商用血清肌钙蛋白快速检测试剂盒的性能分析

Q4 Medicine
Raquel Ida Ferreira, Marcela R. Amaral, Maytê S. R. Brito, Matheus P. Pinto, Ana Carolina R. Maranhão, Lucas Costa, Rómulo Melo
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引用次数: 0

摘要

简介:快速检测是一种重要的诊断工具,可在短时间内提供结果,无需使用大型自动化设备。目的:评价5种血清肌钙蛋白I快速检测试剂盒的性能。材料与方法:选取巴西MG Barbacena某医院100例疑似急性心肌梗死(AMI)患者标本。用5种肌钙蛋白I快速检测试剂盒进行检测,并与研究参考方法(定量化学发光免疫分析法)进行比较。定义快速试验与参考方法的敏感性、特异性、阳性预测值(PPV)、阴性预测值(NPV)和相关系数。结果:Abon®、Interteck®、Medtest®和Wama®的试剂盒表现相同,灵敏度(98.08%)、特异度(100%)、PPV(100%)、NPV(97.96%)、相关系数(0.99)均达到相同水平。Eco diagnostics®试剂盒的灵敏度较低(82.69%),相关系数较低(0.91),NPV(84.21%),即使处于置信区间内,也未达到理想水平。讨论:使用Abon®、Interteck®、Medtest®和Wama®检测试剂盒获得的结果证实了肌钙蛋白检测快速检测诊断准确性的已有文献数据。这些测试允许医生立即做出决定,并可用于减少与疑似AMI相关的不必要住院时间和费用。结论:Abon®、Interteck®、Medtest®和Wama®的试剂盒具有优异的诊断性能,是没有自动化设备的小型实验室的重要诊断工具。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Performance analysis of commercial rapid tests for serum troponin detection
Introduction: Rapid tests represent an important diagnostic tool, providing results in a short period of time and eliminating the use of large automated equipment. Objective: To evaluate the performance of five rapid test kits for troponin I detection in serum. Materials and methods: Samples from 100 patients with suspected acute myocardial infarction (AMI) were selected from a hospital in Barbacena, MG, Brazil. They were tested in the five troponin I commercial rapid test kits and the results were compared with the study reference method (quantitative chemiluminescent immunoassay). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and correlation coefficients of the rapid tests against the reference method were defined. Results: The kits from Abon ® , Interteck ® , Medtest ® and Wama ® presented the same performance, reaching equal levels of sensitivity (98.08%), specificity (100%), PPV (100%), NPV (97.96%), and correlation coefficient (0.99). The Eco Diagnostica ® kit presented lower sensitivity (82.69%), low correlation coefficient (0.91) and NPV (84.21%), not reaching ideal levels even though lying within the confidence interval. Discussion: The results obtained with the Abon ® , Interteck ® , Medtest ® and Wama ® test kits corroborate pre-existing literature data on the diagnostic accuracy of rapid tests for troponin detection. These tests are allowed for immediate decision making by physicians and can be used to reduce unnecessary hospitalization time and costs associated with a suspected AMI. Conclusion: The kits from Abon ® , Interteck ® , Medtest ® and Wama ® showed excellent diagnostic performance, what makes them an important diagnostic tool in smaller laboratories without automated equipment.
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来源期刊
Jornal Brasileiro de Patologia e Medicina Laboratorial
Jornal Brasileiro de Patologia e Medicina Laboratorial Health Professions-Medical Laboratory Technology
CiteScore
1.30
自引率
0.00%
发文量
0
审稿时长
20 weeks
期刊介绍: The Jornal Brasileiro de Patologia e Medicina Laboratorial (Brazilian Journal of Pathology and Laboratory Medicine), a continuation of Jornal Brasileiro de Patologia (Brazilian Journal of Pathology), and published quarterly (March, June, September and December) is directed towards the publication of scientific articles that contribute to the development of the area of Laboratory Medicine (Clinical Pathology, Pathology, Cytopathology). It accepts the following categories of articles: original articles, review articles, case reports, short communications, updating articles, letters to editors and reviews.
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