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