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APHL SurveyHIV Diagnostic Testing Utilization
Barbara G. Werner, PhD
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 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
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 (%)*
bioMerieux Vironostika HIV-1 63bioMerieux Viron HIV-1 PLUS O 0Bio-Rad Gen Sys HIV-1 rLAV 20Bio-Rad HIV 1/2 Synthetic Peptide 10 Bio-Rad HIV-1/HIV-2 PLUS O 10Abbott HIVAB HIV-1/2 20Genetic Systems HIV-2 EIA 18bioMerieux Oral Viron HIV-1 61
*Percent of responding labs reporting use within past year
EIAs Used for 1o 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 labsNot necessarily for initial screen
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 Labsfor 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