2020 TB DIAGNOSTICS
National governments, with support from implementing partners and FBOs, commit to:
1. Adopt and implement WHO TB guidelines as relevant for infants and children in case-finding, screening, and testing.
2. Scale up available, appropriate, timely, quality assured pediatric TB diagnostics, using comprehensive diagnostic network mapping and optimized use of all diagnostic resources to maximise paediatric case detection.
3. Ensure follow-up, screening and appropriate care for children who are a household contact of a person living with TB, and that pediatric case-finding is prioritized.
4. Implement rapid molecular assays for detection of TB in infants and children, including use of stool and other non-sputum specimens endorsed by WHO.
5. Implement the TB-LAM assay and/or similar urine-based lateral flow assays for routine use in both TB and HIV national programs in line with the latest WHO recommendations to support identification of TB in all HIV-infected infants and children.
6. Incorporate costed and budgeted requests for interventions for pediatric TB diagnosis, including procurement, training, and case-finding interventions, into Global Fund and PEPFAR requests.
7. Optimize infant and children case-finding approaches to ensure increased and equitable access to screening and testing as well as linkage to treatment, including preventive treatment.
8. Work with researchers and relevant experts to develop pediatric specimen banks/repositories to support faster studies of new TB diagnostics and ensure open access to academic groups and manufacturers.
9. Work with national regulatory authorities to register diagnostic assays and streamline procedures while ensuring the use of WHO approved products when considering national regulatory approval.
10. Support sharing of available diagnostic platforms and associated networks across programs to attain wider access to testing, for more optimal utilization of available platforms, more efficient systems, and improved sustainability.
11. Remove barriers to accessing screening and preventive treatment for healthy children who are exposed to TB (e.g. provide transport vouchers, home-based screening and treatment, etc.).
Ministries of Health and other partners commit to work with National regulatory authorities to:
12. Support optimal access and supply to TB diagnostics through efficient registration of WHO recommended diagnostics and not taxing public goods.
13. Implement pre-qualification assessments of TB in vitro diagnostics to assess quality, safety and performance of specific products, as a quality assurance mechanism complementing WHO policy recommendations.
14. Streamline national regulatory approval of TB diagnostic products that have been assessed according to stringent standards for quality, safety and performance.
15. Develop and implement post market surveillance of diagnostic products.
Donors commit to:
16. Support the development of a competitive, healthy, and sustainable market for point-of-care and laboratory-based testing for TB infection and disease as well as digital x-ray technologies.
17. Consider increasing investments in diagnostic research and development, case-finding, and scale-up of product procurement in high TB burden countries.
18. Support country level roll-out of new tools for pediatric TB detection, including testing of nasopharyngeal aspirates, stool, urine, and other non-sputum specimens.
19. Consider support to build evidence base for product development, evaluation, and WHO guidance.
20. Add paediatric-specific diagnostics and associated specimen collection devices/consumables to available diagnostics catalogues.
21. Include TB-LAM and other urine-based lateral flow assays in procurement considerations in all countries but especially for high HIV burden countries.
22. Support the development of pediatric X-ray libraries to facilitate the development of machine learning algorithms for the interpretation of pediatric chest X-rays.
23. Support more coordinated diagnostic network strengthening and optimization exercises, led by national governments, across diseases (TB and HIV as well as other key diagnostics).
24. Support the development of biomarker-based tests for infants and children, as well as tests and/or testing procedures that use alternative (non-sputum-based) specimens.
25. Facilitate appropriate budgeting and access to quality-assured TB diagnostics at affordable prices and ensure a sustainable market and supplier accountability.
WHO commits to:
26. Provide guidance to manufacturers, donors, and other stakeholders on the diagnostic approval processes to ensure a consistent baseline level of evidence for WHO-convened expert reviews.
27. With appropriate evidence, prioritize the timely review of additional urine-based lateral flow assays, molecular technologies (both point-of care and laboratory-based), alternative (non-sputum-based) specimen types, and novel testing approaches to provide better tools for pediatric TB detection and encourage and introduce market competition.
28. Support national regulatory bodies to develop or leverage regulatory procedures based on WHO assessments.
29. Develop more simplified pediatric case-finding algorithms and implementation guidance for collecting, processing and testing various non-sputum specimens, in collaboration with the Global Laboratory Initiative and Child and Adolescent TB Working Group.
30. Generate target product profiles for diagnostic assays needed for children.
31.Consider clinical scoring and symptom-based diagnostic algorithms while awaiting bacteriologic confirmation.
Diagnostic manufacturers commit to:
32. Prioritize the pediatric TB diagnostic space to ensure there are improved tools for pediatric TB infection and disease detection to reach and maintain targets.
33. Develop quality-assured, affordable, less invasive alternative specimen processing methods or products (not based only on sputum) that can be used for the pediatric population, such as urine, stool or saliva.
34. Ensure diagnostic studies include children and alternative (non-sputum-based) sample types.
35. Expedite development of point-of-care biomarker-based tests for infants and children.
36. Consider moving from separate instrument, consumable, and service procurement towards more consolidated, all-inclusive pricing models, for both laboratory-based and point-of-care technologies.
37. Provide service level agreements that clearly spell out key performance indicators for all technology types and their offered service plans, plus a mitigation plan when the threshold is exceeded.
All partners commit to:
39. Support rational and coordinated integration, network optimization and scale up of point of care molecular and TB-LAM technologies within diagnostic networks for timely identification and monitoring of infants and children with TB and HIV.
40. Develop pediatric sample banks/repositories to support faster studies of new TB diagnostics and ensure open access to academic groups and manufacturers.
41. Train skilled and confident health workers at all levels to execute recommended screening and testing approaches and algorithms and promote the capacity of community health workers or other community cadres to conduct household contact tracing, screening of identified paediatric contacts of TB index cases, counselling, initiation of TB preventive treatment (if permitted by national guidelines), and monitoring of treatment adherence.
Academic groups commit to:
42. Incorporate the development of pediatric specimen banks/repositories into studies to support faster clinical trials of new TB diagnostics and ensure open access to academic groups and manufacturers.
43. Support pediatric sample repositories, including non-sputum less invasive samples, for more expeditious technical evaluations of new diagnostics and regulatory approval processes.
44. Incorporate the development of pediatric chest X-ray image libraries into studies to develop and support improved machine learning algorithms for computer-assisted X-ray interpretation and ensure open access to other research groups and manufacturers.
Global Fund commits to:
45. Support countries’ TB case finding strategies that address children and country-level uptake and scaling up of new tools for TB diagnosis in children, as per international guidance.
46. Support more coordinated diagnostic network strengthening and optimization exercises, led by national governments, across diseases (TB and HIV as well as other key diagnostics).
Unitaid commits to:
47. Supporting the TB diagnostic agenda through our grants (TB Speed – Université de Bordeaux and all consortium members and target countries, Seq&Treat – FIND, and WHO).
48. Identify and establish effective collaboration and funding support to advance the application of new technologies for delivery of improved paediatric diagnosis, using other samples than sputum, such as stools and nasopharyngeal aspirate.
49. Promote integration of different services to increase detection and treatment of children with TB.
EGPAF commits to:
50. Through its Unitaid-funded project CAP-TB, improve pediatric TB care, finding more children with latent or active TB, and putting them on appropriate treatment. This includes improving the increased access and use of TB preventive Treatment in the high-risk population of child contacts <5 and CLHIV.
Abbott commits to:
51. Develop a new, more sensitive lateral flow TB LAM RDT with a broader indication for use including in TB without HIV co-infection in both adults and children.
52. Offer access pricing for TB testing for laboratory-based, high-throughput devices to complement decentralized testing, which will include pursuing WHO PQ (when relevant for TB) as well as the WHO guidance and recommendation process.
Cepheid commits to:
53. Support further decentralization of testing through release of the GeneXpert Omni technology in 2021 in a limited set of countries; broader market release in 2022.
54. Continue development of a blood-based assay for TB.
55. Continue the work on the stool sample validation with FIND for MTB/RIF assay with an estimated launch in 2021.
FujiFilm commits to:
56. Accelerate introduction of the SILVAMP TB LAM test in limited-resource settings through technology transfer to a new manufacturing site that can allow for transparent, lower, and fair pricing in line with affordable pricing of TB diagnostics and ensure capacity of the manufacturing site can support potential volumes.
57. Accelerate performance study for assay in HIV-positive and HIV-negative pediatric populations.
58. Offer access pricing and prospective reductions based on global volume thresholds; publish the volumes procured quarterly.
59. Prepare a roadmap towards WHO endorsement/prequalification.
Hain commits to:
60. Prioritize attainment of WHO recommendation of the FluoroType MTBDR assay.
61. Prioritize obtaining waivers for GenoType and FluoroType assay technologies for countries under US embargo.
62. Offer access pricing and prospective reductions based on global volume thresholds; publish the volumes procured quarterly.
63. Consider introduction of a diagnostic connectivity solution that is API-capable for automatic reporting of line probe assay test results to users and other information management systems.
Molbio commits to:
66. Prioritize regulatory approvals where required for introduction of Truenat TB tests in additional high TB burden countries.
67. Share a plan for service and other forms of technical support in international settings with international partners for comment and transparent review/ implementation.
68. Proactively define standardized Key Performance Indicators for system and test performance.
69. Prioritize the regulatory processes of HIV assays for infant diagnosis and viral load.
70. Offer access pricing and prospective reductions based on global volume thresholds; publish the volumes procured quarterly.
71. Prioritise the development of resistance markers for TB as well as multiple sample types and to work on a TB +COVID test.
Manufacturers of Chest X-ray (digital x-ray: FujiFilm, Philipps, Delft, MinXray…) commit to:
77. Ensure the price of devices and comprehensive service and maintenance contracts are defined, transparent, consistent and in place across partners and countries.
78. Early engagement with international and national regulatory and guidance stakeholders to clarify and optimize regulatory processes for digital x-ray and imaging.
79. For manufacturers that offer software for the computer-assisted detection of TB using artificial intelligence, ensure the software is capable of analyzing images from children and adolescents.