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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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March 26, 2004 Approval Letter - OraQuick Rapid HIV-1/2 Antibody Test

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

March 26, 2004

Ms. Eve Damiano
OraSure Technologies
220 East First Street
Bethlehem, PA 18015-1360

Re:     BP010047/10
Product:     OraQuick Rapid HIV-1/2 Antibody Test
Device Code:     MTL

Date Received: 30-SEP-03

Dear Ms. Damiano:

The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has completed its review of your premarket approval supplement (PMA supplement) for the OraQuick Rapid HIV-1/2 Antibody Test. This supplement is to allow for an added labeling claim for the detection of antibodies to HIV-1 and HIV-2 in plasma specimens and the detection of HIV-1 antibodies in oral fluid specimen. We are pleased to inform you that the PMA supplement is approved subject to the conditions described below:

 

  1. OraSure has agreed to perform studies to examine the influence of alcohol consumption, mouthwash use, brushing of teeth, or eating, immediately prior to administering the test on sensitivity and specificity of the OraQuick Rapid HIV-1/2 Antibody Test using oral fluid specimens. A minimum of 10 infected individuals and 10 uninfected individuals should be used for each condition.

     

  2. OraSure has agreed to perform studies to examine the influence of unrelated medical conditions on sensitivity and specificity of the OraQuick Rapid HIV-1/2 Antibody Test using oral fluid specimens. A minimum of 10 individuals should be tested for each condition from a minimum of 10 conditions, including, for example, smallpox and influenza vaccines, individuals with autoimmune disease, and individuals infected with oral Candida albicans, HBV, HCV, HTLV-I/II, EBV, CMV, and HSV. To determine the effect of these conditions on sensitivity, specimens may be collected from individuals not infected with HIV and tested with developer solution spiked with an HIV-positive plasma or serum specimen to give a low level of reactivity on the OraQuick Rapid HIV-1/2 Antibody Test.

If you have any questions concerning this approval order, please contact Hilary Cooper at (301) 827-5307.

Sincerely,

--- signature ---

Hira L. Nakhasi, Ph.D.
Director
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research