OraQuick Should be Approved for Use Outside of Laboratories, Editorial Says
OraQuick, a rapid HIV test created by Bethlehem, Pa.-based OraSure Technologies, should be approved by the FDA for use outside of laboratories so the test can be used on low-income populations and in "nontraditional" settings, Arleen Leibowitz, a professor at UCLA School of Public Policy and Social Research and a member of the UCLA Center for HIV Identification, Prevention and Treatment Services; Stephanie Taylor, a CHIPTS fellow; and Jonathan Fielding, a Los Angeles County health officer and UCLA professor in pediatrics, write in a Los Angeles Times editorial. Last month's FDA approval of the test, which requires only a drop of blood and takes 20 minutes to provide results instead of the two to 14 days required for standard HIV tests, represents a "major victory in the battle against HIV/AIDS", the editorial says. However, the FDA requirement that the test be conducted only in "certified laboratories" excludes use of the test in mobile vans, county jails and other sites that reach transient, low-income and uninsured people, the editorial contends. According to the editorial, 25% of those who were tested in mobile medical vans did not return to receive their results, but the "percentage of clients receiving results would be greatly increased if it were possible to use the OraQuick tests to provide results on the spot." The test is "remarkably reliable, with very small percentages of false negative or false positive results" and is "no more difficult to use than at-home glucose tests for diabetics," the editorial continues. The editorial concludes, "The FDA should approve the manufacturer's application to waive restrictions limiting the use of the OraQuick rapid test to laboratories" because it is "essential that people with HIV learn their status early so they can receive drugs to delay the onset of AIDS" (Leibowitz et. al., Los Angeles Times, 12/3).
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