Standardization and validation of a point-of-care RT-qPCR test in response to the COVID-19 pandemic
The novel coronavirus (SARS-CoV-2) is the etiological agent of the ongoing COVID-19 pandemic currently affecting 215 countries and territories. With the number of cases increasing exponentially in many nations, molecular diagnostics have become a critical component for informing decisions related to health. However, the availability of molecular diagnostics has suffered a bottleneck. Reverse transcription-quantitative polymerase chain reaction (RT-qPCR), the standard method for molecular detection of the virus requires rigorous standardization and validation to avoid a high false-negative rate (FNR). An elevated FNR would constitute an unacceptable obstruction to virus detection and monitoring. Although different kits have been developed, most of them lack the portability required. In consequence, a portable point-of-care (POC) test would be highly beneficial to help reduce the spread of the virus and ultimately, save lives. The objective of our proposal is to support the development, standardization and validation of a portable RT-qPCR kit for onsite diagnosis of SARS-CoV-2.