Wartime law set to increase production volumes of POC COVID-19 tests.
On Aug. 20, 2020, the US Department of Health and Human Services (HHS) announced it would invoke the Defense Production Act (DPA) to apply priority-rated orders for SARS-CoV-2 antigen testing contracts. The contracts that are receiving prioritization are with Becton Dickinson (BD) and Quidel Corporation—the two established manufacturers of diagnostic SARS-CoV-2 antigen tests. A third rapid antigen test by LumiraDx had received an emergency use authorization (EUA) two days before the HHS announcement.
According to the HHS statement, “These acquisitions will fulfill a large-volume purchase of diagnostic systems and assays for COVID-19 testing and will expedite shipments of these systems and assays to every nursing home certified by the Centers for Medicare and Medicaid Services (CMS) with a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver—approximately 14,000 nursing homes—in the United States.”
Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, MD, issued a statement regarding this announcement. “The federal efforts to supply nursing homes with rapid point-of-care antigen instruments and tests is our highest priority to save lives and the US Government will exert its full authority to complete this mission,” Giroir said in the announcement. “We are invoking the priority rating of the Defense Production Act to expedite shipments of instruments and antigen tests to give nursing homes the ability to perform these rapid tests. HHS will continue to explore every possible avenue to get life-saving supplies to the frontlines of this war on the virus.”