Coming to your clinic: Candidates for rapid tests
With the shift in U.S. Public Health Service policy on rapid HIV screening tests, new manufacturers are expected to begin entering the U.S. market in the next year, experts say. Here’s a look at what’s here, on the way, or possibly arriving soon.
Murex, a Norcross, GA-based firm [(800) 334-9332], makes an enzyme immunoassay that uses serum or plasma, called SUDS HIV-1. The test is already approved for U.S. use (although current FDA regulations prohibit the immediate report of reactive tests). List price, $10; sensitivity, 99.9%; specificity, 99.6%. It is used in the United States in instances of occupational exposure, with mothers presenting in labor with no history of prenatal care, or in emergency-room situations.
Trinity Biotech [(716) 483-3851], based in Dublin, Ireland, with U.S. headquarters in Jamestown, NY, expects its Uni-Gold HIV test to win FDA approval in the next year. List price, $50 for 20 tests. Now sold abroad, a combination test for HIV 1 and 2; uses plasma, serum, or whole blood. Ten-minute incubation. Also from Trinity, Rapid Saliva Card, which tests for HIV 1 and 2 with saliva; Trinity has no plans at present to bring that test to U.S. markets, spokesmen say.
Sanofi Diagnostics, Pasteur (based in Paris), along with its U.S. subsidiary, Genetic Systems [(206) 728-4900], based in Redmond, WA, makes the MultiSpot test, formerly known as Genie. In widespread use abroad, and the CDC’s choice for "tiebreaker" in two-test rapid studies. Costly, in part because it distinguishes between HIV 1 and 2, MultiSpot might list here for $10 to $15, says Patrick Coleman, MD, test developer and spokesman. MultiSpot’s makers are wary of getting burned again by the U.S. marketplace, where 10 years ago they gambled (and lost) on an OTC niche that turned out to be nailed shut. Meanwhile, half a dozen U.S. states are trying to get hold of the test by importing it as an "investigational device," a plan experts doubt will work.
Saliva Diagnostics Systems [(360) 696-4800], in Vancouver, WA, is about to bring three tests to market in Canada this year, each of them well-liked by U.S. experts. Paul Slowey, PhD, Saliva Diagnostics’ chief operating officer and vice president of marketing, dreams of finding a U.S. backer as well. Sero.Strip, a serum test for HIV 1 and 2, might list here for $4 to $5, Slowey says; it features 99.6% sensitivity and 99.8% specificity. Hema.Strip, a fingerstick test that can use whole blood, might sell here for about $10; it has 99.6% sensitivity, 99.9% specificity, and 20-minute incubation time. Saliva.Strip, which could cost $10 to $12, has 99.4% sensitivity and specificity, and uses a pad on a stick to collect plain saliva, which is filtered, buffered, and incubated for 20 minutes.
Abbott Laboratories [(847) 937-3357], in Abbott Park, IL , is tight-lipped about two whole-blood, fingerstick-type tests now in clinical trials, but is said to be eager to bring the tests to market.
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