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?:abstract
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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 resourcescarce 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
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