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FDA Basics Webinar: Role of FDA in HIV Diagnosis

DATE: December 1, 2015
TIME: 1:00pm EST
LENGTH: 30 minutes

The United States Food and Drug Administration (FDA) regulates the tests that detect infection with Human Immunodeficiency Virus (HIV), the virus that causes AIDS (acquired immune deficiency syndrome). AIDS is a serious disease that can be fatal because the body has lost the ability to fight infections and cancers.

FDA assures that diagnostic and blood donor screening tests for HIV are sensitive and specific for the detection and/or quantitation of HIV in blood and other body fluids, including urine and oral fluid. Diagnostic tests, such as enzyme immunoassay (EIA) and Western Blot antibody tests, are used to diagnose HIV exposure or infection in individuals. Blood donor screening tests, including EIA and nucleic acid tests, are used to detect blood collected from infected individuals, and prevent it from entering the blood supply. Patient monitoring tests, such as viral load and genotyping tests are used for prognosis and therapeutic management.

On Tuesday, December 1st, marking World AIDS Day, FDA hosted a webinar that explained the role of FDA in HIV diagnosis. Pradip N. Akolkar, PhD, from the Division of Emerging and Transfusion Transmitted Diseases in the Office of Blood Research and Review with FDA’s Center for Biologics Evaluation and Research, discussed how FDA regulates HIV diagnostic, monitoring, and blood donor screening tests.

After the presentation, there was an opportunity to ask questions.

Presentation slides: Role of FDA in HIV Diagnosis

View recorded webinar: https://collaboration.fda.gov/p2oruni654s/

Page Last Updated: 03/14/2019
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