Frank Stoppenbach asks the FDA’s Center for Biologics Evaluation and Research for Scientific Papers Validating HIV Tests

Dear Mr. Stopinback,

Per our phone conversation,

• Weiss SH, Goedert JJ, Sarngadharan MG, Bodner AJ, AIDS Seroepidemiology Collaborative Working Group, Gallo RC et al. Screening test for HTLV-III (AIDS agent) antibodies. Specificity, sensitivity, and applications. JAMA 1985; 253:221-225.
• Sarngadharan MG, Popovic M, Bruch L, Schupbach J, Gallo RC. Antibodies reactive with human T-lymphotropic retroviruses (HTLV-III) in the serum of patients with AIDS. Science 1984; 224:506-508.
• Schupbach J, Popovic M, Gilden RV, Gonda MA, Sarngadharan MG, Gallo RC. Serological analysis of a subgroup of human T-lymphotropic retroviruses (HTLV-III) associated with AIDS. Science 1984; 224:503-505.

Sincerely,

Chris Middendorf
Chief
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration

Dear Mr. Middendorf:

The information you provided has been very helpful, and I find it repays re-reading. Your prompt response was greatly appreciated.

Do those references constitute the validation and basis for all HIV antibody tests approved by the FDA since 1985, or have they been superseded by subsequent work?

Sincerely,

Frank Stoppenbach

Mr. Stoppenbach,

Sorry for the delay, I’m still waiting for an answer from the Office of Blood.

Sincerely,

Chris Middendorf
Chief
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration

Hi. Just following up on the status.

Do you have an answer yet from the relevant office? There are proposals to simplify the procedure required for HIV testing, and I would like to undersand the most current validation for the tests.

Will greatly appreciate the information.

Frank Stoppenbach

Dear Mr. Stoppenbach,

I apologize for the delay. I have discussed this issue with our Office of Blood Research and Review and it appears for your purposes, we are not aware of additional publications which are relevant to your needs.

If you require specific approval information, that request must be made through the Freedom of Information Act (FOIA). Information on submitting a request under FOIA is available on our website at: fda.gov/opacom/backgrounders/foiahand.html

Sincerely,

Chris Middendorf
Chief
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration