Role of clinical laboratories in response to the COVID-19 pandemic

Document Type



Pathology (East Africa)


The outbreak of COVID-19 (caused by SARS-CoV-2) is now a pandemic that has caused a global socio-economic disorder. Since its identification in the region of Wuhan, China, 2,629,579 confirmed cases with over 182,900 COVID-19-related deaths have been reported globally [1]. In response to the outbreak, several state authorities and commercial companies have developed diagnostic assays to test individuals for the SARS-CoV-2 infection. Currently, over 40 diagnostic assays have received Emergency Use Authorization (EUA) from the Federal US FDA for COVID-19 testing. In the US, clinical laboratories are required to perform ‘bridging studies’ on FDA-approved SARS-CoV-2 diagnostic assays to implement testing under the EUA regulation.

Absence of adequate testing due to various factors, most significant of which being supply chain issues, is most likely contributing to community spread. In midst of numerous challenges, clinical laboratories have a critical role to play in response to the current COVID-19 pandemic. In addition to ensuring the testing requirements of the population in the present hour, laboratories have an unprecedented responsibility to prepare for the aftermath of the pandemic. Although, the reverse transcription-polymerase chain reaction (RT-PCR)-based assays for the detection of SARS-CoV-2 nucleic acid regions might be the most practical approach at present, qualitative assays are far from providing insights into the evolution of the virus and the varied immune response in different populations. Herein, we discuss the three main categories of diagnostic assays available for the identification of SARS-CoV-2 infection, their utility and a way-around the challenges associated with each assay. Further, laboratory management issues are highlighted that might be considered by laboratories for optimal functioning.

Publication (Name of Journal)

Future Medicinal Chemistry