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Abbott’s Fast and Furious Pace with COVID-19-Related Tests Continues

TAGS: IVD
IMG_Oct122020at15859PM.jpg Sasa Kadrijevic -stock.adobe.com
The company was awarded emergency use authorization for the AdviseDx SARS-CoV-2 IgM serology test. This makes the seventh test Abbott has received EUA for since the pandemic began.

Abbott Laboratories isn’t showing any signs of slowing down when it comes down to rolling out new COVID-19-related diagnostics. The Abbott Park, IL-based company announced it had won emergency use authorization for the AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on the Architect and Alinity platforms. 

The impetus behind the test is to give a more complete picture of where patients are in the recovery process. Abbott said data about the AdviseDx serology diagnostic shows test results with 99.6% specificity and 95% sensitivity for patients tested 15 days after symptom onset

"Abbott has developed tests to detect the virus at each stage of infection so doctors and their patients are equipped with knowledge of how they are responding to the virus and progressing through recovery," said Robert Ford, president and CEO, Abbott. "Antibody tests will continue to play an important role to better understand the virus, the prevalence of COVID-19 in an area, and where a patient may be in their recovery."

Abbott has been granted emergency use authorization for seven tests since the beginning of the COVID-19 outbreak in the U.S. The number of diagnostic offerings for COVID-19 helped offset virus disruptions the company saw in its device businesses for Abbott’s 2Q20 earnings.

Abbott was one of the first companies to win EUA for a rapid COVID-19-related test. The company’s test was even highlighted during some of the White House Press briefings.

However, the firm caught some flak for the reliability of the tests.

In late August, Abbott made headlines when it won EUA for the BinaxNOW COVID-19 Ag card, a $5, $15-minute test to address the virus. In data submitted to FDA from a clinical study conducted by Abbott with several U.S. research universities, the BinaxNow test demonstrated sensitivity of 97.1% and specificity of 98.5% in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

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