Transcript Post-Marketing Surveillance for the OraQuick Rapid HIV

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 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
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
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STD clinics
C&T sites
Correctional facilities
Drug treatment
programs
• Mobile vans serving
high-risk communities
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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*
2002
2003
• 14,352 total tests
• 14,898 total tests
• 9410 (63%) rapid
• 5488 (37%) EIA
• 159 (1.1%) confirmed
positive tests
• 181 (1.2%) confirmed
positive tests
• 107 (1.1%) rapid
• 74 (1.3%) EIA
*Measured during comparable time periods
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
Colorado
2002 2003
Maryland
2002 2003
Michigan
# rapid tests
*Measured during comparable time periods
2002 2003
New York
#EIAs
2002 2003
Utah
2002 2003
Wisconsin
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
Colorado
Maryland
Michigan
New York
# confirmed positive rapid tests
*Measured during comparable time periods
2002 2003
Utah
2002 2003
Wisconsin
# confirmed positive EIAs
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
100
90
80
70
60
50
40
30
20
10
0
Positive Test Results
100
90
80
70
60
50
40
30
20
10
0
MI
NY
EIA (2002)
UT
WI
Rapid Test (2003)
MI
NY
UT
EIA/WB or IFA (2002)
Rapid Test (2003)**
* Measured during comparable time periods
** % based on the number of HIV+ clients who received their preliminary positive
rapid test results
WI
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
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:
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