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Study suggests test used in RI may miss many coronavirus cases

Coronavirus

PROVIDENCE, R.I. (WPRI) — A new study out of New York University is raising doubts about the reliability of the rapid testing system Rhode Island has been relying on for a significant portion of its coronavirus testing, though the findings have not yet gone through the academic peer review process.

The ID NOW test by Abbott Laboratories is being used by CVS Health at the rapid-testing site the Woonsocket-based company set up in the Twin River parking lot in Lincoln. That site’s launch in early April has been widely credited with moving Rhode Island from laggard to leader in per-capita tests compared with other states.

The new study — posted on BioRxiv, a clearing house for research awaiting review by other scientists — found that the Abbott ID NOW system missed one out of every three positive samples discovered by a slower test developed by Cepheid Inc., and it missed almost half the positive samples found by using a dry nasal swab.

CVS referred questions about the test to Abbott, whose spokesperson, John Koval, said the NYU findings “are not consistent with other studies” and that Abbott has “many questions for the study authors.”

“While no test is perfect, Abbott’s ID NOW is delivering reliable results when and where they’re needed most,” Koval said. “The test is performing as expected by the more than 1,000 sites using ID NOW for COVID-19.”

“The world needs a variety of tests in labs and at point of care, and as many as possible, if we are to help reduce the risk people have every single day of contracting the virus,” he added. “ID NOW is an important tool in that equation.”

It’s not the first time doubts have been raised about the reliability of the Abbott test. Last month, the Cleveland Clinic stopped using the test after researchers there found a double-digit rate of false negatives. At the time, a spokesperson for the company downplayed the results, suggesting that the test performs well when done properly.

During Wednesday’s daily coronavirus briefing, Health Department Director Dr. Nicole Alexander-Scott said a testing and validation task force convened by the state is examining the reliability of the Abbott system as part of its work. She reiterated that the tests work best on people with symptoms.

“These studies help reinforce that, particularly if you have people without symptoms who are getting tested,” she said. “Regardless of the type of test, if someone has symptoms and has a negative result, we are saying still stay home if you’re ill — continue to do the same kind of isolation that would be required whether it’s the flu or COVID-19 or a cold.”

In a follow-up email, Health Department spokesperson Joseph Wendelken said, “A small number of people in the hospital in Rhode Island (roughly five) have had negative PCR tests (non-Abbott), and then positive antibody tests. And we have had people who have had clinical presentations and contact histories that would strongly lead someone to believe that they were COVID positive, but then they had negative Abbott tests.”

“This could be the result of the way that the specimen was collected” Wendelken continued, noting that people self-swab for the Abbott test. “This is hard to quantify, because it’s not a black-and-white situation. But it’s a smaller number.”

Ted Nesi (tnesi@wpri.com) is WPRI 12’s politics and business editor and a Target 12 investigative reporter. He is a weekly panelist on Newsmakers and hosts Executive Suite. Follow him on Twitter and Facebook

Kim Kalunian contributed to this report.

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