COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

Order for 3.5 Million POC SARS-CoV-2 Antigen Tests May Decrease Need for Clinical Lab-Based PCR Testing

Reopening schools during COVID-19

Consortium of seven states orders 3.5 million POC SARS-CoV-2 antigen tests.

A compact agreement by six states was announced with the purpose of securing COVID-19 testing supplies. In this consortium, the states committed to purchase 500,000 SARS-CoV-2 antigen tests each, with financing for this purchasing contract facilitated by The Rockefeller Foundation.

Maryland Gov. Larry Hogan, Louisiana Gov. John Bel Edwards, Massachusetts Gov. Charlie Baker, Michigan Gov. Gretchen Whitmer, Ohio Gov. Mike DeWine, and Virginia Gov. Ralph Northam announced the bipartisan compact Aug. 3, 2020. The governors encouraged other states to join them in the effort.

With Gov. Roy Cooper’s announcement, North Carolina became the seventh state to join a group purchasing agreement that could increase opportunities for more COVID-19 testing. (Photo source: Twitter)

North Carolina Gov. Roy Cooper announced the following day that North Carolina would join the purchasing compact, bringing the total number of states in the purchasing agreement up to seven and increasing the number of antigen tests being purchased to 3.5 million. North Carolina’s participation sets the precedent of adding states to the compact, and it remains to be seen how many other states will join.

States Form Purchasing Group for Rapid Antigen Tests and Supplies

“By banding together, the states are demonstrating to private manufacturers that there is significant demand to scale up the production of these tests, which deliver results in 15-20 minutes,” said Hogan in a statement. “With today’s agreement, the states are in discussions with Becton Dickinson and Quidel—the US manufacturers of antigen tests that have already been authorized by the FDA—to purchase 500,000 tests per state.”

It should be noted that since the agreement, the FDA has authorized a third antigen test as of Aug. 18—that of LumiraDx.

“Through this interstate compact, states are coming together to ramp up the use of rapid antigen testing to help better detect outbreaks more quickly and expand long-term testing in congregate settings such as schools, workplaces, and nursing homes,” said Hogan.

Substantial Federal Financial Support to Scale Up POC Antigen Tests

As previously published by the COVID-19 STAT Intelligence Briefings Service, recent trends in government funding and purchasing initiatives have heavily focused on POC antigen tests as a preferred method of SARS-CoV-2 diagnostic testing.

On July 14, 2020, HHS announced it would procure 2,000 of the BD Veritor Solution for Rapid Detection of SARS-CoV-2, BD’s antigen test systems, in addition to 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). Then 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). While the type of testing covered by the funds was not specified, many inferred that nursing homes would follow the precedent of purchasing POC antigen test systems. 

More recently, on July 30, HHS facilitated securing $24 million in funding for allowing BD to increase production of its antigen test. A press release by BD indicated that this increased funding would allow scaled production of the company’s antigen test systems by 50%.

Implications for Clinical Laboratories

Clinical laboratories have suffered severe and unexpected decreases in routine test volumes over the last two quarters due to the global pandemic. COVID-19 diagnostic testing has helped to offset these losses for many laboratories. However, the trend by government entities to push for POC antigen testing as a preferred testing method could lead to significant long-term effects as the demand for PCR-based testing decreases. 

Clinical laboratory administrators should be aware of these market influences and emphasize the increased reliability of PCR testing over antigen testing with existing partners who may be considering switching to POC antigen tests.

Caleb Williams

—By Caleb Williams, Editor, COVID-19 STAT

Related Resources:

The News & Observer: NC, 6 other states buying millions of coronavirus tests. Here’s how the tests are different

Governors of Maryland, Louisiana, Massachusetts, Michigan, Ohio, and Virginia Announce Major Bipartisan Interstate Compact For Three Million Rapid Antigen Tests

BD Announces $24 Million U.S. Government Investment to Support Scale Up of U.S. Manufacturing of COVID-19 Diagnostic Tests

LumiraDx UK Ltd. EUA Letter

Quidel EUA Letter

Becton Dickinson EUA Letter

The Rockefeller Foundation