Abbott COVID-19 test — used by White House — could be inaccurate, FDA warns.
found that the Abbott test returned false negatives for nearly 50 percent of certain samples that a rival test had found to be positive. The study has not been peer reviewed. In response, Abbott said that the results are not consistent with other studies and that the sample size was very small.The FDA now says patients with negative results from the Abbott test may need to be retested with a more sensitive test.
"This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test," Stenzel said. In a statement, the FDA said that it is sharing early information in"the spirit of transparency" and that it is working with Abbott. The company will send letters alerting users that any negative test results not consistent with a patient's clinical symptoms should be confirmed with another test.NBC News has asked Abbott for comment.
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