FDA Approves New Test to Screen for HIV and HCV in Donated Blood
The FDA approved a new test to screen donated blood for HIV and hepatitis C virus (HCV) RNA on Wednesday, May 23, 2007. The Procleix Ultrio Assay, manufactured by GenProbe, Inc. and marketed by Chiron Corporation, is an in vitro test that can identify both viruses in individual samples or in pools of up to 16 samples at a time. This assay uses transcription-mediated amplification to detect the viruses that allows for the amplification of the target by a billion-fold in one hour's time.
In addition, this test amplifies genetic material as opposed to antibodies. This is significant because it takes a high viral load and quite some time for the immune system to mount an infection response that produces enough antibodies for current standard tests to detect. The Centers for Disease Control and Prevention (CDC) estimates that this takes between 3 and 6 months for HIV infection and up to 3 months after symptoms appear for HCV infection. The assay's ability to directly amplify viral genetic material, in contrast to traditional screening methods, reduces the window period between infection and the ability to detect for HIV infection by 50% and for HCV infection by 70%. In fact, clinical studies leading to the approval of the assay identified seven HIV infected samples and 88 HCV infected samples that traditional screening tests had not identified due to their recent infection.
This test is approved for the screening of donated blood, as well as individual organ donations, for HIV and HCV. Coinfection with HCV and HIV is a common and serious occurrence. The CDC reports that 25% of all people with HIV infection are also infected with HCV. That percentage increase to 50-90% in HIV-infected injection drug users. There is no word as of yet if this assay will be used as a method to diagnose people potentially infected with either HIV or HCV in the future.
National Caribbean-American HIV/AIDS Awareness Day: June 8, 2007
June 8, 2007, marks the second annual observance of National Caribbean-American HIV/AIDS Awareness Day (NCAHAAD). This day is dedicated to raising awareness of HIV/AIDS in the Caribbean-American community. In addition, this day is devoted to encouraging Caribbean-American and Caribbean-born individuals across the United States to get educated about HIV/AIDS and how to stay healthy.
AIDSinfo is pleased to participate in the commemoration of this important day. Check out the new AIDSinfo Caribbean-American HIV/AIDS Awareness Day 2007 Web page, which includes links to Web sites that provide information about Caribbean health and HIV/AIDS; NCAHAAD events; and ongoing research among minority communities.