1. Implementing Rapid HIV Testing: Technologies, Legal and Cost Issues Vanessa Lee, MPH HIV Rapid Testing Coordinator CA Office of AIDS

2. 2 Overview Background FDA-approved Rapid Tests Legal Issues Cost Issues Rapid Testing Resources

3. 3 Why do rapid HIV testing? Accurate & simple Deliver results to everyone Convenient for patients

4. 4 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

5. FDA-approved Rapid HIV Tests Factors to consider

6. 6 FDA-approved Rapid Tests Reveal (MedMira) OraQuick (OraSure Technologies) Uni-Gold (Trinity Biotech) Multispot (Bio-Rad) All test for HIV antibodies

7. 7 Reveal G-2 HIV-1 Test Serum & Plasma

8. 8 Reveal G2 Pros: Fastest processing time Cons: Somewhat complicated Lower specificity Serum or plasma only - requires centrifuge equipment Requires operator attention during entire process

9. 9 OraQuick Advance Oral Fluid Whole blood Plasma

10. 10 OraQuick Pros: Simplest procedure Flexible read time Tests for HIV-2, oral fluid Internal control verifies addition of sample Cons: Longest [passive] processing time

11. 11 Uni-Gold Whole blood Plasma & Serum

12. 12 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)

13. 13 Multispot HIV-1/2 Serum Plasma

14. 14 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

15. 15 A net with very high sensitivity would not miss (m)any tuna Sensitivity

16. 16 A net with very high specificity would not catch many dolphins Specificity

17. 17 TestSensitivity 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%

18. 18 Positive Predictive Value PPV is the likelihood that a positive result is a true positive. Another way to say it: What is the chance that this person who just tested positive, is actually positive?

19. 19 S/S & PPV Sensitivity is the probability that: Test = positive if patient = positive PPV is the probability that: Patient = positive if test = positive To confuse matters even more, it is actually a combination of prevalence and specificity (not sensitivity) that determines a tests positive predictive value.

20. 20 99.9% x 1000 = 999 correct negative results 1 False Positive Test 1000 people… Specificity of 99.9% 5% Positivity rate = 5% 5% x 1000 = 50 50 True positives 1 False positive 51 Total positives 50/51 = 98% ppv.1% Positivity rate =.1%.1% x 1000 = 1 1 True positive 1 False positive 2 Total positives 1/2 = 50% ppv Positive Predictive Value

21. 21 Risk Group Positivity Rate PPV HIV+ Partner 4.4% 97.9% General Pop 0.4% 80.1% IDU 1.2% 92.4% MSM + IDU 5.4% 98.3% MSM 4.3% 97.8% MSMW 3.0% 96.9% Positive Predictive Value Positivity rate of 1% results in PPV of greater than 90%

22. 22 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.

23. Legal issues Implementation requirements

24. 24 Implementation requirements CLIA certification (Federal law) HIV approval (California law) Personnel requirements (California law)

25. 25 CLIA certification Clinical Laboratory Improvement Amendment (CLIA) To perform CLIA-waived tests, entities must: 1)Enroll in CLIA program 2)Obtain a Certificate of Waiver 3)Pay a biennial fee 4)Follow manufacturers instructions 5)Meet state requirements

26. 26 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.

27. 27 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.

28. Cost Issues Billing and reimbursement

29. 29 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

30. 30 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.

31. Thank you!!