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CDC HomeHIV/AIDS > Topics > Testing > Rapid HIV Testing > CDC Studies of Rapid HIV Testing

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CLIA-Waived vs. Moderately Complex Rapid HIV Testing:  How Much Will It Cost?
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Sykes DL1, Branson BM2, Truax SR1
1Office of AIDS, California Dept. of Health Services, Sacramento, CA; 2Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA

Background.  Rapid HIV tests are useful in both clinic and outreach settings because more persons learn their results. Some newer rapid tests are simple, accurate, do not require special laboratory equipment and can be performed in ≤15 minutes. The Clinical Laboratory Improvement Act (CLIA), could categorize these diagnostic tests as moderately complex or as waived. The two categories require different personnel.

Objective. Estimate the costs for California’s HIV testing program if simple, rapid HIV tests are categorized as waived versus moderately complex.

Methods.  We calculated personnel costs for rapid HIV testing under the two CLIA categories. Based on specific qualifications required and the state’s personnel classification system, hourly wages to perform rapid tests would be $9 if waived and $17 if moderately complex. Counseling times were derived from the counseling and testing database. We estimated that rapid tests would require 15 minutes to perform.

Results.  Of approximately 200,000 annual HIV tests, 1% are positive. Risk assessment (pretest counseling) requires 20 minutes. Disclosure sessions (posttest counseling) average 15 minutes for HIV-negative persons and 45 minutes for HIV-positive. Annually, a total of 117,667 hours are required for counseling, and approximately 51,000 hours for rapid testing. If the counselor also performs the test, waived HIV testing would cost California $1,518,000 per year, and moderately complex, $2,867,339 ($1.35 million more.) If a person other than the counselor performs the test, additional personnel costs would exceed $408,000 annually if rapid tests were categorized as moderately complex, assuming these persons actually spent all hours performing tests.

Conclusion. Rapid HIV testing will cost substantially more with moderately complex than with waiver categorization under CLIA.

Implications for Programs/Policy:  Waived rapid tests will be most cost-effective, but subject to less formal oversight. Therefore, programs need to develop systems to guarantee quality and proficiency.

Presented at 2002 National STD Prevention Conference, March 4-7, 2002, San Diego, CA.

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Last Modified: September 12, 2006
Last Reviewed: September 12, 2006
Content Source:
Divisions of HIV/AIDS Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
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