2018 DIAGNOSTICS

National governments, with support from implementing partners, commit to:

1. Scale up appropriate, timely, high quality, cost-effective early infant diagnosis, using comprehensive laboratory mapping and optimized use of all available diagnostic resources, recognizing the patient benefits of Point of Care (POC) Early Infant Diagnosis (EID) for timely diagnosis and ART initiation.

2. Prioritize effective, evidence-based case-finding strategies to increase demand for testing of children of all ages and improve patient identification, including testing all children attending nutrition, TB, and inpatient wards, testing of mother-infant pairs in immunization clinics, scaling up index testing, etc.

3. Develop strategies to optimize the use of new technologies and interventions in countries.

4. Work with national regulatory authorities to streamline procedures and strengthen the use of WHO prequalification listing when considering national regulatory approval.

5. Develop more accurate, transparent, and consolidated forecasts to support manufacturing and reagent availability.

6. Support multiplexing of available diagnostic technologies across programs for more optimal utilization of available platforms and wider access to testing.

7. Work towards eliminating user fees from diagnostic and health services in the public sector.

Ministries of Health and other partners commit to work with National regulatory authorities to:

8. Prioritize fast track national regulatory approval of EID and viral load (VL) products that have stringent international regulatory approval and/or WHO prequalification listing.

9. Accept WHO guidance suggesting countries should refrain from requiring national evaluation studies that would be duplicative, but instead adopt a rapid and streamlined registration and national approval process for EID and viral load products.

10. Prioritize the development and operationalization of collaborative regional registration schemes and take part in the collaborative registration procedure for diagnostics, to be developed by the WHO.

11. Develop and implement post market surveillance of diagnostic products.

12. Discourage and refrain from funding national evaluation studies that would be duplicative of studies done for WHO PQ listing or SRA approval.

Donors (Global Fund, PEPFAR, Unitaid) commit to:

13. Fund impactful technologies and interventions quickly.

14. Support in a transparent manner the procurement of commodities and operational costs to maintain and further scale-up POC EID, as well as viral load testing for infants, children, and pregnant and breastfeeding women, as an integral part of optimized and integrated national laboratory networks and in accordance with national EID and VL plans and targets.

15. Support the development of a competitive, healthy, and sustainable market for POC and laboratory technologies.

16. Continue to support WHO PQ to shorten timelines for dossier review and minimize time to national registration.

WHO commits to:

17. Develop and implement a sustainable and affordable collaborative registration procedure for diagnostics in 2019 and support national regulatory bodies to make use of it to streamline their national regulatory procedures.

WHO commits to:

18. Subject to support from donors (see 16 above), reinforce the capacity of its Prequalification of In Vitro Diagnostics programme, so that additional staffing can help to optimise process efficiencies and support transparent and predictable timelines for the review of HIV diagnostic products (in particular EID and VL products, and in alignment with WHO guidance).

19. In order to facilitate reduction of national evaluation studies (see points 9 and 12 above), provide relevant additional information within the public reports of products achieving prequalification status for increased data sharing to countries.

20. Provide additional guidance and support implementation on post-market surveillance and quality assurance to manufacturers, countries, and national regulatory authorities.

21. Develop guidelines and tools to support multiplexing of diagnostic technologies as well as viral load frequency for pregnant and breastfeeding women and children and consider novel interventions with patient impact evidence for review in next guidance review processes, including upgrading the POC EID recommendation.

Diagnostic manufacturers commit to:

22. Make every effort to stay in the EID market to ensure there is a sufficient testing capacity to reach and maintain accelerated Fast Track targets (95% of HEI tested by 2020 and beyond).

23. Ensure consistent reagent pricing across partners within countries and within regions, and provide a transparent breakdown of pricing for the products and services sold.

24. Consider moving from separate instrument, consumable, and service procurement towards more consolidated, ideally all-inclusive pricing models.

25. Provide service level agreements that clearly spell out key performance indicators POC, near POC, and high-throughput laboratory instruments, including target up-times and failure rate threshold (with consideration for different causes), plus a mitigation plan when the threshold is exceeded.

26. Consider the inclusion of a clinical indeterminate range in test result reports for more accurate diagnosis of infants per WHO guidelines.

27. Rapidly communicate stock shortages with major buyers and work on joint mitigation strategies.

Faith Based Organizations commit to:

Faith Based Organizations commit to:

28. Equip, mobilize, and support faith leaders, FBOs, people in places of worship, and the wider community to create demand for testing of infants and children.

29. Combat stigma and discrimination among faith leaders and within communities of faith.

30. Further collaborate and coordinate community mobilization, education and outreach to find otherwise hard-to-reach children, adolescents, youth and adults for age appropriate prevention education, testing and linkage to treatment and health and social support services and integrate into the national system.

31. Ensure FBO participation in local and national diagnostic product/supplies forecasting.

32. Support and participate in national efforts to improve the use and impact of pediatric diagnostics and develop national strategies to optimize the use of new technologies and interventions.

33. Work to implement new HIVST modalities (such as oral fluid testing) in communities and homes, where national polices and regulations allow for lay implementation with children.

All partners commit to:

34. Tackle the stigma and discrimination in communities, schools, and healthcare settings that prevent children living with HIV from accesing testing and treatment.

35. Promote provider initiated testing and counseling (PITC) of children outside PMTCT settings, testing of children of index HIV cases and siblings of HIV infected children, and pursue innovative avenues to identifying children living with HIV of all ages and ensuring access to testing and treatment.

36. Promote and support virological (rather than serological) testing at the 9 months of age time point for all HIV-exposed infants per WHO 2018 EID algorithm changes.

37. Support rational integration and scale up of point of care virologic platforms within laboratory networks for timely identification and monitoring of infants and children with HIV.

38. Increase literacy about viral load and promote a client-centered approach to support expansion of access to viral load for pregnant and breastfeeding women and children on treatment.

39. Advocate for the elimination of user fees from diagnostic and health services in both the public and private sector.