increasing our reach through rapid hiv testing
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Increasing Our Reachthrough Rapid HIV Testing
Bernard M. Branson, M.D.Chief, Lab Determinants and Diagnostics
SectionCenters for Disease Control and Prevention
040,000 0 2,000,000
1,442,847 786,9371,147,25126,46522,5141997 1,147,25122,5149,843
27,947 1,374,7091996 708,2201,442,84726,4658,023
What if rapid HIV tests wereused in all public testing sites?
Additional, Rapid Test
HIV PositiveStandard testing
HIV Negative
Additional, Rapid Test
Standard testing
1998 1,442,847 856,8761,147,25126,46522,514 1,091,04518,1189,843
1,442,847 903,8391,147,25126,46522,514 995,95216,04811,1921999
1,442,847 913,0571,147,25126,46522,514 1,028,27416,22310,5932000
OraQuick: Oral fluid, serum, whole blood
FDA-approved November 7, 2002 for use with fingerstick whole
blood specimens
Obtain fingerstick blood specimen
Similar loop is used with several rapid tests
Insert loop into vial and stir
Test develops in 20 minutes
Positive Negative
Reactive Control
Positive HIV-1/2
Read results
Oral fluid specimens reduce hazards, facilitate testing in field settings
Rapid Test Performance: Serum
Sensitivity Specificity
OraQuick 100% 100%
SUDS 97.9% 94.5%
HIV 1- 2 EIA - 95.1%
206 HIV+, 194 HIV- stored sera
Rapid Test Performance: Prospective Study
False Negative
Sensitivity
False Positive
Specificity
OraQuick 0/73 100% 2/1639 99.9% OraQuick Oral 0/72 100% 18/1569 98.9% SUDS 1/72 98.6% 6/1641 99.6%
1649 Clients at Testing Site /STD Clinics
CDC experiences with rapid HIV testing outside the US
HIV Testing in Kenya is Done on Site by a Trained Counselor, Supervised by a
Laboratory Technician
Two different, rapid, simple whole blood tests are used for every client
Confirmed results in 15 to 20 minutes
Tests used at present: Abbott Determine Trinity Biotech UniGold
Increase in Demand for VCT in Malawi with Same Day Results using Rapid
Tests
230 272 245420
542
8411103
1633 1602
1922
Jan Feb March April May
1999 (1-2 week wait) 2000 (same day results)
VCT Clients in Malawi: Waiting period versus same day results
0
5000
10000
15000
20000
25000
30000
35000
40000
45000
92 93 94 95 96 97 98 99 2000 2001
Waiting period Same day results
Rapid Increase in Utilization of VCT in Kibera, March 2001 – March 2002
0
200
400
600
800
1000
1200
1400
Female Male
• KICOSHEP served 12,157 VCT clients at 5 sites in the Kibera slum and at 17 medical camps
Outcomes with rapid HIV testing in the U.S.
Cook County Jail (CCJ) Female Intake
Largest single-site jail in the U.S. 100,000 detainees each year 15% females:
80+ females through intake area daily 50% released in < 36 hours
Study period: October 2000 – May 2001
Cook County Hospital Emergency Department
(CCH-ED)
Busiest emergency department in Chicago 120,000+ patient visits per year January 2001 conventional HIV testing Study period: June 2001 – February 2002
Eligibility and Acceptance
CCJ Intake
# Approach 3055
# Eligible 2289 (75%)
# Accept RT 988 (43%)
CCH -ED
7072
6038 (85%)
1652 (27%)
CCJ Intake
CCH ED
# rapid tested 988 1652
# received results 985 (99.7%) 1640 (99.3%)
# new HIV+ 9 (0.9%) 46 (2.8%)
# entered care 2 (22%) median 50 days
36 (80%) median 13 days
Rapid Test Outcomes
CCJ N=9
CCH N=46
No previous test 4 (44%) 26 (57%)
Risk Factors
MSM 0 14 (30%) IDU 1 (11%) 6 (13%) Sex Partner IDU 0 3 ( 7%) Sex Partner HIV+ 0 3 ( 7%) No identified risk 2 (22%) 22 (48%)
CharacteristicsRapid Test Positive Patients
CCJ – Female Intake None of RT patients came
to Screening Clinic for CT results
Difficulties in patient follow-up
CCH – ED Many HIV+ patients without
risk factors Second phlebotomy not a
deterrent Many patients had no
additional blood drawn Little need for psych support
Surprises
HIV Screening in Acute Care Settings
Cook County ED, Chicago 2.8% Grady ED, Atlanta 2.7% Johns Hopkins ED, Baltimore 3.2%
New HIV+
Perinatal Screening: MIRIAD Study
Testing of pregnant women in labor for whom no HIV test results are available; 12 hospitals in 5 cities: Atlanta, Chicago, Miami, New Orleans, New York
To date 1771 women screened 12 new HIV infections identified No false positives, no false negatives
Bethany HospitalBethany Hospital
Rapid test performed on Labor and Delivery unit.
Eligible patients are determined here in the Labor and Delivery Triage area.
The rapid test is done on this counter, extra supplies are stored below.
OB physicians and Midwives share MIRIAD testing at Provident.
Provident HospitalProvident Hospital
Cook County HospitalCook County Hospital
Clerks on each shift access HIV results from the computer system.
Eligible patients are offered rapid testing and consented in the Triage area.
Boxplot of Turn Around Times
060
120180240300360420480540600660720780840900960
Bethany CCH Provident St. Bernard
Reasons for Delay in Reasons for Delay in Delivering Rapid Test Delivering Rapid Test
ResultsResults
Out of sight out of mind (when sent to lab) Shift change Patient sleeping Getting blood to the laboratory and getting
result back
OraQuick Outreach to High Risk Persons of Color
Patrick Keenan MDUniversity of Minnesota Medical
SchoolDepartment of Family Practice and
Community Health
OraQuick Research Study (7/22/02) N = 115
On-site group pretest counseling. Individual testing and post-test
counseling. Testing procedure:
Oral fluid OraQuick (research only) Fingerstick OraQuick (results given) Fingerstick neg -> OraSure backup Fingerstick pos -> venous EIA/WB
Client Survey Results I
“I have tested for HIV in the past and I prefer receiving my results the same day”
Strongly agree or agree = 97%Disagree or strongly disagree = 3%
Client Survey Results II
“It would have been better to wait a week before getting any results”
Agree or strongly agree = 3%Disagree or strongly
disagree = 97%
Client Survey Results III
“I found the rapid testing stressful”
Agree or strongly agree = 33%Disagree or strongly
disagree = 67%
Client Survey Results IV
“I would rather have my finger stuck than have blood drawn from my vein”
Agree or strongly agree = 88% Disagree or strongly disagree = 7% No difference = 5%
Client Survey Results V
“I would recommend rapid testing to a friend”
Agree or strongly agree = 94% Disagree or strongly disagree = 6%
Client Survey Results: VI
“I understand the results of my test.”
Agree or strongly agree = 99% Disagree or strongly disagree = 1%
GAY & GAY & LESBIAN LESBIAN CENTERCENTER
GAY & GAY & LESBIAN LESBIAN CENTERCENTER
STD STD CLINICCLINIC
STD STD CLINICCLINIC
13
1
3
2625%
1.1%* 0.4%*
98.5%*
*Percentage of correct results obtained, does not include 13 “invalid” test results.
Correct
Invalid
False Negative
False Positive
Untrained Users 1– 279 Patient specimens
74
12
13
565
Untrained Users – 664 Evaluation panel specimens
11%
2.2%*
2.0%*
95.8%*
*Percentage of correct results obtained, does not include 74 “invalid” test results.
Correct
Invalid
False Negative False
Positive
Lessons Learned
Client Acceptance Levels
Testing & Counseling Unit
Logistics
Personnel Issues
Confirmatory Testing
For Western blot: Venipuncture for whole blood Oral fluid specimen Dried blood spots on filter paper
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