1. APHL Survey HIV Diagnostic Testing Utilization Barbara G. Werner, PhD MA State Laboratory Institute February 28, 2005

2. Information about Current Testing Status to Address New Challenges New EIA screening tests Expanded use of rapid tests Additional uses of nucleic acid amplification tests (NAAT) Confirmatory testing in different settings –The old 9 letter word “algorithm”

3. Survey Format and Launch Electronic Survey on APHL LabNet Content and design input from APHL/CDC HIV Steering Committee Timeframe: July/August 2004 Sent to 56 Jurisdictions –PH labs in all states, DC and 5 territories –Limitation: Local/county PH labs not included

4. Survey Respondents 49 Responses; overall 88% –48 States, one territory 7 No response

5. Questions about HIV Testing EIA and Confirmatory Testing Use of NAAT Acute infection testing Incidence surveillance testing Rapid HIV Testing CLIA Limited Public Health Use Exception

6. HIV Screening Tests Utilized (%)* bioMerieux Vironostika HIV-1 63 bioMerieux Viron HIV-1 PLUS O 0 Bio-Rad Gen Sys HIV-1 rLAV 20 Bio-Rad HIV 1/2 Synthetic Peptide 10 Bio-Rad HIV-1/HIV-2 PLUS O 10 Abbott HIVAB HIV-1/2 20 Genetic Systems HIV-2 EIA 18 bioMerieux Oral Viron HIV-1 61 * Percent of responding labs reporting use within past year

7. EIAs Used for 1 o Screening of Sera bioMerieux Vironostika HIV-1 30 labs* Bio-Rad Gen. Sys. rLAV 8 Abbott HIV-1/2 7** Bio-Rad HIV1/HIV2 Plus O 4 * 2 labs used in tandem --with Genetic Systems rLAV or Bio-Rad HIV-1/2 Synthetic Peptide ** Used as backup in one other state Genetic Systems HIV-2 EIA 9 labs Not necessarily for initial screen

8. Changes in Use of Screening Tests 11 indicated that they plan to change to another EIA within next year Decisions pending validation

9. Confirmatory Tests Used by Labs for Serum/Plasma 34 Bio-Rad Gen Sys HIV-1 Western blot 11 Calypte Camb Biotech HIV–1 WB 7 Fluorgnost HIV-1 IFA –4 in conjunction with Western blot for serum Only three states planned to switch confirmatory test within year

10. Testing Oral Fluid Specimens 30 labs used Oral Vironostika HIV-1 28 labs used Orasure HIV-1 WB assay

11. Nucleic Acid Amplification Testing 25 labs reported capability 14 labs currently performing NAAT –11 for patient monitoring –3 for acute infection screening 2 additional states indicated interest in initiating NAAT for acute infection screening within the next year

12. Seroincidence Testing At time of survey, 10 states performed incidence testing, as part of CDC or local surveillance efforts Note: IND for incidence testing using Vironostika EIA to be terminated by CDC

13. Involvement with HIV Rapid Testing Approximately one-half reported delivering at least one training course (CDC or own) and 2 additional labs had developed course but had not implemented With limited follow-up, some labs were involved with confirmatory testing, some with QA responsibilities

14. CLIA Limited PH Use Exception Six states reported use of the Exception, allowing multiple labs to operate under a single CLIA certificate 4 of 6 permit CBOs, etc. to use for HIV rapid testing –On follow up, all 4 provide confirmatory testing and oversight

15. Conclusions and Challenges Communication issues –Knowledge of changing assays, incidence testing, etc Confirmation of new tests with Group O antigens, as well as HIV-2, is an issue as is limited choice for confirmatory tests Integration of rapid tests –Confirmatory testing –Educational assistance for QA Likelihood of new or different algorithms in different settings

16. Efforts to Improve Communication APHL/CDC HIV Steering Committee APHL Updates for Members –Electronic and print, including Survey Report for HIV Testing Utilization APHL ID Committee –Interim Position Statement on Rapid Tests Presentations/Roundtables –APHL/ASTHO Annual Meetings –HIV Diagnostics Conference –HIV Prevention Conference

17. Acknowledgments Anthony Tran, APHL Staff APHL/CDC HIV Steering Committee APHL Members