The developer of the rapid response COVID-19 antigen test that gave Ohio Gov. Mike DeWine a false positive last week has a site located in Athens that is affiliated with a member of the Ohio University Board of Trustees.
Quidel Corporation is one of two companies in the country that’s developed a point-of-care antigen test authorized for emergency use by The Food and Drug Administration (FDA) to rapidly test patients for COVID-19. One of the company’s manufacturing, research and development sites is located at 2005 E. State St., near the yet-to-be-opened Menards.
It’s unclear if the Athens location had any part in the research, development or manufacturing of the company’s COVID-19 antigen test, which processes nasal swabs in a “$1,200 toaster-sized reader” called The Sofia 2 SARS Antigen FIA. The test, which has come under fire by some for its lack of accuracy relative to alternatives, can return results within 15 minutes. The company didn’t respond to The Athens NEWS’ multiple requests for comment.
OU Trustee Dave Scholl previously served as CEO of Diagnostic Hybrids, a start-up that merged with Quidel in 2010, leading to the creation of the Athens location, according to a previous report in The NEWS. Scholl served as senior vice president of Quidel until 2011 when he retired.
Last week DeWine received a false positive for the virus through a Quidel antigen test that was administered as part of standard protocol before he was scheduled to greet President Donald Trump at a Cleveland airport.
DeWine, his wife Fran and his staff all tested negative later that day through a PCR test that’s known for being far more sensitive and reliable than antigen tests. Subsequent PCR tests also rendered negative results for the governor and his staff.
DeWine vowed earlier last week to purchase 500,000 rapid response Quidel antigen tests through a cooperation with the governors of Maryland, Louisiana, Massachusetts, Michigan, and Virginia to help increase testing across the country, according to a news release.
“Time is of the essence, which is why I am pleased to join with my fellow governors to work together to expand the use of rapid, point-of-care antigen tests in order to help to slow the spread of COVID-19 in our states,” DeWine said at the time.
But after his experience receiving faulty results, DeWine said his administration will have to “think long and hard” about how to proceed with antigen tests.
Quidel’s test can generate false negative results up to 20 percent of the time, company executives told Science Magazine in May. Though it’s unclear how often Quidel’s device produces false positives.
It’s also unclear whether Trump or other White House staffers regularly use Quidel’s antigen test as part of the standard protocol DeWine underwent. The White House did not respond to The NEWS’ request for comment on the matter.
The New York Times reported in May, however, that The White House used Abbott Laboratories’ point-of-care ID Now testing device at the time, which is different from an antigen test. It was authorized for emergency use by the FDA in late March.
Though, the FDA issued a statement in May alerting the public of the possibility of the point-of-care ID Now test to render inaccurate results.
A study conducted at New York University found that The ID Now missed nearly 50 percent of positive cases using dry nasal swabs. Abbott Laboratories in a statement provided to The New York Times denied the consistency of that study’s findings relative to other research of the test.
OhioHealth also uses the point-of-care ID Now test for rapid results in certain cases, but not Quidel’s antigen test, Director of Media Relations Mark Hopkins said in an email.
“We don’t currently use the antigen test because we are satisfied with, and confident in, the PCR based tests, and molecular point-of-care assays that we use,” Hopkins stated.
Holzer Health Systems also doesn't use antigen testing and instead relies solely on PCR tests, a public information officer said in a statement. The vast majority of testing done in Athens is through the much more reliable PCR tests.
Maggie Haberman, a New York Times White House correspondent, said in a tweet after news broke of DeWine receiving faulty results that false positives aren’t uncommon in The White House.
“The test the White House has been using has a high false rate; there have been staff members who tested positive who tested negative a short time later. And there have been questionable negatives,” she wrote.
Becton Dickinson & Company (BD) is the only other firm to have its rapid results antigen test authorized by the FDA for emergency use. That test reports false negative results about 15 percent of the time, according to a company news release.