Implementing Rapid HIV Testing:Technologies, Legal and Cost Issues Vanessa Lee, MPH HIV Rapid Testing Coordinator CA Office of AIDS
Overview • Background • FDA-approved Rapid Tests • Legal Issues • Cost Issues • Rapid Testing Resources
Why do rapid HIV testing? • Accurate & simple • Deliver results to everyone • Convenient for patients
Office of AIDS & Rapid Testing • Settings: Clinics, CBOs, Mobile units, outreach venues, jails • Populations: targeted high-risk • Conclusions: • Clients like it • Personnel adapt quickly • Efficient use of resources • QA elements important
FDA-approved Rapid HIV Tests Factors to consider
FDA-approved Rapid Tests • Reveal (MedMira) • OraQuick (OraSure Technologies) • Uni-Gold (Trinity Biotech) • Multispot (Bio-Rad) All test for HIV antibodies
Reveal G-2 HIV-1 Test • Serum & Plasma
Reveal G2 • Pros: • Fastest processing time • Cons: • Somewhat complicated • Lower specificity • Serum or plasma only - requires centrifuge equipment • Requires operator attention during entire process
OraQuick Advance • Oral Fluid • Whole blood • Plasma
OraQuick • Pros: • Simplest procedure • Flexible read time • Tests for HIV-2, oral fluid • Internal control verifies addition of sample • Cons: • Longest [passive] processing time
Uni-Gold • Whole blood • Plasma & Serum
UniGold • Pros: • Relatively simple procedure • 10 minute processing time • Cons: • No flexibility in read time • Internal control does not verify addition of sample (03.04 PI)
Multispot HIV-1/2 • Serum • Plasma
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
Sensitivity A net with very high sensitivitywould not “miss” (m)any tuna
Specificity A net with very high specificitywould not “catch” many dolphins
OraQuick 99.6% 99.9% - 100% Uni-Gold 100% 99.7% - 99.8% Reveal Multispot 99.8% 100% 98.6% – 99.1% 99.9% Sensitivity & Specificity Test Sensitivity Specificity
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
Implementation requirements • CLIA certification (Federal law) • HIV approval (California law) • Personnel requirements (California law)
CLIA certification • Clinical Laboratory Improvement Amendment (CLIA) • To perform CLIA-waived tests, entities must: • Enroll in CLIA program • Obtain a Certificate of Waiver • Pay a biennial fee • Follow manufacturers’ instructions • Meet state requirements
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.
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
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
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.