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.

Slides:

Advertisements

Similar presentations

Module 4: HIV Testing Strategies and Algorithms. 2 Learning Objectives At the end of this module, you will be able to: Discuss the process for developing.

Advertisements

Performance of Bio-Rad Genetic Systems HIV-1/HIV-2 Plus O EIA Followed by Multispot or OraQuick Advance in a Dual Immunoassay HIV Testing Strategy Laura.

Comparative Performance of Dual 3rd Generation Immunoassays as a Potential Laboratory-Based HIV-1/2 Testing Strategy. B. Bennett, S. Fordan, O. David,

Pediatric Diagnosis of HIV-1 Infection Using Dried Blood Spots Chin-Yih Ou, PhD NCHSTP/DHAP Centers for Disease Control and Prevention.

Evaluation of HIV Rapid Diagnostic Devices National STD Prevention Conference San Diego, CA 6 March 2002 Jennifer A. Malia, MS, MT WRAIR.

Comparison of the HIV LIA vs WB on HIV-Negative Samples CDC-HIV Diagnostics Meeting “New Diagnostic Technologies” Dec 5-7, 2007 Dr. John Kim National Laboratory.

Version 11Page 1 of 6 Improving Identification of Patients Infected with HIV Using Rapid Testing in the Emergency Department: A Systems-Based Approach.

Can Sequentially Reactive EIA’s Replace HIV-1 Western Blot Testing? Robert A. Myers Ph.D.

12/6/07 v.3CDC 2007 HIV Diagnostic Conference1 Diagnosis of HIV-1 Infection in Phase I & II HIV Vaccine Trials RW Coombs 1, J Dragavon 1, B Metch 2, CJ.

CDC HIV Diagnostics Conference December 5-7, 2007 Sensitivity of OraQuick and Early Generation Enzyme Immunoassay (EIA) within a Pooled HIV Nucleic Acid.

Routine HIV Screening in Health Care Settings David Spach, MD Clinical Director Northwest AIDS Education and Training Center Professor of Medicine, Division.

Increasing Our Reach through Rapid HIV Testing Bernard M. Branson, M.D. Chief, Lab Determinants and Diagnostics Section Centers for Disease Control and.

Epidemiology of HIV-2 infection in the U.S, Lata Kumar MS, MPH Richard Selik MD Division of HIV/AIDS Prevention National Center for HIV/AIDS,

STUDY DESIGN FOR DIAGNOSTIC STUDY FOR MELIOIDOSIS Dr Direk Limmathurotsakul, MD MSc PhD.

Can a second rapid HIV test discriminate false positives as effectively as a Western Blot? The NJ Experience Evan M. Cadoff, MD Robert Wood Johnson Medical.

Enhancing HIV/AIDS Surveillance in California California Department of Public Health Office of AIDS Guide for Health Care Providers.

Evaluation of Commercially Available HIV Assays to Address Alternative Screening/Diagnostic Algorithms S. Michele Owen, Ph.D. Laboratory Branch Division.

Preventing HIV/AIDS There is no way to tell just by looking whether a person is infected with HIV. Because people are unaware that they are HIV-positive,

Linked Testing Using Rapid HIV Tests for Antenatal Care Sentinel Surveillance in Resource-Limited Settings Evidence from Angola’s Experience in 2009 James.

HIV Testing CDC power point edited by M. Myers

Guidelines for Laboratory Testing and Result Reporting for Antibody to Hepatitis C Virus Miriam J. Alter, Ph.D. Division of Viral Hepatitis Centers for.

APHL Survey HIV Diagnostic Testing Utilization Barbara G. Werner, PhD MA State Laboratory Institute February 28, 2005.

Shelley Facente, Thomas Knoble, Omar Menendez, Teri Dowling San Francisco Department of Public Health, HIV Prevention Section Kevin Delaney Division of.

HIV Screening and Women’s Health Health Care Education & Training, Inc. Originally developed by: Section 5: Test Options.

Incorporation of the Aptima® HIV-1 RNA Assay into Serodiagnostic and Rapid Test Confirmation Testing Algorithms to Resolve Discordant Serological Results.

HIV Testing Quality Assurance and Quality Control

Results from the LA rapid testing study: What can they tell us about proposed point of care strategies? Kevin Delaney, MPH Division of HIV/AIDS Prevention.

Implementing Rapid HIV Testing in the United States Bernard M. Branson, M.D. Centers for Disease Control and Prevention Overview and Background.

CLINICAL TRIAL OF THE HEMA-STRIP HIV RAPID TEST USING FINGERSTICK BLOOD, WHOLE BLOOD, PLASMA, AND SERUM Niel T. Constantine 1, Dan Bigg 2, Daniel Cohen.

Performance of rapid HIV tests used singly and in combination: Moving toward a point of care diagnosis. Kevin Delaney, MPH HIV Diagnostics: New Developments.

Figure 1 A Case Series of Discordant Laboratory Results with Statewide Rapid HIV Testing in New Jersey Eugene G Martin, PhD 1, Gratian Salaru, MD 1, Sindy.

Unit 1: Overview of HIV/AIDS Case Reporting #6-0-1.

RESULTS Rapid testing started at one publicly funded counseling and testing site in New Jersey on November 1, Through December 31, 2004, 48 sites.

1 Counseling and HIV Testing HAIVN Harvard Medical School AIDS Initiatives in Vietnam.

Further information: Performance of HIV Enzyme-Immunoassays on Dried Blood Spots for Quality Control of HIV Testing Dennis Olara 1,

Effects on diagnosis of HIV infection using two HIV rapid tests and linkage to ART in health facilities in China Hao Wu Director of infectious disease.

CATHERINA JEMMOTT NOVEMBER 26TH, health districts 7 district health teams 52 health centre/clinics 2 district hospitals Main hospital in Roseau.

RETROVIRIDAE GENUS: ONCOVIRUS: HTLV-1 and HTLV-2 SPUMAVIRUS LENTIVIRUS: HIV-1 and HIV-2.

Performing HIV Rapid Tests

Self-taken extragenital samples compared with clinician-taken extragenital samples for the diagnosis of gonorrhoea and chlamydia in women and MSM Janet.

Ethiopia Demographic and Health Survey 2011 HIV Prevalence.

Global Rapid Diagnostic Leader SD. 2 HIV-2 positive HIV-1 positive 1 drop of blood (Simple) Wait in 1~5 Min. (Fast) Interpret the result visually (Accurate)

LOW HCV PREVALENCE AMONG HIV+ INDIVIDUALS IN SUB-SAHARAN AFRICA

Performance of a diagnostic test Tunisia, 31 Oct 2014

Matilu Mwau, M.D., MTM, D.Phil(Oxon)

Abbott HCV core Ag and HCV RNA Comparison Study

BREAST CANCER IN SETTING OF HIGH HIV PREVALENCE

Developing a Comprehensive Site Selection Process for a Cancer Network in a Resource-Limited Settings in Sub-Saharan Africa Meg Wirth AMC Operations &

Introduction Results Conclusions Methods

California Clinical Laboratory Association

Rapid Diagnosis of Dengue virus

In the Footsteps of the WHO – Rapid HIV Testing in America

Provider Initiated HIV Counseling and Testing

Global HIV Diagnosis Market to Witness 10.6% CAGR during 2017 – 2023.

Opportunity Analysis and Industry Forecast, HIV Diagnosis MarketHIV Diagnosis Market Top Key Players, Trends, Share to 2023tein Market.

Do Patients adherent on PrEP exposed to HIV have seroconversion symptoms & falsely reactive HIV tests? Mark Roche1, Elaney Youssef1, Yvonne Gilleece¹,

How do we judge efficacy of a screening test?

Diagnosing Infections

Centers for Disease Control/Food and Drug Administration algorithm for second-generation HIV tests (20). †, an immunofluorescence assay (IFA) for HIV-1.

1985: First HIV-1 ELISA Approved by FDA

A CASE SERIES OF DISCORDANT LABORATORY RESULTS WITH RAPID HIV TESTING

Toward a More Perfect World

TRACE INITIATIVE: Practical Scenarios

Challenges for Blood Donor Confirmatory Testing Algorithms

Performing Sedia Asante: Testing algorithm

Preparation of QC and Training Panels

Overview of RTRI: Assay Principle and Test Performance

Performing Maxim Swift RIA: Testing algorithm

Assessment of risk factors for hepatocellular carcinoma in HIV care and treatment programs across 31 countries: a cross-sectional survey within IeDEA C.

Presentation transcript:

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

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.

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.

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

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

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

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)

MATERIALS & METHODS… Specifications of HIV tests Assay name No. of tests @ 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 1.0-2.0 Murex 455 Serum 1.76 Uniform II 546 HIV1 /2 1.65

MATERIALS & METHODS… Specifications of HIV tests Assay Name No. of tests @ 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 1.0-2.0 Murex 455 Serum 1.76 Uniform II 546 1 /2 1.65 * BSP= whole blood, Serum and or plasma

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

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)

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 100 85.1 100 67.3 88.6 Statpak 100 99.1 100 97.2 99.3 Unigold 100 97.4 100 92.1 98.0 First Response 100 98.3 100 94.6 98.7 Advanced Quality 100 100 100 100 100 Key: SE= Sensitivity, SP= Specificity, NPV= Negative predictive value PPV= Positive predictive value

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.

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)