**** HEADS UP DUBLIN ***
CDC LAUNCHING NEW ERA IN TESTING BY GIVING OK TO RAPID SCREENING TESTS !
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AIDS Alert...new fingerstick tests will bring access to the streets.
In a move that is likely to have profound and far reaching consequences, the Center for Disease Control and Prevention has made an about-face on rapid HIV screening tests.
In the Feb 27, 1998, issue of Mortality and Morbidity Weekly Report, the CDC will recommend a change in the US Public Health Service policy. It will urge that under at least some circumstances, health care providers should be able to disclose provisional results of HIV tests, instead of making patients wait two weeks while a confirmatory test is performed.
The new recommendations are expected to be incorporated into regulations by the U.S. Food and Drug Administration ( FDA ). When that happens, the effect will be the opening of a vast new market in the United States for rapid HIV screening tests, CDC experts say.
Though dozens of rapid tests are already in widespread use abroad, scant incentive exists for test manufacturers to mount the expensive clinical trials needed for approval in the United States, because the FDA at present prohibits the disclosure of provisional rapid- test results, says Bernard M Branson, MD MPH, medical epidemiologist at the National Center for HIV,STD,and TB prevention at the CDC, and chief architect of the new CDC recommendations.
With a new policy in place, many new rapid tests for HIV will be submitted for FDA approval, experts say. Most of the new tests are simple fingerstick tests that incorporate a new technology perfected within the last year, and which-intheory could be used by anyone, from the outreach worker to consumers of home test kits.
Two new tests are in Clinical trials, a third is already available and another is expected to become available within the next year or so, CDC experts say......
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(Trinity Uni-gold HIV in Clinical trials is one of the tests sited in this report and I will post more this evening )
~~~~ to be continued ~~~~ |
