ORALS

There have been tremendous advances in in vitro diagnostic (IVD)(1) assays and smart technologies for the diagnosis, monitoring and management of coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main IVD formats used for pandemic response of COVID-19 are real-time reverse transcriptase polymerase chain reaction (RT-PCR) and rapid viral antigen detection tests. Most rapid RT-PCR tests, such as those from Cepheid and Bosch, take about 40 min, while most rapid lateral flow immunoassay (LFIA) tests for viral antigen detection take less than 20 min. An exciting development has been the point-of-care (POC) molecular test (ID NOWTM)(2) and rapid antigen test (BinaxNOWTM COVID-19 Ag card)(3) by Abbott, which take just 5 min and 15 min, respectively. A large number of molecular & rapid antigen tests have been approved by the United States Food and Drug Administration (FDA) under emergency use authorization (EUA)(4) and are already Conformité Européenne (CE) certified. Similarly, many serology immunoassays (IAs) have also been developed for the detection of anti-SARS-CoV-2 antibodies (i.e., immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA)) produced in humans in response to SARS-CoV-2 infection. The most prominent serology IAs are automated chemiluminescent IA (CLIA), ELISA, and rapid LFIA. However, there is still an imminent need for novel POC fully-integrated IVD test that can detect multiple biomarkers involved in the early manifestation of COVID-19 using a smart readout device. Of interest will be an IVD technology enabling molecular, antigen, and antibody detection in a single platform. Various smart applications have been developed worldwide for contact tracing, which have been very useful to control the spread of COVID-19. Artificial intelligence and machine-learning have further facilitated the rapid and efficient diagnosis of COVID-19 infections. Telemedicine and digital healthcare have played a phenomenal role during the current pandemic, which has unleashed their high utility for future pandemics. The future directions in IVD, mobile healthcare and smart technologies, paving way to better health outcomes and effective pandemic response, will be presented.

References:
1. Vashist SK. In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends. Diagnostics (Basel). 2020;10(4):202.
2. ID NOW™ Covid-19. https://www.alere.com/en/home/product-details/id-now-covid-19.html. 2020.
3. Perchetti GA, Huang M-L, Mills MG, Jerome KR, Greninger AL. Analytical Sensitivity of the Abbott BinaxNOW COVID-19 Ag CARD. Journal of Clinical Microbiology. 2021;59(3).
4. In Vitro Diagnostics EUAs, 2021 [Available from: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas#umbrella-serological.