评估用于确定 SARS-CoV-2 感染者免疫球蛋白状态的血清学测定，发现其性能低下

International Journal of Health Sciences and Research Pub Date : 2024-07-10 DOI:10.52403/ijhsr.20240732

Samira Zoa Assoumou, Berthe A. Iroungou, Krystina Mengue Me Ngou-Milama

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引用次数: 0

摘要

导言：SARS-CoV-2 的出现促进了几种抗体检测血清学试验的发展。在使用前需要对其性能进行外部评估。本研究旨在评估用于检测 IgM/IgG 抗体 SARS-CoV-2 的商用侧流设备的性能：方法：使用 122 份经 RT-PCR 检测呈 SARS-CoV-2 阳性的样本。血清学检测（Ichroma2 COVID-19 Ab 试剂盒）作为金标准。所有这些样本都是在发病后 14 天以上进行检测的。在使用金标准检测后的 122 份样本中，41 份样本 IgM / IgG 阳性，43 份样本 IgM 阳性 / IgG 阴性，38 份样本 IgM 阴性 / igG 阳性：所评估的商业检测对 IgM 的敏感性和特异性分别为 2.4%（95% 置信区间 [CI]：0.0%-5.7%）和 100%，对 IgG 的敏感性和特异性分别为 10.1%（95% 置信区间 [CI]：3.5%-16.8%）和 100%：结论：我们的研究结果表明，在实施前对检测方法的性能进行评估至关重要：[血清学方法免疫层析性能 SARS-CoV-2、COVID-19］

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Evaluation of a Serological Assay to Determine the Immunoglobulin Status in SARS-CoV-2 Infected Patients Reveals a Low Performance

Introduction: Emergence of SARS‐CoV‐2 has promoted the development of several serological tests for antibody detection. The external evaluation of their performance is needed before use. This study aims at assessing the performance of a Commercial lateral flow device for IgM/IgG Antibody SARS-CoV-2 detection. Methods: One‐hundred twenty-two samples SARS-CoV-2 positive by RT-PCR were used. A serological test (Ichroma2 COVID-19 Ab kit) was used as gold standard. All these samples were tested > 14 day post symptoms onset. Among the 122 samples used after testing with gold standard: 41 were IgM / IgG positive, 43 IgM positive / IgG negative and 38 IgM negative / igG positive. Results: The commercial test evaluated shows a sensitivity and specificity of 2.4% (95% confidence interval [CI]: 0.0%-5.7%) and 100% for IgM and 10.1% (95% confidence interval [CI]: 3.5%-16.8%) and 100% for IgG. Conclusion: Our findings demonstrate the crucial importance to evaluate performance of an assay before implementing. Key words: [Serological methods, Immunochromatography, performance, SARS-CoV-2, COVID-19]

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International Journal of Health Sciences and Research

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