Abstract
BackgroundCoronavirus 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).ObjectiveWe 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.MethodsUsing 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’.ResultsA 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).ConclusionWe 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.
Highlights
Coronavirus disease 2019 (COVID-19) is an emerging respiratory disease that was first reported to the World Health Organization (WHO) as a cluster of pneumonia of unknown origin from Wuhan, China, in December 2019.1 The unknown causative agent was found through deep sequencing to be severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) on 7 January 2020 and the disease COVID-19 was named on 11 February 2020
Earlier cases of COVID-19 in many low- and middle-income countries (LMICs) were described as imported by travelers from China, Italy, the United Kingdom and Germany, community transmission has become the major cause of new COVID-19 infections.[3,4]
The availability of the SARS-CoV-2 genome has led to the development and validation of various reverse transcriptase real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test kits by different manufacturers for COVID-19 diagnosis.[5,6]
Summary
Coronavirus disease 2019 (COVID-19) is an emerging respiratory disease that was first reported to the World Health Organization (WHO) as a cluster of pneumonia of unknown origin from Wuhan, China, in December 2019.1 The unknown causative agent was found through deep sequencing to be severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) on 7 January 2020 and the disease COVID-19 was named on 11 February 2020. WHO declared COVID-19 as a Public Health Emergency of International Concern on 30 January 2020 and a pandemic on 11 March 2020.1 As of 22 April 2020, an estimated 2 572 805 confirmed cases and 178 551 confirmed deaths from COVID-19 had been reported.[2] The first 10 cases in Africa were reported in five countries (Nigeria, Algeria, Morocco, Egypt and Senegal).[3] earlier cases of COVID-19 in many low- and middle-income countries (LMICs) were described as imported by travelers from China, Italy, the United Kingdom and Germany, community transmission has become the major cause of new COVID-19 infections.[3,4] Early, rapid, largescale diagnosis and accurate diagnosis of COVID-19 is one of the key interventions for COVID-19 containment in both high-income and LMIC settings.[3] The availability of the SARS-CoV-2 genome has led to the development and validation of various reverse transcriptase real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test kits by different manufacturers for COVID-19 diagnosis.[5,6] This diagnostic test is based on the detection of genes encoding the envelope (E), spike (S), nucleoplasid (N), RNA-dependent RNA polymerase and open reading frame 1a/b (e.g. Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has impacted heavily on global health. 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)
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