![]() ![]() Due to that, mass testing has been central to the worldwide disease containment efforts which represented a challenge to cost, scalability, and speed of state-of-the-art viral screening technology. The problem is exacerbated by the presence of many asymptomatic patients that can only be identified via molecular based disease screening methods. In the absence of proven antiviral drug therapies and commercially available vaccines, the current pandemic containment and mitigation strategy is relying on the isolation of the infected individuals and their close contacts in addition to social distancing. To date, only a very limited number of therapeutic options have shown little effects on reducing COVID-19 associated death, such as remdesivir and dexamethasone (reviewed in Kaddoura et al., 2020). The clinical manifestations of COVID-19 include fever, cough, fatigue, and breathing difficulties, which could result in severe complications, such as severe pneumonia and respiratory distress syndrome (ARDS). On the other hand, its incubation period from infection to first symptoms is on average 5 days with a possibility of reaching 14 days ( Wu et al., 2020b). Its reproduction number (R 0) is estimated to be around 2.68 with a doubling time of 6.4 days. SARS-CoV-2 is highly contagious and spreads from person-to-person by the respiratory route, primarily via droplets, aerosols, and contact with contaminated surfaces and fomites ( Yeasmin et al., 2020). The disease has since spread across the globe infecting over 215 countries. ![]() Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) leads to the infectious disease COVID-19, which was first reported in Wuhan, China in December 2019. In this review, we aim to carefully examine commercialized and FDA approved molecular-based and serology-based diagnostic assays, analyze their performance characteristics and shed the light on their utility and limitations in dealing with the COVID-19 global public health crisis. ![]() Given the differences in assasy format and/or design as well as the lack of rigorous verification studies, the performance and accuracy of these testing modalities remain unclear. More than 140 diagnostic assays have been developed as of this date and have received the Food and Drug Administration (FDA) emergency use authorization (EUA). Unlike molecular testing, immunoassays are indirect testing of the viral infection. Molecular assays have been the gold standard for direct detection of the presence of the viral RNA in suspected individuals, while immunoassays have been used in the surveillance of individuals by detecting antibodies against SARS-CoV-2. The highly contagious nature of this respiratory disease challenges advanced viral diagnostic technologies for rapid, scalable, affordable, and high accuracy testing. The world continues to grapple with the devastating effects of the current COVID-19 pandemic. ![]()
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