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2020 TB DIAGNOSTICS

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.

 

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.

75. Ensure the price of devices and comprehensive service and maintenance contracts are defined, transparent, consistent and in place across partners and countries.

76. Early engagement with international and national regulatory and guidance stakeholders to clarify and optimize regulatory processes for digital x-ray and imaging.

77. 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.

Updates

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