This assay has the potential to track COVID-19 antibody responses but this paper does not present evidence about its efficacy as an early diagnostic tool or its possible success with a variety of genotypes. Therefore, this may have a limited degree of success in detecting infected individuals. This method of rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis needs further validation.
Real time RT-PCR for SARS CoV-2 remains the mainstay of diagnosis at present. Till date, 23 antibody based (IgM, IgG) rapid tests have been validated at NIV, Pune. ICMR guidance on rapid antibody kits state that the rapid assays are not recommended for diagnosis of COVID-19 infection (dated 16.04.2020). WHO too does not recommend the use of antibody based rapid diagnostic test for patient care, based on current evidence.
Li Z, Yi Y, Luo W, et al. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol. 2020 Feb 27. doi: 10.1002/jmv.25727.Indications and tests-Rapid antibody kits