1. TUPEB018 Field evaluation of rapid HIV serologic tests for screening HIV-1/2 infection using serum samples from Rakai Cohort, Uganda.
S.C. Kagulire, P.D. Stamper, P.Opendi, J.L. Nakavuma, L.A. Mills, F.Makumbi, R.H.Gray, D.Serwadda, and S.J.Reynolds

2. BACKGROUND
HIV/AIDS is still highly prevalent in much of Sub-Saharan Africa
HIV testing and counseling is a major component of Intervention Programs advocating prevention and Management of HIV/AIDS
Several good HIV rapid detection/testing tools have been developed
Few of these tests have received adequate “head to head” evaluation in resource constrained regions.

3. BACKGROUND……
Sensitivity and Specificity Data could guide to product selection in resource constrained countries where HIV prevention and treatment programs are very dependent on these assays.
Many parameters must be carefully considered when determining criteria for product selection.

4. OBJECTIVE
To evaluate the performance of 5 simple, HIV rapid diagnostic tests on serum samples in a field setting.

5. STUDY DESIGN
Single- phase evaluation of simple HIV rapid diagnostic assays using prospectively collected blood specimens from Rakai cohort participants

6. MATERIALS & METHODS
150 fresh blood specimens were collected in an on-going survey in the Rakai Cohort (May 2005)
Staff blinded to testing status: 100 unknown HIV results, 50 positive samples to supplement to obtain necessary precision
Consented respondents aged 15-49
Serum samples were tested for HIV-1/2 antibodies using the five different rapid tests

7. MATERIALS & METHODS Assays used
Determine (Abbott Laboratories-Germany)
Unigold (Trinity Biotech- Ireland)
Statpak ( Chembio Diagnostic Systems, Inc- USA)
Advanced Quality ( InTec Product, Inc –China)
First Response (PMC Medical-India)
EIA 1 (Abbott Murex, Murex Biotech Ltd, UK)
EIA 2 (Vironostika HIV Uni-form II Micro ELISA, bioMerieux, Switzerland)
WB (Calypte Biomedical Corporation, USA)

8. MATERIALS & METHODS… Specifications of HIV tests
Assay name
No. of kit
HIV type
Sample type
Cost / test, USD
Determine
100
HIV 1/ 2
BSP
1.2
Unigold 20
HIV 1 /2
1.6
Advanced Quality 40
0.5
First Response 30
0.7
StatPak
NEED THIS NUMBER
Murex
455
Serum
1.76
Uniform II
546
HIV1 /2
1.65

9. MATERIALS & METHODS… Specifications of HIV tests
Assay Name
No. of kit
HIV
type
Sample type*
Cost / test (USD)
Determine
100
1 / 2
BSP
1.2
Unigold 20
1.6
Advanced Quality 40
0.5
First Response 30
0.7
StatPak
Murex
455
Serum
1.76
Uniform II
546
1 /2
1.65
* BSP= whole blood, Serum and or plasma

10. MATERIALS & METHODS…
Rapid tests and double ELISA were run in parallel, blinded of the other tests’ results
Discordant results and samples from participants who were first time positives on ELISA were confirmed on Calypte Western blot
Two independent ELISA results from different manufactures were used as final result for double negative specimen
All tests were done in conformity with manufacturers’ instructions/guidelines

11. RESULTS 150 blood samples Rapid+2EIA/WB No link to EIA/WB
Blood samples used in the comparison
150 blood samples
Rapid+2EIA/WB No link to EIA/WB
(149 samples) (1 sample)
Analysis (149)

12. RESULTS
Summary of characteristic performance of tests used in evaluation (INCLUDE NUMBERS IN THIS SLIDE SINCE “ENRICHED” SAMPLE.)
TEST SE%(n=) SP% NPV% PPV% Efficiency%
Determine
Statpak
Unigold
First Response
Advanced Quality
Key:
SE= Sensitivity, SP= Specificity, NPV= Negative predictive value
PPV= Positive predictive value

13. RECOMMENDATIONS
Advanced Quality, StatPak, and First response rapid assays in our hands performed as well as other commercially available HIV tests indicating potential if adopted for HIV screening by demonstrating similar performance characteristics to other much utilized rapids in this region.
When possible before implementation, field sites should make attempt to evaluate new rapid assays and algorithms for use in context of their own setting.

14. ACKNOWLEDGEMENTS Rakai Participants
Calypte Biomedical Corporation and Intercross agencies, Kenya
National institute of Allergy and Infectious Disease International Center for Excellence in Research Program (ICER)