COVID-19 Antibody Tests News – The U.S. Food and Drug Administration (FDA) has recommended that clinical laboratories and health care providers stop using COVID-19 antibody tests listed on the FDA’s “removed” test list. On May 15, 2020, the FDA also issued a public alert regarding the accuracy of the Abbott ID NOW point-of-care test for diagnosing COVID-19.
COVID-19 Antibody Tests Information
On June 19, 2020, the FDA issued a letter to clinical labs and health care providers advising that certain COVID-19 antibody tests should not be used. The FDA’s “removed” test list should be used by providers as a guideline for what tests to avoid. This list includes tests where significant clinical performance problems were identified that cannot be, or have not been, addressed by the commercial manufacturer in a timely manner and tests for which an Emergency Use Authorization (EUA) request has not been submitted by a manufacturer of a serology test within a reasonable time period as outlined in FDA’s guidance.
Additional recommendations have been issued for providers and labs that still have these “removed” COVID-19 antibody tests in their inventory. Per the FDA’s announcement:
- Stop using the antibody tests listed on FDA’s “removed” test list.
- Evaluate, given the patient’s clinical presentation and medical history, whether prior test results generated using these tests may have been incorrect, and whether the patient should be retested using an FDA-authorized test.
- Remove from your stock any remaining tests that are listed on FDA’s “removed” test list.
- Report any issues with using COVID-19 tests to the FDA.
The FDA will continue to keep health care providers and the public informed of any new or additional information, as it becomes available.
Contact The Weinberg Law Firm for a Free Consumer Product Lawsuit Evaluation
If you or a loved one has been injured by a fraudulent, defective or recalled consumer product and have a question regarding your legal rights, please call The Weinberg Law Firm toll free at 877-934-6274, or submit our easy-to use Consumer Product Lawsuit Evaluation Form today.
To learn about our additional legal services please see Food Poisoning Lawyer, Medical Malpractice Lawsuit, Personal Injury Attorney, and Pharmaceutical Drug Litigation.
