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Abbott ID Now Study Data Confirms Test Sensitivity and Specificity

NEW YORK – Abbott Laboratories released data from an interim clinical study on Wednesday that confirmed the sensitivity and specificity of its ID Now COVID-19 rapid test.

The study tested 1,003 people in urgent care clinics and hospitals and nursing homes and found 95 percent sensitivity and almost 98 percent specificity within a week of symptom onset, the company said in a statement. These results confirm the data Abbott submitted to the US Food and Drug Administration for the test's Emergency Use Authorization.

Overall, performance found 93 percent sensitivity and 98 percent specificity in all patients, with 97 percent sensitivity in patients with high viral titers. For symptomatic patients, sensitivity was nearly 95 percent and specificity nearly 98 percent. 

In May, a study published in BioRxiv found the point-of-care test missed as much as almost half of the positive cases detected by Cepheid's Xpert Xpress SARS-CoV-2 test. According to the New York University study, which had not been peer-reviewed, as the viral load decreased, Abbott's test produced more false negatives.

"In the beginning of the pandemic, the scientific community had to rely on samples and modeling to predict test performance," John Hackett, the divisional VP of Applied Research and Technology for Abbott's diagnostics business, said in a statement on Wednesday. "But now we have a significant body of real-world, clinical data that support the critical role ID NOW is playing in identifying infection rapidly in places where people show up for care."

Abbott's ID Now, as well as the firm's BinaxNow rapid antigen test, have reportedly been used to test members of the White House staff, many of whom have tested positive recently, including President Donald Trump. The company said it has shipped more than 12 million ID Now tests to date in the US, and more than 30 million total COVID-19 tests since March.

Abbott also released updates for three studies it had previously mentioned in May. In an analysis of symptomatic patients at a multisite urgent care setting, sensitivity was 96 percent and specificity was nearly 100 percent compared to lab-based molecular PCR tests. A study at the Everett Clinic found 91 percent sensitivity and 100 percent specificity, and an inpatient study of symptomatic patients at hospitals and nursing homes found 80 percent sensitivity and 94 percent specificity.

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