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Lab technicians will immerse the sample on April 10, 2020 in the Abbott Laboratories ID Now tester at the Detroit Health Center.

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Carlos Osorio / AP

Lab technicians will immerse the sample on April 10, 2020 in the Abbott Laboratories ID Now tester at the Detroit Health Center.

Carlos Osorio / AP

Updated at 11:16 pm. ET

The Food and Drug Administration warns the public about the reliability of rapid tests for widely used coronaviruses. The tests performed by Abbott Laboratories are associated with inaccurate results that can falsely reassure patients that they are not infected with the virus.

The Trump administration promotes testing as an important factor in controlling the epidemic in the United States and is used in the daily tests conducted at the White House.

So First reported in NPRFor every 100 tests, 15 to 20 tests can falsely produce negative results. Subsequent studies published this week have shown that this test may miss 48% of infections.

The FDA has issued a warning “in the spirit of transparency” about the Abbott test, and in a press release whether false-negative results are related to the type of swab used during the rapid test, or when material samples are in transit. It will be stored.

It also warns, “Any test that does not match the patient’s clinical signs or symptoms, or that is negative for the patient’s management, needs to be confirmed by another test.”

“We are still evaluating information about inaccurate results and are in direct contact with Abbott on this important issue,” said Tim Stenzel, director of the FDA’s Department of In-Vitro Diagnostics and Radiology. .. “We continue to study the available data and work with companies to create additional mechanisms for studying tests.”

According to Stenzel, COVID-19-positive cases can be identified using the Abbott Rapid Test, but if they are negative, they may need to go through a secondary process for confirmation.

According to the press release, FDA has received 15 “Adverse Event Reports” on tests that show patients receiving inaccurate results.

FDA will work with Abbott, who has agreed to continue to monitor data on testing and conduct post-marketing surveillance for rapid testing. According to the FDA’s announcement, this study will include a minimum of 150 people who were previously diagnosed as positive for coronavirus and conducted in the clinical setting.

Abbott’s stock price fell more than 3% during Thursday’s after-hours trading.

Company Told NPR In late April, the test issue may be due to the samples being stored in a special solution called virus transport medium before the test, rather than being inserted directly into the company’s test machine. As a result, the company recently instructed users to avoid using this solution and place samples directly in the machine for testing.

In addition, Abbott continued to defend the accuracy of the tests and pointed out other studies that proved to be as accurate as the other tests used.

Accurate and timely testing is a major challenge in coronavirus pandemics. In addition to the issue of rapid test accuracy, there are also issues of certification. Antibody test – Something that can detect if someone has been infected with COVID-19 in the past.

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