SPECIAL REPORT: Primary Testing Machine Used in RI “Missed 48%” of Cases, According to Study

SPECIAL REPORT: Primary Testing Machine Used in RI “Missed 48%” of Cases, According to Study

The majority of Rhode Island’s coronavirus tests have been conducted at the Twin River facility using a testing machine produced by Abbott, but the equipment being used may be seriously flawed, according to a new study.

That testing facility is run by CVS and Rhode Island Governor Gina Raimondo has trumpeted the success of the program, lauding the partnership on national interviews on CNBC and CNN.

For the first 5 weeks of the coronavirus crisis, Rhode Island only averaged 178 tests per day. The CVS program allowed testing to be dramatically increased. Now, the state claims 101,601 people have been tested through Wednesday.

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The Abbott machine is also used at the White House.

Testing in Question

A new study by lab officials at NYU Langone Health released this week found the Abbott test device missed 48% of 31 positive cases when using dry swabs.

On April 6, after the CVS testing facility was announced, GoLocal asked the company about the effectiveness of the Abbott device.

“Abbott’s ID NOW COVID-19 test is what is being used at the Lincoln testing site at Twin River. I don’t want to speak for Abbott, so they would be the best resource for any comment on the specifics of their test,” said Mike DeAngelis, Senior Director, Corporate Communications in an email to GoLocal.

Abbott did not respond to questions from GoLocal about the efficacy of the testing device.

On Friday, the Wall Street Journal reports that Abbott was changing the protocol for the test with new directions.

“Abbott Laboratories said Thursday that it would change the instructions for using its fast coronavirus test for a second time, days after a preliminary study by a major medical center found the device frequently gave negative results for patients who were infected with the virus. The change will tell users that negative results produced by Abbott’s ID Now device are ‘presumptive’ and should be verified with an alternative test for patients with signs of the virus. That means sacrificing the device’s quick turnaround time for some patients as tests are repeated using methods that can take much longer,” reports the Wall Street Journal.

According to the WSJ, "[The] Food and Drug Administration said it had received 15 adverse-event reports concerning the device 'that suggest some users are receiving inaccurate negative results.' The agency said it would review data Abbott had agreed to collect through follow-up studies that will include at least 150 patients tested with the device. 'Negative results may need to be confirmed with a high-sensitivity authorized molecular test,' said Tim Stenzel, the director of the FDA’s diagnostics arm, in a statement."

Abbott issued a statement on Thursday in response to the new study:

We're seeing studies being conducted to understand the role of ID NOW in ways that it was not designed to be used. In particular, the NYU study results are not consistent with other studies. While we've seen a few studies with sensitivity performance percentages in the 80s, we've also seen other studies with sensitivity at or above 90%, and one as high as 94%.

While we understand no test is perfect, test outcomes depend on a number of factors including patient selection, specimen type, collection, handling, storage, transport and conformity to the way the test was designed to be run. ID NOW is intended to be used near the patient with a direct swab test method.

It is our responsibility to provide healthcare professionals and the public with accurate information, and that's why we're doing the following:

Further clarifying our product information to provide better guidance to healthcare providers that negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Negative results should be presumed negative, but if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative molecular assay.

We are also reinforcing proper sample collection and handling instructions. We are communicating this to our customers.

Continuing to optimize this test as the world learns more about this virus. We're working to incorporate those learnings into the test as we do with all of our diagnostics tests.