Health Alert
BE AWARE OF SCAMS ADVERTISING UNAPPROVED COVID-19 TESTS

Summary

The Division of Public Health (DPH) is issuing this health alert to advise that health care practitioners are being contacted by certain laboratories and commercial manufacturers advertising COVID-19 diagnostic and serology tests that are not approved or granted Emergency Use Authorizations (EUA) by the U.S. Food and Drug Administration (FDA).

Background

Many of these communications may be scams and DPH advises all health care professionals to be alert to this new type of fraud.

Health care professionals should not use diagnostic or serology tests that are not approved or have not been granted EUAs by the FDA, and should immediately stop using COVID-19 tests found on the FDA’s lists of tests for which EUA applications have been denied (the “removed” test lists). All testing must be performed in compliance with the Occupational Health and Safety Administration and Clinical Laboratory Improvement Amendments regulations or if conducted in a clinical laboratory setting, in accordance with standards set forth by the Commission on Office Laboratory Accreditation.

The FDA recommends that health care providers:

• Verify here prior to use whether any tests provided are approved by, or have been granted EUAs from, the FDA;
• Monitor and review the FDA’s “removed” test lists; 
• 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-approved or FDA-authorized test;
• Remove from stock any remaining tests that are not FDA approved or authorized, including those listed on the FDA’s “removed” test lists; and
• Report any issues with COVID-19 tests to the FDA.

Continuing to use tests found on the “removed” test lists could put patients’ health at risk and may subject health care professionals to disciplinary action by licensing boards. Therefore, be sure to frequently check the FDA’s “removed” test lists and the list of COVID-19 tests that the FDA has approved, above.
 

Reporting 

All COVID-19 test results from any laboratory must be reported to DPH via the Delaware Electronic Reporting Surveillance System (DERSS). Providers must confirm with their designated laboratories that they have the ability to transmit results to DERSS through approved methods – additional information regarding, and questions about, laboratory reporting can be requested through reportdisease@delaware.gov.

Failure to comply with regulations surrounding the reporting of testing may result in fines ($100.00 - $1,000.00 per violation under DHSS’ authority under 16 Del. C. 107(a)) and/or other penalties as deemed necessary and appropriate.

If you have information about or are the victim of any of these scams, please submit a complaint to the FDA either by email at FDA-COVID-19-Fraudulent-Products@fda.hhs.gov or via the FDA’s reporting systems here (English) or here (Spanish). Also contact the Office of Health Systems Protection at HSPContact@delaware.gov.
 

Additional Information

Health care providers can find additional information in the FDA’s Letter to Clinical Laboratory Staff and Health Care Providers and on the FBI’s alert, FBI warns of Potential Fraud in Antibody Testing for Covid-19

Additionally, as testing — both laboratory and point-of-care — becomes increasingly available in the ambulatory and outpatient care space, it is critical that providers remain compliant with regulations regarding the reporting of SARS-CoV-2 testing. The Department of Health and Social Services’ March 10, 2020 order requiring all labs to immediately report all tests and all results to DPH remains in effect. All COVID results, positive AND negative, are reportable.

A list of private and commercial laboratories that are currently compliant with DPH reporting can be found at https://coronavirus.delaware.gov/wp-content/uploads/sites/177/2020/09/Currently-Compliant-Labs-Reporting-to-DPH.pdf. 

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