Sensitivity and Specificity of Gold Chromatography Immuno-Assays IgM/IgG Antibody Test for COVID-19: Review of the current literature



Background: The World Health Organization recommends molecular tests (PCR) to the diagnosis of COVID-19, which detect the (SARS-CoV2) 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.

Methods: The literature search was conducted using PubMed, Google Scholar, Science Direct, supplemented by (Web of Science electronic databases), with the search term (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 control. The sensitivity and specificity of Gold Chromatography Immuno-Assays (GCIAs) IgM/IgG rapid test vary greatly among published studies. The IgM/IgG sensitivity ranged from 73.9 to 89.3% in 6/8 (75%) studies and the IgM/IgG specificity ranged from 88.9 to 100% in the eight (100%) reviewed studies. The pooled data revealed that the average of 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 symptomatic 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 in limited-resource settings. 

Keywords: COVID-19, Rapid Test, IgM/IgG, Sensitivity, Specificity, Limited-resource.

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