** Coming to Your Neighborhood Clinic or Wallgreen Drug Store **
With the shift in US Public Health Service policy on rapid HIV screening tests, new manufacturers are expected to begin entering the US Markets in the next year, experts say.. Here's a look at what's here, on the way, or possibly arriving soon...
Candidates for RAPID TESTS.
*** MUREX, a Norcross, GA based firm makes an enzyme immunoassay that uses serum or plasma, called SUDS HIV-1. The test is already approved for US use( although current FDA regulations prohibit the immediate reporting of reactive tests ). List price $ 10.00
sensitivity 99.9%....specificity 99.6 % It is currently used in the United States in instances of occupational exposure, with mothers presenting in labor with no history of pre-natal care, or in emergency room situations.
*** Trinity Biotech, based in Dublin, Ireland. with U.S. Headquarters in Jamestown, N.Y., expects it's Uni-gold HIV test to win FDA approval in the next year.List price ...... $ 50 for 20 tests. Now being sold abroad. A combination test for HIV1 and HIV 2 uses plasma, serum or whole blood. Ten minute incubation. Also from Trinity. Rapid Saliva Card, which tests for HIV1 and HIV 2 with Saliva. Trinity has no plans to bring that test to US markets.
**** Sanofi Diagnostics, Pasteur ( based in Paris ) along with it's U.S. subsidiary, Genetic Systems based in Redmond , Washington makes the ** Multi-Spot test **. In widespread use overseas and the CDC's choice for " tiebreaker " in two test rapid studies.
Costly, in part because it distinguishes between HIV 1 and HIV -2, MultiSpot might retail here for $ 10.00 or $ 15.00 says Dr.Patrick Coleman , test developer
*** Saliva Diagnostics Systens of Vancouver, WA is about to bring three test to market in Canada this year, each of them well liked by U.S. experts Paul Slowey PhD, SDS dreams of finding US backer as well. Sero-strip, a serum test for HIV 1 and HIV -2 might list for $ 4 to $ 5.00/
Saliva-Strip, which could cost $ 10 to $ 12.
*** Abbott Laboratories 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.
~~~ later we discuss the Sanofi patents and how they relate to HIV-1 and HIV-2 POCTesting |
