Review of Clinical Performance of Serology Based Commercial Diagnostic Assays for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Antibodies.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, which caused the coronavirus disease 2019 (COVID-19) pandemic as declared by the World Health Organization, has created havoc worldwide. The highly transmissible infection can be contained only by accurate diagnosis, quarantining, and exercising social distancing. Therefore, quick and massive deployment of SARS-CoV-2 testing plays a crucial role in the identification and isolation of infected patients. Reverse transcription-polymerase chain reaction is the gold standard for COVID-19 detection; however, it needs expertise, facilities, and time. Hence, for the ease of population-wide screening, serology-based diagnostic assays were introduced. These can help determine the prevalence of infection, understand the epidemiology of the disease, and assist in suitable public health interventions while being user-friendly and less time consuming. Although serological testing kits in markets soared, their sensitivity and specificity were questioned in reports from different parts of the world. In this article, we have reviewed 40 Food and Drug Administration (FDA) and CE-approved clinically evaluated serological kits (8 enzyme-linked immunosorbent assay [ELISA] kits, 10 chemiluminescent immunoassay [CLIA] kits, and 22 lateral flow immunoassay [LFIA] kits) for their sensitivity and specificity and discussed the apparent reasons behind their performance. We observed appreciable sensitivity in the kits detecting total antibodies compared to the kits targeting single isotype antibodies. Tests that determined antibodies against nucleocapsid protein were found to be more sensitive and those detecting antibodies against spike protein were found to have greater specificity. This study was conducted to help the decision-making while acquiring antibody kits and concurrently to be mindful of their shortcomings.