Laboratory diagnosis of SARS-CoV-2: available approaches and limitations

Abduljalil, Jameel M.

Abstract The ongoing pandemic of SARS-CoV-2 is a one of the most devastating outbreaks witnessed in the last 100 years. The outbreak started in China's hinterland and spread rapidly to almost every country culminating in woefully overwhelmed healthcare systems in most countries. The only approved diagnostic test to accompany radiographic evaluation is the reverse-transcriptase PCR. However, the applicability of this test in diagnosis and surveillance is challenged by global shortage in reagents and unavailability of well-equipped laboratories with specialized staff in several low- and middle-income countries. The need for development of accurate and rapid diagnostic assays became apparent. Handful of immunodiagnostic tests and other molecular approaches were developed and tested. Other recently developed point-of-care molecular tests are expected to be helpful in pandemic management since no particular skills are required from the operator. Fortunately, handful of serological tests have granted authorization to be used under emergency situation by FDA in diagnosis of SARS-CoV-2.