CMED/GenProbe comments from Yahooers...
Gen-Probe
by: boater_hagz 1883 of 1891
Parts of an article on Gen-probe......
First NAT Positive, Serologically-Negative HIV Donor Identified in Milwaukee.
The Blood Center of Southeastern Wisconsin is the first blood center in the nation to identify an HIV-positive, standard test-negative potential blood donor using nucleic acid testing (NAT), the Milwaukee Journal Sentinel reported yesterday (8/5/99). NAT may have caught the infection just days after the man became infectious-so early it took two more weeks for the infection to progress enough for standard tests to confirm it, Janice McFarland, MD, vice president of medical services at the blood center, told the Sentinel. The HIV infection was officially confirmed on Tuesday, after the donor had tested positive on HIV antibody and antigen EIA tests that were confirmed by a Western Blot test.
Researchers have predicted that on average, NAT can detect HIV within five days of the virus becoming infectious. The original HIV antibody test detects the disease only after antibodies to the virus develop, which on average is 22 days after infection but can be as long as six months. A more recently-implemented donor screening test-the p24 antigen test-can detect the virus on average within 16 days of infection, Dr. McFarland said. The NAT test shortens this "window of opportunity," the time when infection and transmission are possible but no test can detect it, to mere days, she noted.
"This one case is not enough to say whether NAT is or is not worth it. But it certainly was important having it in this case. We prevented transmission of HIV, and NAT was the only thing that prevented it," Dr. McFarland said. Dr. McFarland said it came as a surprise to be the first blood center to detect HIV using NAT. Under three Investigational New Drug (IND) research protocols approved by the Food and Drug administration, all US blood centers began screening donors this year by NAT. Three California-based companies-Roche Molecular Systems and an alliance between Gen-Probe and Chiron Corporation-developed the technologies upon which NAT is based. These companies are providing blood center laboratories with the software, test kits and support to conduct the NAT studies. Last fall, ABC chose 16 member labs to lead the NAT studies, consolidating the studies to make the most effective use of the investment in facilities, equipment, materials and labor NAT testing requires. Three labs are participating in the Gen-Probe/Chiron NAT study, and 13 are participating in the Roche study. These labs are performing research for all ABC members and about 150 hospitals that collect blood-or about 55 percent of the US blood supply. The American Red Cross is participating in a third NAT research study with Chiron and Gen-Probe.
All blood service organizations are bound by FDA's IND regulations, which prohibit advertising, marketing or safety claims as a result of NAT research. FDA has not licensed the test, but has encouraged its development through the IND process.
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Gen-Probe Continued
by: boater_hagz 1884 of 1891
What the preceding article should tell you is that CMED has a superior HIV blood test in Gen-probe than what is out there otherwise. Looks like Gen-Probe is moving closer to FDA approval / License stage as more evidence comes out to support the test.
Best Regards,
RH
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Posted: 08/11/1999 09:46 am EDT as a reply to: Msg 1883 by boater_hagz |
