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Walk-up coronavirus screening site opens in Baltimore, using test equipment under FDA investigation

A rapid testing site that aims to confirm coronavirus infections in 30 minutes or less has opened at Baltimore’s Mondawmin Mall, state and private officials said Friday.

Health care providers from MinuteClinic, the division of CVS Health that administers medical services, will staff the testing site, operated in the parking lot of the Target store that closed in 2018. The tests are free of charge but must be scheduled in advance by people who meet certain conditions based on a qualifying “quiz.”

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The site offers another testing location for the COVID-19 illness caused by the virus for hard-hit West Baltimore and its vulnerable residents. Unlike drive-through testing sites at Pimlico Race Course and in Druid Hill Park, Mondawmin Mall is a transit hub, served by buses and the Metro SubwayLink, so it’s more accessible to residents who don’t own cars.

But doubts have been raised about the accuracy of the testing equipment CVS is using at the site — the Abbott ID NOW system.

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The U.S. Food and Drug Administration said last month it is investigating reports of false negative results by the system in which people were told they were not infected with the coronavirus when they actually were.

The agency has received 109 reports of such “adverse events,” though a spokeswoman said those reports “can be incomplete, inaccurate, or unverified” and need to be vetted to determine any issues of concern.

Scientists at New York University published research soon after that, finding that between a third and 45% of samples that tested positive with a different rapid-testing system came back negative when using the Abbott system.

There are also concerns of possible coronavirus exposure to staff conducting the tests. Splatter and aerosols can escape from the testing equipment, potentially spreading the virus. The Association of Public Health Laboratories recommends using the test kits inside lab containment equipment known as biosafety cabinets.

Garth Graham, vice president of community health for CVS Health, said the company has been using the Abbott system according to proper protocols at nine other community testing sites around the country without issue. And the rate of positive tests at the five largest of those sites has been higher than in the community around them, suggesting there is no problem with false negatives, he said.

“The FDA has said the test can continue to be used while they study the claims,” Graham said.

Abbott representatives said other studies have shown the ID NOW system’s accuracy to be nearly as high as more widespread PCR-based coronavirus testing systems, with Abbott’s system confirming as much as 94.7% of positive tests found with those systems.

And Abbott officials said the ID NOW testing system has been used safely since 2014 for detection of the seasonal flu, but acknowledged some additional training may be needed in some cases to ensure the test kits are used safely.

“Because of the COVID-19 pandemic, ID NOW is being used by people for the first time who may not be familiar with standard point-of-care testing protocols,” they said in a statement. “We’re working to educate and train them on the use of ID NOW so they are as confident in ID NOW as our customers who have used it for years.”

Maryland Gov. Larry Hogan and his administration touted the new site as another example of the state’s commitment to providing wide access to testing. Hogan spokesman Mike Ricci said state health officials “fully reviewed” CVS’s testing protocols before clearing the site to open.

“Whether you are part of a vulnerable population, are beginning to return to work, or have recently taken part in a large gathering, testing is becoming even more critical than ever,” the Republican governor said.

Testing at the site is conducted inside a tent. Results will be provided on the spot, but only about the person’s likelihood of having the coronavirus. Even those who test negative for the coronavirus still could test positive for COVID-19. Those results will take two to four days to get back.

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The testing is being paid for by the federal government under a contract with CVS, Graham said.

CVS Health operates several dozen testing sites around Maryland.

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