Abbott ID NOW Controls (

ABBOTT PARK, Ill., Oct.7, 2020 / PRNewswire / – In an ongoing effort to provide the facts about ID NOW to support public health interests, Abbott (NYSE: ABT) is sharing new interim clinical data results on its ID NOW Rapid COVID-19 test.

The results confirm data submitted to the US Food and Drug Administration (FDA) in March for Emergency Use Authorization (USA) and interim results that Abbott shared in its May 21 press release. The data also speaks to the important role played by reliable point-of-care tests that are available in convenient and accessible places where people can get immediate results.

“We recognize that there is a lot of discussion about testing and identification NOW, and we want to make sure the public has the facts and data from the real world,” said Robert B. Ford, Abbott president, and CEO. “The data that we are seeing in one of the largest clinical studies of any COVID-19 test, conducted at some of the leading academic centers in the country, shows that ID NOW offers effective, consistent and reliable performance.”

“At the beginning of the pandemic, the scientific community had to rely on samples and models to predict test performance,” said John Hackett, Ph.D., divisional vice president of Applied Research and Technology for Abbott’s diagnostics business. “But we now have a significant set of real-world clinical data that supports the critical role ID NOW is playing in rapidly identifying infections where people present for care.”

“The tests are taken at a certain time and detect the virus once there is enough viral material in a person to be able to detect it,” continued Dr. Hackett. “While there is no perfect test, to combat a pandemic, we need a combination of standard laboratory PCR and rapid, accurate, and reliable tests like ID NOW to help reduce risk in society and slow the spread of the virus.”

Post-authorization study data

Abbott has completed an interim review of its ID NOW post-authorization study. A total of 1,003 people were evaluated in two care settings: urgent care clinics (acute care) and hospitals and nursing homes (hospital care). In these two care settings, ID NOW delivered the following agreement for laboratory-based molecular PCR testing:

Overall performance of 93.3% positive agreement (sensitivity) and 98.4% negative agreement (specificity). Furthermore, in the 161 patients with high viral titers (Ct <33) and therefore more likely to transmit the virus, ID NOW showed a 97.0% yield of positive agreement (sensitivity).

Performance of 95.0% positive agreement (sensitivity) and 97.9% negative agreement (specificity) in subjects within seven days of symptom onset. Furthermore, in the 129 patients with high viral titers (Ct <33) and, therefore, with a higher probability of transmitting the virus, ID NOW showed a yield of 98.4% positive agreement (sensitivity).

Performance of 94.6% positive agreement (sensitivity) and 97.6% negative agreement (specificity) in symptomatic subjects. In addition, in the 136 patients with high viral titers (Ct <33) and therefore more likely to transmit viruses, ID NOW showed a 97.8% positive agreement (sensitivity) performance. Provisional data updates from May 21 (previous studies) In addition to post-authorization data, Abbott is providing an update on three studies that were covered in its May 21 interim study press release:

Urgent care at various sites. In a comprehensive analysis of a multi-site urgent care clinical setting of 430 symptomatic patients with two or more symptoms, including 53 PCR-positive subjects, ID NOW demonstrated 96.2% performance in positive agreement (sensitivity) and 99.5% with the negative agreement (specificity) compared to laboratory-based molecular PCR tests.

Everett Clinic. In a comprehensive study at The Everett Clinic in Washington of 974 people, including 23 PCR-positive subjects, in association with Yuan-Po Tu, MD, ID NOW demonstrated 91.3% positive agreement (sensitivity) and 100% accuracy. negative agreement (specificity) compared to laboratory-based molecular PCR tests.

Internal patient. In a study of hospital care (hospitals and nursing homes), a total of 518 symptomatic patients were evaluated, including 94 subjects with positive CRP. ID NOW showed a 79,

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