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New HIV saliva test kit to hit UK markets

posted 9-1-97

Health professionals in the United Kingdom will have the option of administering a new, bloodless HIV test by early next year.

The Saliva-Strip HIV test kit, recently approved for sale by the health authorities in the United Kingdom, uses saliva collected on a strip of material under the tongue to detect HIV antibodies. The test is one of several newly approved HIV testing products manufactured by Saliva Diagnostic Systems Inc. in Vancouver, Washington. The company also plans to market Hema-Strip HIV, a test that uses a small drop of whole blood from a finger stick.

Both tests provide results in less than 15 minutes, require no outside equipment, and have an 18-month shelf life without refrigeration, said Joni O’Donahue, spokesperson for Saliva Diagnostic. However, Saliva-Strip is noninvasive, which could mean the test is safer for health professionals to administer. "There have never been any documented cases of HIV transmission by saliva alone," O’Donahue said.

The disadvantages of saliva testing include a slightly longer collection time—it takes about three or four minutes to administer Saliva-Strip compared to 20 seconds for a finger stick test. Saliva testing is also a fraction less accurate than blood testing—99.4 percent accurate compared to 99.8 percent.

Saliva Diagnostic expects it will sell both kits on the U.S. market, but O’Donahue said approval will probably take longer here than in the United Kingdom because of the Food and Drug Administration’s rigorous and expensive approval process.

Distribution of both kits will be managed by Advanced Pathology Services, a worldwide operation with 26 labs and four London facilities. Marketing will be limited to hospitals, clinics, labs, and healthcare authorities.