FDA Authorizes First At-Home COVID-19 Antigen Tests, but Roadblocks Remain for “Fast-and-Frequent” Antigen Testing

Developers of medical laboratory tests had high hopes that cheap saliva-based tests would compete with at-home OTC tests that use nasal swabs, but skepticism among scientists continues Reverse-transcription polymerase chain reaction (RT-PCR) technology has become the standard for clinical laboratory diagnostic testing used to detect the presence of the SARS-CoV-2 coronavirus. However, to enable more widespread testing, some public health experts have called for deployment of cheap, rapid,...

US Government Purchases 150 Million COVID-19 Antigen Tests from Abbott Laboratories for $760 Million; Only CLIA-Certified Clinical Laboratories Can Do Testing

Abbott sends the SARS-CoV-2 test results directly to patients’ smartphones, which can be displayed to gain entrance into areas requiring proof of COVID-19 testing There is no greater example that COVID-19 is a major force for change in the clinical laboratory industry than the fact that—though the US federal government pays 50% of the nation’s total annual healthcare spend of $3.5 trillion—it recently spent $760 million to purchase 150 million COVID-19 tests from Abbott Laboratories...

US Works with Clinical Laboratories to Launch Several Large-Scale COVID-19 Serological Surveys to Track Undetected COVID-19 in the Nation’s Population

Though some experts claim widespread antibody testing is key to effective public health safety, the WHO warns positive serological tests may not indicate immunity from reinfection or transmission of SARS-CoV-2 It may be the largest program of clinical laboratory testing ever conducted in the United States. Health officials are preparing to undertake large-scale serological surveys (serosurveys) to detect and track previously undetected cases of SARS-CoV-2, the novel coronavirus, that causes...
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