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.

IF 3.8 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry and laboratory medicine Pub Date : 2025-02-10 DOI:10.1515/cclm-2024-1373

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

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引用次数: 0

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.

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来源期刊

Clinical chemistry and laboratory medicine 医学-医学实验技术

CiteScore

11.30

自引率

16.20%

发文量

306

审稿时长

3 months

期刊介绍： Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!