According to a November, 2005 joint press release from UNAIDS (Joint United Nations Programme on HIV/AIDS) and the World Health Organization, the number of people living with HIV globally reached an estimated high of 40.3 million people in 2005, with over 3 million deaths caused by AIDS. The latest data from the Centers for Disease Control shows that over one million people in the United States are now living with HIV/AIDS and with 24 27% undiagnosed and unaware of their status. To address the large number of people who are unaware of their status, considerable progress has occurred in prompt, definitive screening for HIV in the physicians office or clinic setting.
According to the CDC website, when standard testing was used during year 2000, 30% of persons who tested HIV-positive and 39% of persons who tested HIV-negative did not return to learn their HIV status. Additionally, Abbott Diagnostics states on their website that each year, 8,000 HIV-infected people who come to public clinics for HIV testing do not return to receive this critical test result. By contrast, a rapid test will allow the patient immediate access to emotional counseling and medical treatments, as well as lifestyle education to address the further spread of HIV. The ability to rapidly screen for HIV at the point-of-care is likely to yield considerable emotional and medical benefits.
During the March 10, 2006 FDA Blood Products Advisory Committee meeting, studies were proposed to support the approval of over-the-counter home use of HIV test kits, bringing this possibility one step closer to reality. While the mail-in Home Access HIV-1 Test System received PMA in 1996, the pros and cons of at-home HIV testing with rapid results have been debated for years. Medical advancements in AIDS treatment and the ongoing movement to limit the spread of HIV are compelling arguments for rapid home HIV testing. A highly important factor, however, rests in the performance of the rapid test technology when it is used in the home.
Rapid HIV tests come in several formats: agglutination, flow through cassette, solid phase, and Immunochromatographic strip (ICS) tests. The tests that are commercially available today cover the range of specimen choice: whole blood, plasma, serum, and, since March 2004, oral swabs. Regardless of format or specimen, rapid HIV tests screen for antibody to HIV, and not for virus or viral load. Positive results require confirmation via standard EIA methods and, if positive, a further definition of the specific viral strain is required.
The Bio-Rad Multispot HIV-1/HIV-2 Rapid Test was approved by the FDA for clinical use in November, 2004. A landmark product, it was the first rapid HIV test to offer both detection (screening) and differentiation of HIV-1 and HIV-2 antibodies. The Multispot HIV-1/HIV-2 Rapid Test can be used with fresh and frozen plasma and serum, and takes about 10 minutes to perform. Sensitivity characteristics versus the Western Blot are impressive 100% for both HIV-1 and HIV-2 antibodies. Bio-Rad also offers standard testing systems (Western Blot and microplate format EIA) for screening and confirmatory testing.
Another ground breaking product in this arena is the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, marketed by Abbott Laboratories, Abbott Park, Ill. The OraQuick line was first introduced in 2002, and was the first CLIA-waived, rapid, point-of-care test designed to detect antibodies to HIV-1 using finger stick whole blood or venipuncture whole blood specimens. The updated OraQuick ADVANCE Rapid HIV-1/2 Antibody Test FDA approved in October 2004, can detect both HIV-1 and HIV-2 antibodies using oral fluid, finger-stick or venipuncture whole blood or plasma specimens. The test requires no specialized laboratory instrumentation, is portable, and can be st ored at room temperature, providing convenience in any setting.
While HIV/AIDS remains the most widespread and intractable epidemic in human history, progress is occurring. The ability to disseminate reliable testing to locations where people routinely obtain their medical care is fundamental to such progress and the use of devices such as those reported here will bring great benefit to many people in this urgent disease crisis.
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