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Vaccines, Blood & Biologics

September 18, 2001 Companion Approval Letter for Source Plasma - UltraQual HIV-1 RT-PCR Assay

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

September 18, 2001

Our STN: BL 102482/1300

Mr. J. Claude Miller
Senior Vice President
Quality and Regulatory Compliance
Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles, California 90032

Dear Mr. Miller:

Your request to supplement your Biologics License Application (BLA) for human Source Plasma to include the National Genetics Institute UltraQualHuman Immunodeficiency Virus Type 1 Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay (UltraQualHIV-1 RT-PCR Assay), when used in combination with FDA approved pooling and resolution algorithms, as indicated for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) ribonucleic acid (RNA) in pooled human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples, has been approved. This method may be used as an alternative to currently licensed HIV-1 p24 antigen tests for screening Source Plasma. The UltraQual HIV-1 RT-PCR Assay will be performed at National Genetics Institute, 2440 S. Sepulveda Boulevard #130, Los Angeles, California 90064.

This information has been placed in your biologics license file. Please keep a copy of this letter available for review at the time of FDA inspections.

Sincerely yours,


--- signature ---


Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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