Post Marketing Surveillance of Oraquick Rapid HIV Testing Laura Wesolowski, PhD Gale R Burstein, MD, MPH Julia Zhu, MS Steven Ethridge, MT Division of.

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Presentation transcript:

Post Marketing Surveillance of Oraquick Rapid HIV Testing Laura Wesolowski, PhD Gale R Burstein, MD, MPH Julia Zhu, MS Steven Ethridge, MT Division of HIV/AIDS Prevention Centers for Disease Control and Prevention February 28, 2005

Presentation Objectives Background Post Marketing Surveillance PMS-1 Findings PMS-2 Status Update

Background January 2003, OraQuick 1 st HIV antibody test to receive a CLIA waiver To increase use of CLIA-waived rapid HIV tests, CDC purchased and distributed: ,500 devices ,050 devices ,000 devices Devices distributed to over 211 organizations

Post Marketing Surveillance July 2003, CDC initiated Post Marketing Surveillance (PMS-1) to monitor implementation of CLIA-waived rapid HIV testing with OraQuick

Objectives Measure rapid HIV test utilization and outcomes Evaluate discordant test results Characterize quality assurance methods and outcomes

Post Marketing Surveillance Phases PMS-1 (July to December 2003) 14 Health Departments identified sites to participate 12 State (AZ, CA, CO, FL, IN, LA, MA, MD, MI, NY, UT, WI) 2 City (Chicago, SF) 6 health departments submitted 2002 historical counseling and testing data PMS-2 (July 2004 to June 2005) 18 Health Departments identified sites to participate 15 State (AZ, DE, FL, IN, LA, MA, MD, MI, MT, NE, NC, NJ, NY, UT, WI) 3 City (Chicago, NYC, SF)

Examples of Sites Offering Rapid HIV Test STD clinics C&T sites Correctional facilities Drug treatment programs Mobile vans serving high-risk communities CBOs Hospitals Youth health clinics Homeless shelters Other outreach settings

Results : Total HIV Tests in PMS-1 Sites in 12 Project Areas, 2003 Total = 30,184 Rapid = 20,319 EIA = 9,865 Confirmed Positives = 533 (1.8%) Rapid = 378 (1.9%) EIA = 155 (1.6%)

Results: HIV Tests in PMS-1 Sites in 6 Project Areas, 2002 vs 2003* 14,352 total tests 159 (1.1%) confirmed positive tests 14,898 total tests 9410 (63%) rapid 5488 (37%) EIA 181 (1.2%) confirmed positive tests 107 (1.1%) rapid 74 (1.3%) EIA *Measured during comparable time periods

# rapid tests #EIAs Results: Number of HIV Tests in PMS-1 Sites in 6 Project Areas, 2002 vs 2003* ColoradoMarylandMichiganNew YorkUtahWisconsin *Measured during comparable time periods

Results: Number of Positive HIV Tests in PMS-1 Sites in 6 Project Areas, 2002 vs 2003* ColoradoMarylandMichiganNew YorkUtahWisconsin # confirmed positive rapid tests# confirmed positive EIAs *Measured during comparable time periods

Results: % of Test Results Received by Client by Test Result and Test Type in 4 PMS-1 Project Areas 2002 vs 2003* Negative Test Results Positive Test Results * Measured during comparable time periods ** % based on the number of HIV+ clients who received their preliminary positive rapid test results

Results: PMS-1 HIV Discordant Tests MMWR 2004:53; * Enzyme immunoassay** Positive § Negative Western blot¶¶ Indeterminate ¶ Immunoflourescent assay Not done §§ Not performed until after surveillance follow-up was initiated

Discordant Follow-up Preliminary positive rapid tests should be confirmed with Western blot or IFA, even if EIA non-reactive. If this confirmatory testing yields negative or indeterminate results, test on blood specimen 4 weeks after preliminary positive rapid.

PMS-II Update PMS-2 Objectives Data Collection Database created used in 2 project areas Data translation tables completed for 17 project areas To date, data submitted from 13 project areas SAS-based data quality check program completed File structure, out-of-range values, missing values, logic Data check reports sent to project areas

PMS-II Discordant Tests Discordant Protocol Case definition Case report form Discordant results database created Specimens sent to CDC for: EIA and Western blot testing Viral RNA Rheumatoid factor Epstein Barr virus serologies Hepatitis A, B and C serologies

PMS-II Discordant Tests 26 discordants since August 2004 from 8 project areas 4 True Positives 5 False Positives 3 Indeterminates 14 Pending

PMS-II Quality Assurance Objectives Assess incidence of invalid tests Evaluate frequency of external control runs and invalid controls Assess frequency of out-of-range temperatures in testing area and control and test kit storage areas Characterize QA policies and procedures Rapid test coordinator survey

Additional Information CDC Rapid HIV Test website: Contains: QA Guidelines for Testing Using the OraQuick Rapid HIV-1 Antibody Test Laboratory Considerations and Package Inserts HIV Counseling with Rapid Tests