SARS-CoV-2 COVID-19 CLIA Assay Real-Time PCR Serological Analysis Coronavirus Diagnostics

Abstract\nText SARS – CoV-2 is a pathogenic coronavirus which continuously evolve as changes in the genetic code occur during replication of the genome. Real-Time PCR analysis is the main standard for identification of SARS-CoV-2- infection. Because there are limits in its utilization for large-scale screening, serological assays have been used for detecting SARS-CoV-2 presence. \nThe aim of this study is to compare and highlight the efficiency of these methods in COVID-19 diagnostics. Nasopharyngeal samples were collected from 1198 patients which were analyzed after with RT-PCR. 90 of these patients resulted positive with SARS-CoV-2 virus and 55 of them were subjected to CLIA serological assay. As a result, 49 (89.1%) patients were positive only for IgG, 4 (7.3%) patients were positive for both antibodies IgG and IgM and only 2(3.6%) patients were negative for both antibodies, based on serological results. However, both assays had better performance 8-10 days after symptoms appearance, meanwhile the serological assay was more predictable at least 10 days after symptoms appearance. The serological assay used in this study helps in a better monitoring of the patients whom resulted positive with RT-PCR, especially to define the infection stage. As a conclusion, serological assay is limited in usefulness when diagnosing SARS-CoV-2 infection but it is useful to provide information in patient’s immunoreaction to COVID-19 exposure. A combination of both molecular analysis and serological assays is the most effective way to diagnose this virus.　\nKeywords: SARS-CoV-2; Covid-19; CLIA serological assay; RT-PCR

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