Clinical Performance of Two Methods for Detecting Anti SARS-CoV-2 Antibodies

D. Jacobsen, D. Gonzalez, J. Jamardo, B. Perazzi, Repetto Em, B. Fabre, C. Ibar, L. Pugliese, F. Fortuna, E. Carrizo, Caro Em, G. Reboredo, Argentina Coordinadora de Salud Misionar, Argentina Biogenar Laboratorio
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Abstract

Evaluating the clinical performance of available methods to detect antibodies against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has become a primordial issue in clinical laboratories. The aim of this study was to evaluate the clinical performance of two methods for SARS-CoV-2 antibodies detection, an automated Chemiluminescent Immunoassay (CLIA) and an immunochromatographic Lateral-Flow Assay (LFA) in patients with positive reverse transcription polymerase chain reaction (RT-PCR). Performance for CLIA method was Positive Agreement (PA) 56.6% and Negative Agreement (NA) 96,6% for IgM and PA 85.8%/NA 90,2% for IgG. Performance for LFA method was PA 56.2% and NA 100% for IgM and PA 95.5% and NA 100 % for IgG. LFA general agreement IgG was better than CLIA. In both methods, significant differences in Kappa index are observed when IgG and IgM are compared. When evaluating the data from a clinical perspective, we found that both method performance for IgM detection may not meet the expected requirements for their clinical utility and could lead to an inappropriate medical decision. The findings of this study show that both immunoassay methods might be reliable for assessing immunological response in COVID-19 patients. Our results also confirm that IgG measurement could be helpful, especially for epidemiological studies in our population. These results provide evidence to justify epidemiological studies in our population.
两种抗SARS-CoV-2抗体检测方法的临床性能
评估现有检测SARS-CoV-2抗体方法的临床性能已成为临床实验室的首要问题。本研究的目的是评估两种检测SARS-CoV-2抗体的方法,自动化学发光免疫分析法(CLIA)和免疫层析横向流分析法(LFA)在逆转录聚合酶链反应(RT-PCR)阳性患者中的临床表现。CLIA法对IgM的检测结果为阳性(PA) 56.6%,阴性(NA) 96.6%,对IgG的检测结果为PA 85.8%/NA 90.9%。LFA法对IgM的检测效果为PA 56.2%, NA 100%;对IgG的检测效果为PA 95.5%, NA 100%。LFA总协定IgG优于CLIA。在两种方法中,比较IgG和IgM时Kappa指数有显著差异。当从临床角度评估数据时,我们发现这两种方法的IgM检测性能可能不符合其临床用途的预期要求,并可能导致不适当的医疗决策。本研究结果表明,这两种免疫测定方法可能是评估COVID-19患者免疫反应的可靠方法。我们的结果也证实了IgG的测量可能是有帮助的,特别是对我们人群的流行病学研究。这些结果为在我国人群中进行流行病学研究提供了证据。
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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