Overview of activities of the International Laboratory Branch C4G, GT, Aug 25th, 2009 John Nkengasong, PhD Chief, International Laboratory Branch Global AIDS Program CDC Atlanta.
Download ReportTranscript Overview of activities of the International Laboratory Branch C4G, GT, Aug 25th, 2009 John Nkengasong, PhD Chief, International Laboratory Branch Global AIDS Program CDC Atlanta.
Overview of activities of the International Laboratory Branch C4G, GT, Aug 25th, 2009 John Nkengasong, PhD Chief, International Laboratory Branch Global AIDS Program CDC Atlanta (N=43) PEPFAR I treatment Progress as of December, 2008 PEPFAR supported life-saving antiretroviral treatment for approximately 2.1 million men, women and children When PEPFAR started, about only 50,000 people were receiving treatment for HIV/AIDS in sub-Saharan Africa. “ PEPFAR LAZARUS What is the laboratory’s role in global public health? Molecular testing? Culture Cytometry Serology Microscopy Hematology and Chemistry Polio, Measles, Flu, Tuberculosis, Malaria, HIV/AIDS, Viral Hepatitis, Sexually Transmitted infections Programs Strengthening Laboratory Health Systems & Sustainability Training & Retention Systems Equipment Maintenance Systems Supply Chain Management System Laboratory Information Systems Sample Referral Systems Laboratory Services Microscopy Culture CD4 Chemistry Hematology Molecular Testing Policies Serology Laboratory Systems Quality Management System International Laboratory Branch at Global AIDS Program Shambavi Subbarao Associate Chief of Science John Nkengasong Jhosetta Goudelock Branch Chief Katherine Roeder Nuri Ali Chin-Yih Ou International Advisor for special projects Sherry Orloff Natasha Nyanin Mary Ewing Serology/Incidence Diagnostic Team Lead Public Health Advisor Molecular Monitoring Team Clinical & OI Monitoring Team Bharat Parekh Dennis Ellenberger Linda Parsons David Cross Team Leader Team Leader Team Leader Team Leader HIV Diagnostics Unit Mirielle Kalou Unit Lead Hetal Patel HIV Incidence Unit Bharat Parekh Acting Unit Lead Trudy Dobbs Infant Diagnostics/ Viral Load Unit Drug Resistance Unit Dennis Ellenberger Unit Lead Chunfu Yang Unit Lead Artur Ramos Vedapuri Shanmugam Clinical Monitoring Unit Larry Westerman Unit Lead OI/TB Unit Vacant (D, Kuehl replacement) Vacant Mary Garcia QA Specialist Bernice McClain Kyle Tholen Luciana Kohatsu Zilma Rey Karidia Diallo Oren Mayer Becky Anderson Al Garcia Yen Duong Vacant FTE Astrid Ortiz Josh DeVos Aminata Mboup Carole Moore Bereneice Madison International EQA Katy Yao Training Jane Zhou Reena Doshi Systems-Strengthening Team Vacant Dratin Castlin Mark DeZalia LIS Nick Wagar Ritu Shrivastava ACILT/PPP Jing Zhang Cynthia Warner SCMS/ Equipment PEPFAR Laboratory Program is a Critical Component of Health Systems Strengthening Mission: To support countries to strengthen sustainable, integrated laboratory systems to provide quality diagnostic services for effective implementation of prevention, surveillance and treatment programs across diseases (HIV, TB, Malaria, OIs) Number of laboratories by country (N= ~1,917) 400 371 350 311 274 300 254 250 250 200 150 150 117 97 100 66 53 50 0 10 30 36 141 Number of testing sites by country (N= ~16,470) 4500 4000 4000 3500 2724 3000 2200 2500 1900 2000 1203 1500 650 879 1000 500 0 412 200 27 173 31 441 1661 Serology Unit: Ongoing validation of new rapid test kits for inclusion in the USAID waiver list: – World-wide panel development (n=2,000), characterization – Rapid test validation – Evaluated 30 rapid test kits and recommended 18 to USAID Collection and characterization of specimen panel Some examples of test kits evaluated Serology Unit: Oral fluid tests Evaluation of new generation of rapid tests: – Oral Fluid tests DPP for blood, serum, plasma and oral fluid – Dual Path Platform from ChemBio – 4th generation Determine RT: Ag-Ab combo C Ag Ab 4th generation Determine test for detecting acute infection Serology Unit: Improve quality of HIV testing in PEPFAR countries: Training manual and guidelines – Training workshops or in-house training – Training manuals, Testing guidance, guidelines – Work closely with CT Team and WHO Training workshops and in-house training Serology Unit: – Develop and implement simple and practical QA strategies: • Dried tube specimens based Proficiency Testing • Retesting specimens from the field COUNTRY Total Number Tested Concordant (%) Discordant (%) Rwanda 288 288 (100.00) 0 (0.00) Haiti 512 511 (99.80) 1 (0.20) Cambodia 852 851 (99.88) 1 (0.12) Expanding DBS-based Early Infant Diagnosis of HIV Infection in PEPFAR Countries EID in >20 countries since 2005 2005 – Botswana, Rwanda 2006 – Mozambique, Uganda, Ethiopia, Namibia, Zambia, S Africa, Kenya 2007 – Malawi, Tanzania, Nigeria, Cote d’Ivoire 2008 and 2009 – Angola, DRC, Lesotho, China, Caribbean region countries (DR, Haiti, Guyana, Jamaica, Barbados (includes 6 OECS), Suriname, T&T, and Bahamas). Not shown on map – China and Caribbean Region countries Proficiency Testing Programs: Early Infant Diagnosis and Viral Load EID: tri-annual, voluntary DBS-based PT program for labs using DNA-PCR testing Viral load: Sept 2009, piloting PT program in 6 countries including Cote d’Ivoire, Ethiopia, Guyana, Mozambique, Namibia and Kenya Proficiency Program for Early Infant Diagnosis 90 Number of Countries 80 Number of labs Number of Countries 70 60 50 40 30 20 10 0 M 6 -r 0 a 0 nu J 6 S 6 -0 p e e D 0 c- 6 M 7 -r 0 a 0 nu J 7 S 7 -0 p e e D 0 c- 7 M 8 -r 0 a 0 nu J 8 S 8 -0 p e e D 0 c- 8 M 9 -r 0 a 0 nu J 9 Prevalence of Pre-Existing Primary Drug Resistance Mutations by HIV-1 Subtypes from Patients Starting ART 60 50 40 30 20 10 0 NRTI TOTAL (271) CRF_06 (12) NNRTI CRF_02 & CRF_02/G (101) G (134) Others (24) TB/OI Monitoring Unit: Training for in-country staff provided in BSL3 Laboratory – 2 to 4 week trainings provided for staff from Nigeria and Rwanda • • • • AFB smear microscopy Sputum specimen processing TB growth detection in liquid and solid media Identification of the MTB complex – – • Capilia immunodiffusion assay Molecular line-probe assay Molecular detection of resistance to RMP and INH Performing 1st and 2nd line drug susceptibility testing for Botswana and Nigeria Drug Resistance Surveys TB/OI Monitoring Unit: Standardized TB culture and identification course developed and presented at African Centre for Integrated Laboratory Training (ACILT) Content adapted from standardized CDC, WHO and NHLS training materials 23 participants trained in October 08 and March 09 courses, 15 to be trained in October 09. Participants from Botswana, Ethiopia, Kenya, Namibia, Nigeria, South Africa, Zambia Faculty from ACILT, CDC-ILB, FIND, BD, ASM ASM funded to translate and present course to Francophone and Lusophone countries in coming months ACILT TB culture course Participants from Ethiopia and Nigeria, Johannesburg, October 2008 Clinical Monitoring Unit Evaluation of CD4 assays- including new point-0f-care technologies Determine quality of result, performance characteristics, and service deliverables. CDC Atlanta Examine performance characteristic when looking at test quality indicators. Comparison with three established technologies commonly used – FACSCalibur, FACSCount, and Guava. Question vendors/manufacturers on postmarketing services. In resource-poor countries – Comparison with predicate instruments and determine performance characteristics in the field DGA/ILB Laboratory Systems Strengthening Team Safe specimen handling DGA/ILB Laboratory Systems Strengthening Team PPE training DGA/ILB Laboratory Systems Strengthening Team Hands-on-training DGA/ILB Laboratory Systems Strengthening Team On-site visits DGA/ILB Laboratory Systems Strengthening Team Bio-safety and PPE training Media Coverage of Stepwise WHO-AFRO Accreditation Health organizations launch new lab accreditation process Government and health officials from across Africa meet NEWS IN BRIEF Silos of National Reference Laboratories Disease-specific laboratories are a common practice HIV Reference Laboratory It is time we tear down the walls of disease- specific laboratories and strengthen common Public Health Laboratories? Synergies between Public Health Laboratories Clinical Labs Clinical Trial Laboratories Public Health Labs TB and HIV Labs in Chennai, India TB, HIV, Malaria - Integrated Training Center, Zaria, Nigeria Laboratory Information Systems Strengthening Critical unmet need for laboratory information systems in service-delivery level of laboratories Opportunity to strengthen workflow and increase lab data quality with use of simple laboratory information system Opportunities exist to improve service in all three phases of the total testing process • Pre-analytic • Analytic • Post-analytic Where do errors occur? 100% 80% Postanalytic Analytic 60% • But most opportunities exist outside the analytic Laboratorian’s Comfort Zone phase 40% Preanalytic 20% 0% (Plebani, 1997) DATA SOURCE Many Registries of the Primary Health Worker Origin of Primary Data DATA SOURCE Diaries Data Collection DATA SOURCE Specimen Logbook Data Collection DATA SOURCE Specimen Logbook with fully identified lab results Data Collection INFRASTRUCTURE Critical lab equipment rendered useless due to counterfeit plug adaptor Generation of Primary Data LAB WORKFLOW Creative approaches for managing work queue Origin of Primary Data Weekly Data, manually computed by the data entry operator Burden of Data Aggregation Data Storage and Retrieval Laboratory Information Systems Strengthening Approach Development of simple, user-friendly, infrastructure-sensitive, scalable LIS through collaboration with GT C4G Develop sustainable system Involve partners in the development and implementation of system Create a community of LIS developers, technical support specialists, and advocates on the African continent Laboratory Information Systems Strengthening Future Directions Incorporation/development of standardized lab data standards and data exchange protocols Integration of LIS with SCMS and HMIS Collaboration to Build Scalable Systems MOH Others PEPFAR Goals and objectives Goals and objectives Goals and objectives Reports Reports Reports Operations Access to data from Others Integrated Information Management Integrated LMIS Procurement Operations Warehouse Operations LIMS Lab Operations Integrated HMIS Pharmacy Operations Clinic Stock Clinic Operations Collaboration to Build Scalable Systems MOH Others PEPFAR Goals and objectives Goals and objectives Goals and objectives Reports Reports Reports Operations Access to data from Others Integrated Information Management HMIS Integrated Logistics Management Procurement Operations Warehouse Operations Pharmacy Operations Lab Operations Clinic Stock Clinic Operations