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

The ongoing pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is one of the most devastating outbreaks witnessed in the last 100 years. The outbreak started in China and spread rapidly to almost every country, culminating in woefully overwhelmed health-care systems in most countries. The only approved diagnostic test to accompany radiographic evaluation is reverse transcription PCR. However, the applicability of this test in diagnosis and surveillance is challenged by a global shortage of reagents and the lack of well-equipped laboratories with specialized staff in several low- and middle-income countries. Loop-mediated isothermal amplification and CRISPR-based diagnostic assays have developed and expected to play a role however, their accuracy is still inferior to the recommended PCR approach. The need for the development of accurate and rapid diagnostic assays became apparent. 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 as no particular skills are required from the operator. Fortunately, a number of serological tests have been granted authorization for use under the emergency situation by the US FDA for the diagnosis of SARS-CoV-2. The majority of recently authorized serological tests detect IgG and IgM in blood of infected individuals by on ELISA, chemiluminescence platforms or lateral flow cassettes.