Sensitivity and Specificity of Gold Chromatography Immunoassays IgM/IgG Antibody Test for COVID-19: Review of the Current Literature

Abstract

Background: The World Health Organization recommends molecular tests Polymerase Chain Reaction (PCR) to the diagnosis of coronavirus disease of 2019 (COVID-19), which detect the Severe Acute Respiratory Syndrome (SARS-Coronavirus 2) virus RNA. However, these tests are expensive and give a high negative result. There were urgent medical and public health needs for early diagnosis and treatment to minimize the spread of COVID-19. This review aimed to summarize known to date information about the latest research progress of the sensitivity and specificity of rapid combined IgM/IgG antibody test to diagnose the pandemic novel coronavirus disease of 2019 (COVID-19).
Methods: Databases such as PubMed, Google Scholar, Science Direct, Web of Science electronic databases were search related articles published between January 23, 2020 and April 29, 2020, using the following search terms: “COVID19 or COVID-19,” “novel coronavirus,” “SARS CoV-2 or SARS CoV2,” “Rapid antibody test,” “IgM/IgG,” “sensitivity,” “specificity.”
Results: The review included eight clinical studies for a total of 782 patients with COVID-19 and 631 healthy controls. The sensitivity and specificity of gold chromatography immuno-assays (GCIAs) IgM/IgG rapid test vary greatly among published studies. Of the eight shortlisted studies, the IgM/IgG sensitivity ranged from 73.9% to 89.3% in six (75%) and the IgM/IgG specificity ranged from 88.9% to 100% in the eight (100%) reviewed studies. The pooled data revealed that the average sensitivity and specificity was 70% and 94.5%, respectively. They agreed on its simplicity, fastness, and fewer requirements.
Conclusion: The GCIAs IgM/IgG rapid tests are simply fast and safe. Besides their short turnaround time, no specific equipment or skilled  technicians’ requirements, they can serve as a rapid diagnostic test of RT–PCR-negative highly suspected patients and screening of SARS CoV-2 carriers. It cannot take the place of PCR, but the huge lab diagnosis pressure can be greatly relieved and more research is needed to detect its
reliability and clinical utility in limited-resource settings.

Keywords: COVID-19, Rapid Test, IgM/IgG, sensitivity, specificity, limited-resource