Move toward COVID-19 tests that can be performed outside of clinical laboratories may impact test volumes.
Additional funding by the US Department of Health and Human Services (HHS) toward SARS-CoV-2 point-of-care (POC) antigen testing is part of a growing trend that will affect clinical laboratories. COVID-19 diagnostic tests have almost exclusively required clinical laboratory-based testing. While the need for COVID-19 diagnostic testing has never been greater, the recent emergence of alternatives to lab-based SARS-CoV-2 PCR testing may indicate a long-term trend away from lab-based test methods.
3 Key Moves Changing the Landscape of Rapid POC Testing for COVID-19
- July 2, 2020: As previously published by the COVID-19 STAT Intelligence Briefings Service, an emergency use authorization (EUA) was granted to BD (Becton, Dickinson and Company) (See Antigen SARS-CoV-2 Diagnostic Test EUA Update).
- Twelve days later, HHS announced it would procure 2,000 of these POC test systems with 750,000 test kits for nursing homes across the country (See Nursing Homes: First Wave of Testing Begins as HHS’ Large Scale Distribution of SARS-CoV-2 POC Antigen Tests Takes Shape in Hotspots).
- Just over a week later, CMS announced weekly testing requirements for nursing homes in conjunction with a $5 billion funding initiative that included funding for 15,000 test kits (See HHS Directs $5 Billion for Nursing Homes to Perform Weekly Testing on Staff, But Clinical Laboratories are Unlikely to Benefit). The type of testing covered by the funds was not specified, but many inferred that nursing homes would follow the precedent of purchasing POC antigen test systems.
While POC SARS-CoV-2 antigen testing has been an emerging alternative to RT-PCR testing, the recent announcement by the US Food and Drug Administration (FDA) of an at-home and over-the-counter test development template also increases the likelihood that “non-lab setting” tests will soon become widely available.
In a new development in this area, BD announced July 30, that the US Department of Defense (DOD) in collaboration with HHS has provided $24 million to support the scale-up of US manufacturing capabilities for BD Veritor Solution for Rapid Detection of SARS-CoV-2.
According to a press release by BD, “The additional capital equipment will bolster domestic production and increase total production capacity by 50 percent. These investments will enable global production of more than 12 million test kits per month by the end of February 2021.”
Winners and Losers with Scaling Up Rapid POC Tests?
“Making COVID-19 diagnostic tests widely available is critical to expanding rapid detection of COVID-19 infections, and mitigating the impact of the disease by identifying affected patients, quickly quarantining infectious individuals and tracing their contacts,” said Dave Hickey, President of Integrated Diagnostic Solutions for BD. “This investment will bolster our U.S. manufacturing capabilities helping us quickly scale our production of point-of-care COVID-19 tests to ensure we have a robust supply for our U.S. customers.”
BD markets their SARS-CoV-2 antigen test system as ideal for use in clinician offices, urgent care centers, and retail pharmacies—entities that may be driving a meaningful portion of current COVID-19 PCR test volumes. The BD test is one of only two antigen tests that have been authorized by the FDA as of Aug. 13.
As new testing options become available, the trend of diagnostic tests moving outside of clinical laboratory settings may soon begin to impact the volume of these tests. Clinical laboratory leaders should consider the possibility that the high volumes of COVID-19 PCR tests may not last, and the need for them may soon be replaced with other testing modalities.
—By Caleb Williams, Editor, COVID-19 STAT