Abstract
In only a few months after initial discovery in Wuhan, China, SARS-CoV-2 and the associated coronavirus disease 2019 (COVID-19) have become a global pandemic causing significant mortality and morbidity and implementation of strict isolation measures. In the absence of vaccines and effective therapeutics, reliable serological testing must be a key element of public health policy to control further spread of the disease and gradually remove quarantine measures. Serological diagnostic tests are being increasingly used to provide a broader understanding of COVID-19 incidence and to assess immunity status in the population. However, there are discrepancies between claimed and actual performance data for serological diagnostic tests on the market. In this study, we conducted a review of independent studies evaluating the performance of SARS-CoV-2 serological tests. We found significant variability in the accuracy of marketed tests and highlight several lab-based and point-of-care rapid serological tests with high levels of performance. The findings of this review highlight the need for ongoing independent evaluations of commercialized COVID-19 diagnostic tests.
Highlights
Coronavirus disease 2019 (COVID-19) was first discovered in a cluster of patients with severe respiratory symptoms in Hubei Province, China, in December 2019
We conducted a systematic review of independent studies that assessed the performance of currently available SARS-CoV-2 serological tests
As serological tests are in high demand, in part due to an increase in large-scale seroprevalence studies, it is imperative for national and regional governments to continue coordinated efforts to independently validate serological test performance and partner with industry to scale up manufacturing and production capacity
Summary
Coronavirus disease 2019 (COVID-19) was first discovered in a cluster of patients with severe respiratory symptoms in Hubei Province, China, in December 2019. By early January 2020, analysis of bronchoalveolar lavage (BAL) fluid from infected patients revealed a pathogen, later named SARS-CoV-2, with 50%, 80%, and 96% genetic sequence overlap to the genome of the Middle East respiratory syndrome virus (MERS-CoV), the severe acute respiratory syndrome virus (SARS-CoV), and bat coronavirus RaTG13, respectively [1,2]. Drug Administration (FDA) Emergency Use Authorization (EUA) [5,6]. Under these circumstances, countries were forced to implement physical distancing measures to control the outbreak and, in the process, place approximately 3 billion people under lockdown.
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