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Performance is regulated by the Clinical Laboratory Improvement Amendment of 1988 (CLIA). The tests are categorized as CLIA "waived" or "moderate complexity." OraQuick, Clearview and Uni-Gold are CLIA waived tests, which means there are no federal restrictions for personnel, quality assessment or proficiency testing. The tests can be performed in laboratories, clinical settings, mobile vans, physicians’ offices, etc. The requirement is to obtain a certificate of waiver and follow manufacturer's instructions (see www.cdc.gov/hiv/topics/testing/rapid/rt-purchasing.htm). Reveal , VITROS Anti-HIV 1 & 2 and Multispot HIV-1/HIV-2 are "moderately complex," which requires registering with CLIA, and satisfying CLIA standards for personnel, quality assessment, proficiency testing and inspections. The retail cost is $15- 25/test or $8-9 for CDC funded expanded access sites, but the cost to a consumer may be much more. Reveal , VITROS and Multispot require plasma or serum, and thus a centrifuge. Common features for all of these tests:
- Persons tested receive a "Subject Information Notice" provided with the test.
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TABLE 2-2: