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Post Marketing Surveillance of Oraquick Rapid HIV Testing

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. Background Post Marketing Surveillance PMS-1 Findings

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Post Marketing Surveillance of Oraquick Rapid HIV Testing

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  1. 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

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

  3. Background • January 2003, OraQuick 1st HIV antibody test to receive a CLIA waiver • To increase use of CLIA-waived rapid HIV tests, CDC purchased and distributed: • 2003- 219,500 devices • 2004- 327,050 devices • 2005- 200,000 devices • Devices distributed to over 211 organizations

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

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

  6. 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)

  7. 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 Examples of Sites Offering Rapid HIV Test

  8. 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%)

  9. 14,352total 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 Results: HIV Tests in PMS-1 Sites in 6 Project Areas, 2002 vs 2003* 20022003 *Measured during comparable time periods

  10. Results: Number of HIV Tests in PMS-1 Sites in 6 Project Areas, 2002 vs 2003* 6000 5000 4000 3000 2000 1000 0 2002 2003 2002 2003 2002 2003 2002 2003 2002 2003 2002 2003 Colorado Maryland Michigan New York Utah Wisconsin # rapid tests #EIAs *Measured during comparable time periods

  11. Results: Number of Positive HIV Tests in PMS-1 Sites in 6 Project Areas, 2002 vs 2003* 60 50 40 30 20 10 0 2002 2003 2002 2003 2002 2003 2002 2003 2002 2003 2002 2003 Colorado Maryland Michigan New York Utah Wisconsin # confirmed positive rapid tests # confirmed positive EIAs *Measured during comparable time periods

  12. 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

  13. Results: PMS-1 HIV Discordant Tests MMWR 2004:53;221-222 * Enzyme immunoassay ** Positive § Negative ††Western blot ¶¶ Indeterminate ¶ Immunoflourescent assay † Not done §§ Not performed until after surveillance follow-up was initiated

  14. 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.

  15. 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

  16. 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

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

  18. 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

  19. Additional Information CDC Rapid HIV Test website: www.cdc.gov/hiv/rapid_testing/ • Contains: • QA Guidelines for Testing Using the OraQuick Rapid HIV-1 Antibody Test • Laboratory Considerations and Package Inserts • HIV Counseling with Rapid Tests

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