APHL Survey HIV Diagnostic Testing Utilization Barbara G. Werner, Ph. D MA State Laboratory Institute February 28, 2005
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”
Survey Format and Launch • Electronic Survey on APHL Lab. Net • 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
Survey Respondents • 49 Responses; overall 88% – 48 States, one territory • 7 No response
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
HIV Screening Tests Utilized (%)* bio. Merieux Vironostika HIV-1 bio. Merieux Viron HIV-1 PLUS O Bio-Rad Gen Sys HIV-1 r. LAV Bio-Rad HIV 1/2 Synthetic Peptide Bio-Rad HIV-1/HIV-2 PLUS O Abbott HIVAB HIV-1/2 Genetic Systems HIV-2 EIA bio. Merieux Oral Viron HIV-1 63 0 20 10 10 20 18 61 *Percent of responding labs reporting use within past year
EIAs Used for 1 o Screening of Sera • • bio. Merieux Vironostika HIV-1 Bio-Rad Gen. Sys. r. LAV Abbott HIV-1/2 Bio-Rad HIV 1/HIV 2 Plus O 30 labs* 8 7** 4 * 2 labs used in tandem --with Genetic Systems r. LAV or Bio-Rad HIV-1/2 Synthetic Peptide ** Used as backup in one other state Genetic Systems HIV-2 EIA Not necessarily for initial screen 9 labs
Changes in Use of Screening Tests • 11 indicated that they plan to change to another EIA within next year • Decisions pending validation
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
Testing Oral Fluid Specimens • 30 labs used Oral Vironostika HIV-1 • 28 labs used Orasure HIV-1 WB assay
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
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
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
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
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
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
Acknowledgments • Anthony Tran, APHL Staff • APHL/CDC HIV Steering Committee • APHL Members
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