![]() The FDA will continue to monitor data on the test and work with Abbott, which has agreed to conduct post-market studies on their rapid test. The FDA has received 15 "adverse event reports" about the test that indicate patients are receiving inaccurate results, according to the press release. The Abbott rapid test can still be used to identify positive COVID-19 cases, according to Stenzel, though negative results may need to go through a secondary process to be confirmed. "We will continue to study the data available and are working with the company to create additional mechanisms for studying the test." Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health. "We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," said Dr. ![]() It also cautions that "any negative test results that are not consistent with a patient's clinical signs and symptoms or necessary for patient management should be confirmed with another test." ![]() ![]() The FDA issued the alert on the Abbott test "in the spirit of transparency." In a press release, the agency said it's investigating whether the false-negative results could be connected to the type of swab used in the test or the material the samples are stored in for transport. Shots - Health News Study Raises Questions About False Negatives From Quick COVID-19 Test ![]()
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