FDA mandates the use of antigen based tests for HIV in all registered blood and plasma centers.SCOTTSDALE, Ariz.--(BUSINESS WIRE)--Nov. 14, 1995--At a workshop put on by The Council of Community Blood Centers at the NH Campus in Bethesda, Md. on Tuesday, Nov. 7, 1995, the memo from the FDA's director of the Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, which is in the United States Department of Health and Human Services. , issued Aug. 8, 1995, was circulated to all attendees. This memo recommends that all registered blood and plasma establishments will have to begin HIV-1 antigen testing of all blood in current inventory, and that all prospective donors will have to be tested with HIV-1 antigen test in an all-out effort to close the "window" between exposure and detectability of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. . The Aug. 8 memo recommendations supersede the recommendations in effect from FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. since Oct. 4, 1989. This new mandate is to go into effect by December 1995. The new recommendations come as a result of reevaluation of the role of antigen testing in the light of four documented instances of HIV transmission by HIV-1 antigen-positive blood donations from three HIV-1 antibody-negative donors, and a reevaluation of estimates of residual risk Residual risk Related: Unsystematic risk of HIV transmission in antibody screened blood and the efficacy of antigen testing to detect seronegative seronegative /se·ro·neg·a·tive/ (-neg´ah-tiv) showing negative results on serological examination; showing a lack of antibody. se·ro·neg·a·tive adj. , infectious donations. The problem is that the current P24 antigen p24 antigen AIDS The 24 kD core antigen of HIV-1, which is linked to clinical AIDS; p24 is the earliest marker of HIV-1 infection, and detectable days to wks before seroconversion to anti-HIV-1 antibody production, detected by ELISA. tests available take 3-5 hours to perform, are labor intensive and, in truth, only close the "window" by a few more days. Another problem is that before issuing licenses to provide test kits to blood banks, companies with P24 antigen tests will have to prove to the FDA that they have an inventory of 5 million tests and can produce 2 million tests per month. Once again, BFTI BFTI Brownfields Tax Incentive has been proven to be right on the money. BFTI has been right on target with its forecasts of the HIV testing market. We have categorically stated that IFA Immunofluorescent assay (IFA) A blood test sometimes used to confirm ELISA results instead of using the Western blotting. In an IFA test, HIV antigen is mixed with a fluorescent compound and then with a sample of the patient's blood. was the most sensitive, specific and accurate means to test HIV antibodies. Accordingly, this summer (July 7, 1995) the Centers for Disease Control issued new guidelines for testing pregnant women for HIV, in which they virtually endorsed Immuno Fluorescence Assays for HIV as the confirmatory test of choice over Western Blot. BFTI already has one FDA IFA test ready to use on the Mehica GP120 and is in the process of getting FDA approval on a second test developed by Virion virion Entire virus particle, consisting of an outer protein shell (called a capsid) and an inner core of nucleic acid (either RNA or DNA). The core gives the virus infectivity, and the capsid provides specificity (i.e., determines which organisms the virus can infect). . BFTI has stated that of paramount importance to the FDA and the CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation was closing the window between exposure to HIV and detecting an HIV-infected person. BFTI's test fulfills FDA's request for new technology to solve this problem. As we stated, BFTI's antigen test will detect an infected individual only four days after exposure. BFTI's test takes minutes to run, is not labor intensive and is cost competitive. To the best of our knowledge, BFTI is the only company that has a product that satisfies both the CDC's requirement for a fluorescence test and the FDA's recommendation for an antigen test. This is why BFTI has developed its revolutionary new antigen-based Mehica GP120(a) and HIV Packaged Antigen Kits(b). BFTI's new test will reliably detect an infected individual within four days of exposure. BFTI's test takes minutes, not hours, reduces labor costs, costs hundreds less than current tests and is easy to use. BFTI's agreement with Virion means that the test samples needed to meet the demand will be available. -0- (a) The basic GP120 detector system prototype has been completed. Certain proprietary peripheral components are in the process of being integrated. It will be completed in the near future. (b) Although additional testing will be required to obtain FDA approval, BFTI will be ready to offer its test into the overseas market in the very near future. CONTACT: Bio Fluorescent Technologies Inc., Scottsdale George, 800/870-1233 or Margaret, 800/665-1335 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion