Medical Device Link.

Originally Published IVD Technology March 2003

INDUSTRY NEWS

Richard Park

Recent developments in HIV screening point to an emerging trend toward faster, noninvasive, and easy-to-use tests that provide alternative testing options and are more readily available to high-risk populations.

FDA has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to the OraQuick rapid HIV-1 antibody test by OraSure Technologies Inc. (Bethlehem, PA). With this waiver, the OraQuick test can be used by a greater number of sites, including outreach clinics, community-based organizations, and physicians’ offices.

“We are very excited about the CLIA waiver and the opportunity to make the OraQuick test available to all who need it,” says Mike Gausling, chief executive officer at OraSure. 

In an article that appeared in the January/February 2003 issue (“Rapid HIV test obtains FDA approval”), IVD Technology reported that OraSure had received FDA approval to manufacture and market its OraQuick test for the detection of HIV-1 antibodies in finger-stick whole blood samples. Under this initial approval, the test was categorized as moderately complex and was restricted to use only in the nearly 40,000 laboratories that are certified under CLIA to perform moderately complex diagnostic tests. At that time, Health and Human Services secretary Tommy G. Thompson strongly urged OraSure to submit an application for a CLIA waiver in order to expand the potential use of the test.

“Ensuring the widespread availability of a rapid HIV test to outreach services in communities where people are at high risk of HIV is vital to the public health,” says Thompson. “Without [the CLIA waiver], this test would be limited to use in laboratory settings where many high-risk people do not go for testing.”

In another development, a study that was conducted by Johns Hopkins University (Baltimore) utilizing the HIV-1 EIA and Western blot urine tests by Calypte Biomedical Corp. (Alameda, CA) determined that urine-based HIV screening is an effective testing method. 
Published in the December 2002 issue of the Journal of Acquired Immune Deficiency Syndromes, the study concluded that, “Urine-based screening for HIV infection in high-prevalence inner-city communities can be an effective tool for identifying and treating infected persons who are unaware of their infection.”

The study also stated that, “Although it is believed that targeting of known prevention strategies to those persons of highest risk could significantly reduce the number of new cases of HIV infection each year, a major barrier to such targeting is the estimated 300,000 people infected in the United States. who are unaware that they are infected. Therefore, there is an urgent need for new methods to screen and test populations at high risk for this infection.”

“We are very excited that third-party analyses continue to recognize the merits of urine-based testing,” says Toby Gottfried, chief science officer at Calypte. “This study’s findings are consistent with those observed in other postmarket studies which found that the availability of urine-based testing as an option resulted in greater acceptance of voluntary testing.”

Industry analysts believe that these faster and noninvasive tests represent a trend in HIV testing that will continue to be developed in the IVD industry.

“What we’re seeing is an evolution toward point-of-care rapid testing that provides people with more-immediate results and allows people to get the appropriate treatment much quicker than they have with lab-based tests,” says William Bruckner, vice president of strategic marketing at OraSure. “So the market is definitely moving toward less-invasive, rapid testing for HIV that provides results in minutes and is able to reduce the overall cost of the current system and allow for more of that money to be placed in actually treating people with HIV. Obviously right now lab-based testing is still the dominant player within the HIV category. I think, though, that what we’ll find is that there are circumstances where a rapid test makes more sense.”

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