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Implementing Rapid HIV Testing:Technologies, Legal and Cost Issues
Vanessa Lee, MPHHIV Rapid Testing Coordinator
CA Office of AIDS
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Overview
Background FDA-approved Rapid Tests Legal Issues Cost Issues Rapid Testing Resources
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Why do rapid HIV testing?
Accurate & simple Deliver results to everyone Convenient for patients
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Office of AIDS & Rapid Testing
Settings: Clinics, CBOs, Mobile units, outreach venues, jails
Populations: targeted high-risk Conclusions:
Clients like itPersonnel adapt quicklyEfficient use of resourcesQA elements important
FDA-approved Rapid HIV Tests
Factors to consider
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FDA-approved Rapid Tests
Reveal (MedMira) OraQuick (OraSure Technologies) Uni-Gold (Trinity Biotech) Multispot (Bio-Rad)
All test for HIV antibodies
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Reveal G-2 HIV-1 Test
Serum & Plasma
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Reveal G2
Pros:Fastest processing time
Cons:Somewhat complicatedLower specificitySerum or plasma only - requires
centrifuge equipmentRequires operator attention during
entire process
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OraQuick Advance
Oral Fluid Whole blood Plasma
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OraQuick
Pros:Simplest procedureFlexible read timeTests for HIV-2, oral fluidInternal control verifies addition of
sample Cons:
Longest [passive] processing time
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Uni-Gold
Whole blood Plasma & Serum
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UniGold
Pros:Relatively simple procedure10 minute processing time
Cons:No flexibility in read timeInternal control does not verify
addition of sample (03.04 PI)
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Multispot HIV-1/2
Serum Plasma
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Multispot
Pros-can distinguish between HIV-1 and 2
-approx. 10 minutes to complete process
-can read results immediately or up to 24 hours after completion
Cons
-more difficult processing steps-once test process started, must complete
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A net with very high sensitivity would not “miss” (m)any tuna
SensitivitySensitivity
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A net with very high specificity would not “catch” many dolphins
SpecificitySpecificity
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Test Sensitivity
Sensitivity & Specificity
Specificity
Uni-Gold 100% 99.7% - 99.8%
OraQuick 99.6% 99.9% - 100%
Reveal 99.8% 98.6% – 99.1%Multispot 100% 99.9%
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Confirmatory Protocols
Negative results considered conclusive (outside of window period)
Preliminary positive results must be confirmed!Oral Fluid or Blood
Lab must be informed of preliminary positive.All preliminary positives must be
confirmed by WB or IFA – even if EIA is negative.
Legal issues
Implementation requirements
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Implementation requirements
CLIA certification (Federal law) HIV approval (California law) Personnel requirements (California law)
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CLIA certification
Clinical Laboratory Improvement Amendment (CLIA)
To perform CLIA-waived tests, entities must:
1)Enroll in CLIA program2)Obtain a Certificate of Waiver3)Pay a biennial fee4)Follow manufacturers’ instructions5)Meet state requirements
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HIV approval
17 California Code of Regulations 1230 (17 CCR 1230)
Requires any entity conducting HIV testing to have a California laboratory license and be enrolled in a DHS-approved proficiency testing program.
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Personnel Requirements
California Business and Professions Code 1206.5 (BPC 1206.5)
Delineates personnel requirements for operating CLIA-categorized laboratory tests, including CLIA-waived tests.
Cost Issues
Billing and reimbursement
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Cost Issues for Non-OA Programs
Action Plan: explore how HIV testing is currently reimbursed in your site(s)
Sources mentioned by hospitals and family planning clinics include:
-private insurance
-Medi-Cal
-Family PACT
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Rapid HIV Testing Resources
CDC website Laboratory personnel (local and state) Office of AIDS guidance and protocols Test kit manufacturers
Handout includes links and contact information for resources above.
Thank you!!