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).
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission
Use of Large Language Models, AI and Machine Learning Tools: None declared.
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), CathWorks (consultant), Cleerly (speaker), HeartFlow (speaker) and JACC Advances (associate editor). He and others hold 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 Hennepin Healthcare 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 biomarker studies through Hennepin Healthcare Research Institute. Hannah Brown: PI on Industry funded grants (non-salaried) on non-cardiac biomarker studies through Hennepin Healthcare Research Institute. Anne Sexter, Barrett P. Wagner, Kevin G. Buda, Kylie Meyer, Alanna Ladd, and Kathryn Worrell have nothing to disclose.
Research funding: The MERITnI (NCT05853042) study was partially funded through a) an investigator (FSA; KMS) 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 Biomarker Trials Laboratory.
Data availability: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Received: 2024-11-22

Accepted: 2025-01-29

Published Online: 2025-02-10

Published in Print: 2025-05-26

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Articles in the same Issue

https://doi.org/10.1515/cclm-2024-1373

Keywords for this article

cardiac troponin; myocardial infarction; diagnostics; biomarkers; sex-specific 99th percentile