September 17, 2021
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of a potential for false-positive results with the Alinity m SARS-CoV-2 AMP Kit, List Number 09N78-095, and Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096. The false-positive results may be related to current mixing parameters of the PCR reaction mixture that may result in potential overflow that could carry over into neighboring wells in the assay reagent tray. Overflow into the wells of true negative samples that are positioned near positive samples in the assay tray could produce false-positive results.
Recommendations
The FDA recommends that clinical laboratory staff and health care providers:
- Consider any positive result from tests using the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP Kits to be presumptive. Consider retesting positive patient specimens performed in the last two weeks with an alternate authorized test.
- Consider communicating to patients who received positive results using the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP Kits, starting in June 2021, that they may have had a false positive test result.
- Report any issues with using COVID-19 tests to the FDA. See Reporting Problems to the FDA below.
Background
The FDA issued an Emergency Use Authorization (EUA) to permit emergency use of the Alinity m SARS-CoV-2 AMP test on May 11, 2020 and granted revisions to the EUA with the most recent revision granted in August 2021. The Alinity m SARS-CoV-2 AMP Kit is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity tests.
The FDA issued an Emergency Use Authorization (EUA) to permit emergency use of the Alinity m Resp-4-Plex AMP test on March 4, 2021. The Alinity m Resp-4-Plex AMP Kit is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity tests.
FDA Actions
The FDA is working with Abbott Molecular Inc. to resolve these issues. The FDA will continue to keep clinical laboratory staff, health care providers, and the public informed of significant new information.
Reporting Problems to the FDA
The FDA encourages users to report any adverse events or suspected adverse events experienced with the Alinity m SARS-CoV-2 AMP Kit or the Alinity m Resp-4-Plex AMP Kit.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Generally, as specified in a test’s EUA, device manufacturers must comply with the applicable Medical Device Reporting (MDR) regulations. Authorized laboratories should report as provided in the EUA conditions of authorization.
- Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
Contact Information
If you have questions about this letter, contact [email protected].
