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 3.7 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY Clinical chemistry and laboratory medicine Pub Date : 2025-02-10 Print Date: 2025-05-26 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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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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迈瑞CL1200i高灵敏度心肌肌钙蛋白I检测与雅培Alinity心肌肌钙蛋白I检测在诊断女性和男性1型和2型急性心肌梗死中的诊断性能：MERITnI研究

目的：我们检查了Mindray高灵敏度心肌肌钙蛋白I （hs-cTnI）检测在0和2小时的诊断性能，使用两个预定义的性别特异性99百分位参考上限（URL）在正常心电图患者中帮助诊断心肌梗死（MI）。方法：在“迈瑞hs-cTnI检测分析与临床评价心肌梗死诊断与风险评估”（MERITnI）试验（NCT05853042）中，对连续急诊患者进行临床适应症高灵敏度心肌肌钙蛋白I （hs-cTnI）检测。血浆hs-cTnI检测采用迈瑞CL1200i（研究性）和雅培Alinity（临床）检测。结果：在1556例患者中（男性60.7% %，白人43.3% %，黑人45.8% %，胸痛34.8% %），2.7 %为1型心肌梗死，2.7 %为2型心肌梗死，21.5 %为非心肌梗死心肌损伤。所有MIs （n=86）在0 h时，使用包装说明书url和通用样本库（USB） url，敏感性分别为83.7和93.0 %。在0/2 h时，对于所有带有包装插入和USB url的MIs，串行测试的灵敏度更高，分别为95.3和97.7% %。两个url的阴性预测值（npv）非常好，相似，范围从98到100 %。hs-cTnI浓度在性别和损伤类型之间存在显著差异。alityhs - ctni诊断观察结果对于包插入和USB url都是相似的。结论：迈瑞CL1200i hs-cTnI检测提供了相关的临床诊断信息，使临床医生能够为患者提供具有成本效益的护理，以基于性别特异性第99百分位数的0和2小时系列检测来帮助诊断心肌梗死。基于不同的url以及女性和MI类型，观察到新的观察结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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!