COVID-19 rapid diagnostic test could contain transmission in low- and middle-income countries.

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has impacted heavily on global health. Although real-time polymerase chain reaction (RT-PCR) is the current diagnostic method, challenges for low- and middle-income countries (LMICs) necessitate cheaper, higher-throughput, reliable rapid diagnostic tests (RDTs). OBJECTIVE: We reviewed the documented performance characteristics of available COVID-19 RDTs to understand their public health utility in the ongoing pandemic, especially in resource-scarce LMIC settings. METHODS: Using a scoping review methodology framework, common literature databases and documentary reports were searched up to 22 April 2020, irrespective of geographical location. The search terms included 'SARS-CoV-2 AND serological testing' and 'COVID-19 AND serological testing'. RESULTS: A total of 18 RDTs produced in eight countries, namely China (6; 33.33%), the United States (4; 22.22%), Germany (2; 11.11%), Singapore (2; 11.11%), Canada, Kenya, Korea and Belgium (1 each; 5.56%), were evaluated. Reported sensitivity ranged from 18.4% to 100% (average = 84.7%), whereas specificity ranged from 90.6% to 100% (average = 95.6%). The testing time ranged from 2 min to 30 min. Of the 12 validated RDTs, the IgM/IgG duo kit with non-colloidal gold labelling system was reported to elicit the highest sensitivity (98% - 100%) and specificity (98% - 99% for IgG and 96% - 99% for IgM). CONCLUSION: We found reports of high sensitivity and specificity among the developed RDTs that could complement RT-PCR for the detection of SARS-CoV-2 antibodies, especially for screening in LMICs. However, it is necessary to validate these kits locally.