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

3. 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: 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. 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

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. 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 2002 2003 *Measured during comparable time periods

10. # rapid tests #EIAs Results: Number of HIV Tests in PMS-1 Sites in 6 Project Areas, 2002 vs 2003* 0 1000 2000 3000 4000 5000 6000 ColoradoMarylandMichiganNew YorkUtahWisconsin 200220032002200320022003200220032002200320022003 *Measured during comparable time periods

11. Results: Number of Positive HIV Tests in PMS-1 Sites in 6 Project Areas, 2002 vs 2003* 0 10 20 30 40 50 60 ColoradoMarylandMichiganNew YorkUtahWisconsin # confirmed positive rapid tests# confirmed positive EIAs 2002 20032002 20032002 20032002 20032002 20032002 2003 *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