Validation of a chemiluminescent assay for specific SARS-CoV-2 antibody
Validation of a chemiluminescent assay for specific SARS-CoV-2 antibody
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DOI：
10.1515/cclm-2020-0594
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发表时间：
2020-08-01
影响因子：
6.8
通讯作者：
Blairon, Laurent
中科院分区：
文献类型：
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作者：
Tre-Hardy, Marie;Wilmet, Alain;Blairon, Laurent
目标：面对COVID-19大流行及其对治疗和诊断方法的可用性和质量的影响，比利时当局决定启动一项程序，对在国家领土上出售的血清学检测的性能进行额外评估。提出这一建议有双重目的：(1)对制造商提供的分析和临床性能进行深入验证，(2)在使用评估测试的所有实验室进行集中验证方面实现规模经济。方法：对125例患者的血清进行回顾性验证研究，以确定DiaSorin (R)公司的LIAISON (R) SARS-CoV-2检测抗SARS-CoV-2 IgG的分析和临床性能，并将其临床性能与euroimmune (R)公司的酶联免疫吸附试验（ELISA）进行比较，后者是首批可用于检测抗SARS-CoV-2 IgA和IgG的市售试验之一。结果：LIAISON (R) SARS-CoV-2的性能满足所有验收标准，提供的“真实世界”分析和临床性能与制造商在其插入试剂盒中报告的性能非常接近。对LIAISON (R) SARS-CoV-2和ELISA法进行比较，两种方法在测定IgG的敏感性和特异性方面没有任何差异。结论：本研究证实了LIAISON (R) SARS-CoV-2能够检测特异性针对SARS-CoV-2的IgG抗体。分析和临床性能优异，测试的自动化提供了重要的速率，是吸收测试扩展的理想选择。
Objectives: Faced with the COVID-19 pandemic and its impact on the availability and quality of both therapeutic and diagnostic methods, the Belgian authorities have decided to launch a procedure for additional evaluation of the performance of serological tests offered for sale on the national territory. This has been proposed with a double aim: (1) an in-depth verification of the analytical and clinical performances presented by the manufacturer and (2) an economy of scale in terms of centralized validation for all the laboratories using the tests subject to evaluation.Methods: A retrospective validation study was conducted including the serum of 125 patients in order to determine the analytical and clinical performances of the LIAISON (R) SARS-CoV-2 from DiaSorin (R) detecting anti-SARS-CoV-2 IgG and to compare its clinical performance with the enzyme-linked immunosorbent assay (ELISA) test from Euroimmun (R), one of the first commercially available tests allowing the detection of anti-SARS-CoV-2 IgA and IgG.Results: The performances of the LIAISON (R) SARS-CoV-2 satisfied all the acceptance criteria and provided "real world" analytical and clinical performances very close to the ones reported by the manufacturer in its insert kit. Comparison between the LIAISON (R) SARS-CoV-2 and the ELISA method did not reveal any difference between the two techniques in terms of sensitivities and specificities regarding the determination of the IgG.Conclusions: This study reports the validation of the LIAISON (R) SARS-CoV-2 allowing to detect IgG antibodies specifically directed against SARS-CoV-2. The analytical and clinical performances are excellent, and the automation of the test offers important rates, ideal for absorbing an extension of testing.