Assay precision, 99th percentile reference value and proportion of detected healthy european adults for VIDAS® high-sensitive troponin I.

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine Pub Date : 2024-11-29 eCollection Date: 2024-11-01 DOI:10.1016/j.plabm.2024.e00441

Nathalie Auberger, Isabelle Coin, Laure Marillet, Frédérique Raymond, Sandrine Michel-Busseret, Pierre-Géraud Claret, Camille Pease

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引用次数: 0

Abstract

Introduction/objectives: Following the IFCC (The International Federation of Clinical Chemistry and Laboratory Medicine) guidelines concerning high-sensitivity cardiac troponin assays, we performed an assessment of the VIDAS® High-Sensitive Troponin I (TNHS) assay. The test was evaluated on its capacity to detect at least 50 % of healthy individuals and checked that the coefficient of variation was less than 10 % at the 99th percentile.

Methods: High-sensitivity performance was assessed by examining the limits of detection, the determination of the 99th percentile value, the evaluated imprecision at said value and the detectable results above limit of detection (LoD) in a cohort of healthy European individuals. The capacity of detection on a healthy population of VIDAS® TNHS was validated on a total of 808 plasma samples.

Results: One thousand six hundred and nineteen values (888 values for male samples and 731 values for female samples) were included in the analysis. The total imprecision of VIDAS® High-Sensitive Troponin I assay at the 99th percentile was 5.2 %, and 57.4 % of healthy individuals had troponin I values exceeding the LoD. Since the test detected more than 50 % of healthy individuals and had a coefficient of variation less than 10 % at the 99th percentile, it met the criteria of high-sensitivity cardiac troponin assays.

Conclusion: VIDAS® High-Sensitive Troponin I assay is a high-sensitivity cardiac troponin assays meeting the definition provided by IFCC guidelines.

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VIDAS®高敏感肌钙蛋白I的检测精度、99百分位参考值和检测到的健康欧洲成年人比例。

简介/目的：根据IFCC（国际临床化学和检验医学联合会）关于高灵敏度心肌肌钙蛋白检测的指南，我们对VIDAS®高灵敏度肌钙蛋白I （TNHS）检测进行了评估。评估了该测试至少检测50%健康个体的能力，并在第99个百分位数检查变异系数小于10%。方法：通过检查检测限、测定第99百分位值、在该值处的评价不精确度和检测结果高于检测限（LoD）对欧洲健康人群进行高灵敏度评价。在总共808份血浆样本上验证了VIDAS®TNHS在健康人群中的检测能力。结果：共纳入1619个值，其中男性样本888个，女性样本731个。VIDAS®高敏感肌钙蛋白I检测在第99百分位的总不精确性为5.2%，57.4%的健康个体的肌钙蛋白I值超过LoD。由于该测试检测到超过50%的健康个体，并且在第99百分位数的变异系数小于10%，因此它符合高灵敏度心肌肌钙蛋白检测的标准。结论：VIDAS®高灵敏度肌钙蛋白I检测是一种高灵敏度心肌肌钙蛋白检测，符合IFCC指南提供的定义。

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

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.