The US Food and Drug Administration (FDA) recently issued a public advisory on the use of unapproved HIV blood sample self-collection kits. This announcement raises concerns about the safety, accuracy, and effectiveness of these kits, which are being marketed without FDA authorization. Here’s what you need to know and how it impacts consumers, healthcare professionals, and organizations involved in HIV testing programs.

Why It Matters

In the US, self-collection kits for HIV blood samples are being promoted without the necessary FDA clearance or approval. The FDA cannot confirm whether these devices meet the required standards for safety and performance with the lack of this oversight. 

HIV self-testing is an important tool for increasing access to diagnosis, but unauthorized kits may produce unreliable results, leading to potential misdiagnoses or delays in care.

Key Takeaways

No FDA-Authorized Blood Sample Self-Collection Kits for HIV Testing Exist

There are no FDA-approved self-collection kits for blood samples, including dried blood spots, for HIV testing on the market currently. Issues such as specimen collection quality, shipping conditions, and sample stability remain unregulated for unauthorized kits, raising serious concerns about their reliability.

Specific Advisory to BlackFly Investments

On October 11, 2024, the FDA issued a warning to Blackfly Investments, LLC, operating as Molecular Testing Labs, for marketing a dried blood spot card self-collection kit without proper authorization. This action underscores the FDA's commitment to protecting public health by preventing the sale of unregulated diagnostic devices.

Recommendations for Consumers and Healthcare Providers

For Consumers: If you’ve used an unauthorized HIV blood sample self-collection kit, consult with your healthcare provider to discuss your results and determine if retesting is necessary.

For Healthcare Professionals: Be vigilant when reviewing test results from unauthorized kits and consider advising patients to undergo retesting through FDA-approved methods.

Consumers and healthcare professionals are encouraged to report issues or suspected inaccuracies with these kits via the FDA’s MedWatch Voluntary Reporting Form.

FDA-Authorized Alternatives for HIV Testing

While self-collection blood sample kits for HIV testing lack FDA authorization, there are several reliable, FDA-cleared alternatives available:

• In-Clinic Testing: Includes nucleic acid tests (NAT) for HIV viral RNA and serological tests for detecting HIV antibodies or proteins (p24).
• At-Home HIV Testing: The OraQuick In-Home HIV Test, which uses oral fluid to detect HIV antibodies, remains the only FDA-approved self-test currently on the market.

These options provide robust and validated methods for HIV detection, ensuring both safety and accuracy.

What’s Next

The FDA is actively engaging with manufacturers to facilitate the development and authorization of more at-home testing solutions, including self-collection kits. These efforts aim to improve accessibility to accurate HIV testing while maintaining high safety and performance standards.

Read the FDA’s public advisory here for more information.