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  1. Safety & Availability (Biologics)

Important Information on Use of Unapproved Human Immunodeficiency Virus (HIV) Blood Sample Self-Collection Kits

October 29, 2024

Summary of the Issue:

The Food and Drug Administration is advising the public, including consumers, health care professionals, and community-based organizations, health departments, and clinics where HIV self-testing programs are available, that HIV blood sample self-collection kits are being marketed in the United States without required FDA marketing authorization. Without appropriate regulatory review and authorization, FDA lacks assurance of the safety and effectiveness of these medical devices. Therefore, the Agency does not know whether use of these HIV blood sample self-collection kits will reliably produce valid, accurate results when samples obtained with these kits are used in HIV testing.

HIV Blood Sample Self-Collection Kit Information for Health Care Professionals and Consumers:

  • Currently, there are no self-collection kits available on the market that FDA has authorized to collect blood samples, including dried blood spots, for HIV testing. Self-collection raises several issues of importance, including, for example, whether the user can safely and properly collect the specimen, if the sample has been properly shipped, and if there is adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions.
  • On October 11, 2024, FDA issued a Warning Letter to Blackfly Investments, LLC doing business as Molecular Testing Labs (MTL). The Warning Letter notified the firm that the HIV serological diagnostic dried blood spot card self-collection kit MTL is offering for sale lacks required FDA marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act. FDA has not authorized this self-collection kit for any use, including for use in HIV serological diagnostic testing.
  • Individuals who used an HIV blood sample self-collection kit that is not authorized by FDA should discuss with their health care provider the results of testing performed on samples collected with that kit and whether retesting is medically indicated.
  • FDA encourages consumers and health care professionals to report any problems they experience using an HIV blood sample self-collection kit - including suspected inaccurate test results obtained using samples collected with the kit - through the Medwatch Voluntary Reporting Form.

    Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
  • FDA has cleared or approved several tests, including tests that detect HIV viral RNA (Nucleic Acid Tests, or NAT) and tests that detect HIV protein (p24) and antibodies against HIV (serological tests), for clinical use as an aid in diagnosis of HIV infection. These tests are available at numerous locations, including clinics and HIV outreach testing sites.
  • For individuals who prefer to test for HIV at home or in another private location, FDA has approved the OraQuick In-Home HIV Test, an over-the-counter (OTC), self-test that tests oral fluid for the presence of HIV antibodies. The OraQuick In-Home HIV test is the only FDA-authorized HIV self-test currently available in the United States.

FDA will continue to monitor the situation closely and keep the public informed if new information becomes available.

Consumers and health care providers who have questions may contact FDA’s Center for Biologics Evaluation and Research (CBER) at: ocod@fda.hhs.gov.

FDA is actively engaged with device manufacturers and interested in working with additional manufacturers towards the goal of authorizing more home use tests, tests for use with at-home sample collection, and self-collection kits for HIV detection. Manufacturers that have questions about FDA regulations may contact CBER at: industry.biologics@fda.hhs.gov.

 

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