The success of treatment, quarantine and, ultimately, return to normalcy, all hinge on the development and dissemination of tests capable of not just accurate but rapid detection of COVID-19 coronavirus. Among the most promising solutions are point-of-care (POC) molecular-based immunodiagnostic tests that detect SARS-CoV-2 antibodies. On March 21, the Cepheid Xpert Xpress SARS-CoV-2 test became the first POC COVID-19 detection assay to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration. More POC test approvals followed in rapid order, including assays from Abbott, Mesa Biotech and the combination of Becton Dickinson and BioGX. And dozens more are in the pipeline and likely to gain EUA in the coming months, if not weeks. Hip-hip-hooray! Right? Well, maybe not so much, at least to some critics. The cloud to the silver lining is that POC COVID-19 antibody testing is unproven. So, even as the FDA admits them into the US market, the World Health Organization (WHO) says they shouldn’t be used for clinical decision making. The Diagnostic Challenge Most of the current COVID-19 tests, including the US Centers for Disease Control and Prevention (CDC) that received the initial EUA from the FDA, are based on reverse transcriptase polymerase chain […]