Strengthening Lab Capacity for TB Diagnosis and Care in LMICs Raising the Bar June 20, 2018 Advanced TB Diagnostics Course McGill University, Montreal Kathleen England, PhD MSc TB Diagnostics Advisor MSF Access Campaign, Geneva
Deep Diagnostics By Alice Street URL: https://limn.it/deep-diagnostics/ the piece shows how the global health community systematically promoted empirical or syndromic treatment in low income settings, because building a reasonable lab infrastructure was considered too difficult and expensive, and syndromic treatment was considered enough for impoverished settings - M.Pai 1990 s push for RDTs Seriously neglecting investments in laboratories Improvement of labs and strengthening systems is still considered too expensive and difficult by most governments and donors. - Stigmatizing and Demotivating Major impact = Donor driven implementation Silos, which fragment care and moved away from integrated patient centric services. TIME FOR CHANGE RAISE THE BAR! Focus on building stronger integrated lab networks Balance the use of RDTs with more reliable laboratory tests Establish comprehensive diagnostic services
Network Assessments What tools are Where? What tools are Needed? Who has Access? 1 st Edition General lab test for routine patient care require for communicable and noncommunicable diseases. Disease specific IVDs for detection, diagnosis, and monitoring (HIV, TB, Malaria, HBV/HCV, HPV, Syphilis) Can the EDL drive network strengthening and capacity building?
What is Capacity Building? Lab Strengthening? T T T echnologies ests raining Skills development Standardization (SOPs) Quality (QMS)
What is Missing? Systems Integration Private Sector Patient Perspective
Environment & Infrastructure CLEAN Temperature Humidity Controls In the 21 st Century these essential features are a MUST for labs at every level of a healthcare system in order to provide accurate and reliable diagnostic services. It is time to push Governments to Invest in Laboratory Services for Quality Care RAISE the BAR to provide the FOUNDATION for laboratories to support medical care.
Rapid Information Transfer 21 st Century Data Management & Reporting Doctor/HCW DEVICE Patient MoH EHR
*2017 WHO TB Report Data (216 counties) Data LINKAGES Connectivity & LIMS DX CONNECTIVITY NETWORK Ø GxAlert has the largest global fleet connecting a variety of instruments In 41 countries. Ø Others C360 (Cepheid) Data-To-Care (Savics) Blue Frontier (FIND) EHR WHO TB Reporting tools do not collect information on LIMS implementation or progress of e-linkages of lab data to EHRs.
Specimen Referral Linkages -Integrated Transport- Collection Sites Zonal Courier Systems Zone A Various Transport Modes Hub & Spoke Zone B Zone C HC HC Zone D (warm/lush) HC HC HC Various Models Various Modalities Various Specimens
14 country survey on specimen referral Recent MSF Survey 2017 (16 countries): 10/14 (71%) reported have a specimen referral system 3 indicated their system were efficient Only 2 stated plans to invest WHO Reporting tool does not collect information on specimen referral networks or linkages to testing. (unpublished survey, K. England, 2015)
Qualified Human Resources 1) Need for Specialists: Microbiologists Molecular Biologists Information Systems Specialists Bioengineers Instrumentation Specialists Medical Technologists Data Managers Supply & Procurement Officers Quality Officers BioSafety Officers Lab Managers Network Coordinators 2) University Engagement for curriculum development to support national programs needs by building the cadre of skilled laboratorians through quality degree/ certificate programs. 3) Transition away from donor driven training and establish national mechanisms within the education system (Ministry of Education) that are more sustainable. 4) Invest in HR: provide equitable wages and benefits to keep experienced staff.
Lab Waste Management What are we doing with lab waste? Not included in WHO reporting.
Engaging Private Sector Labs Where do patients seek care? 13-countries in analysis ~60% seek initial care in Private Sector Microscopy coverage limited at entry levels Xpert coverage was not evaluated Need To Ensure Private Sector Labs have recommended tools for TB. - Diagnostic Algorithms - Xpert MTB/RIF - Linkages to follow-on testing like DST - Patient Monitoring
Engaging Private Sector Labs Affordability Need for Government Regulations on Pricing [ Ponnudurai et al. (2018) Journal of Epidemiology and Global Health ]
Integrated Lab Services 1) Begins with HIV and TB programs Testing for TB expanded to ART centers Testing for HIV implemented at TB centers Increased coordination of common interventions Sharing resources for common initiatives Increased cooperation to provide patient centered care 2) Integrate Health Services Patient Focus 94% of countries rely on GF to support Xpert Network Elimination of parallel programs HCV$ 67% rely Building on GF cooperative and additional strategies donors to support 95% of network activities. HIV$ Only 6 Linking countries public noted and some private sector domestic allocation. 50% will Pool face Resources substantial (Global changes Fund Transition) due to GF transitioning. 3) Integration of Systems Laboratory Data Management Procurement & Distribution Specimen referral Community-based support NCD$ MCH$ TB$ NTD$ MAL$ In the MSF 16 country survey (2017) Xpert Network Resources
TB Diagnostics Where are we today?
WHAT IS MISSING?? Routine ADSM Testing: Patient monitoring to improve treatment outcomes
WHO End TB Strategy ü Xpert MTB/RIF ü 2 nd Line LPA ü 2 nd line cdst Patient diagnosed with RR-TB (Xpert MTB/RIF = initial test) SL-LPA direct 80% interpretable 20% uninterpretable 2 nd line cdst in high prevalence FQ/SLID FQ-S / SLID-S FQ-R / SLID-S FQ-S / SLID-R FQ-R / SLID-R No result SL-LPA Indirect testing Initiate the shorter MDR-TB regimen Initiate optimised longer MDR-TB regimen Perform Culture
Xpert Capacity Study - 30 HBTB Countries The WHO Excel tool for calculating country-specific targets for laboratory strengthening and capacity building Initial Test for ALL Max Testing Capacity @ 4 tests/module/day 240 workdays/yr Calculation of country-specific targets for microscopy, WRDs (including Xpert MTB/RIF), culture/dst capacity Values in red should be entered or adjusted when possible based on actual country data and practices TB epidemiology Pulmonary, bacteriologically confirmed New cases: 124'604 Relapse cases: 3'637 Pulmonary, clinicially diagnosed New cases: 45'009 Relapse cases: 3'795 Extrapulmonary New cases: 43'549 Relapse cases: 1'654 Total new cases notified 213'162 Total relapse cases notified: 9'086 Previously treated cases, excluding relapses 1'673 Total cases notified 223'921 % of TB cases that are children 0.042 % of TB cases that are adult: 0.958 % of TB cases that are HIV-positive 0.020 % of TB cases that are HIV-negative/unknown: 0.980 HIV-positive people clinically screened for TB 13'500 Planned number of RR/MDR-TB cases to be detected (and treated): 5'300 11/30 (37%) countries need more modules Xpert MTB/RIF Although we know Annual notification number of Xpert rates MTB/RIF are tests low, the first step For PLHIV with signs and symptoms of TB: 4'100 is to recognize the needs in order to test current rates. For children with signs and symptoms of TB: 56'000 For people at risk of having drug-resistant TB: 59'200 For previously untreated HIV-negative adults with signs and symptoms of TB: For TB cases for DST purposes (excluding those getting Xpert MTB/RIF as initial test): Total annual number of Xpert MTB/RIF tests 1'170'200 0 1'290'000 Target number of GeneXpert modules 1344
LPA in-country No LPA = (17%) No 2nd line LPA (25%) Azerbaijan Belarus Kazakhstan Kyrgyzstan Peru Rep. Moldova Somalia Tajikistan Ukraine Uzbekistan Bangladesh DPR Korea Pakistan Philippines Russia Viet Nam Cambodia Sierra Leone Angola China DR Congo Ethiopia India Indonesia Kenya Mozambique Myanmar Nigeria PNG South Africa Thailand Zimbabwe Brazil Central Afr. Rep. Congo Lesotho Liberia Namibia UR Tanzania Zambia WHO reporting tools do not specifically request information on instrument capacity, annual 2 nd -line LPA testing rates, or results. (FQ, SLIs) No forecasting tool for 2 nd - line LPA (most countries do not know prevalence of FQ or SLI resistance). Botswana Cameroon Chad Ghana Guinea-Bissau Malawi Swaziland Uganda No data on implementation/use within national algorithms? WHO 2017 Reporting data
2 nd Line cdst In Country None External Azerbaijan Belarus Kazakhstan Kyrgyzstan Peru Rep. Moldova Somalia Tajikistan Ukraine Uzbekistan Bangladesh DPR Korea Pakistan Philippines Russia Viet Nam Cambodia Sierra Leone Angola China DR Congo Ethiopia India Indonesia Kenya Mozambique Myanmar Nigeria PNG South Africa Thailand Zimbabwe Brazil Central Afr. Rep. Congo Lesotho Liberia Namibia UR Tanzania Zambia Botswana Cameroon Chad Ghana Guinea-Bissau Malawi Swaziland Uganda WHO HAS ACCESS? How will Sequencing fit in? WHO 2017 Reporting data
Push for Quality QMS implementation and progress TB SLMTA program in 10 countries, 37 labs since 2013 Implementation of QMS and progress towards accreditation of NTRLs in Africa - Albert et al. (2017) AJLM
NEED to invest in QUALITY FIND Survey Conducted in African Region 47/49 NTRLS from WHO African Region 21 labs (43%) received TB SLMTA/SLMTA 10 Actively using GLI tool EQA programs - 95.8% for microscopy - 60.4% for 1 st line cdst - 25.0% for 2 nd line cdst - 22.9% molecular testing 28.6% NTRLs have accreditation interventions in strategic plans.
Raise Your Bar Network Assessments Establish a National EDL Build Stronger Systems Invest in HR Solutions Push Integration Link-In Private Sector Better Forecasting Set Diagnostic Targets Ensure Quality Increase Domestic Investment Understand the Patient Perspective