2020 HIV DIAGNOSTICS

The Ministry of Health of Zimbabwe commits to:

1. Continue funding Early Infant Diagnosis and viral load testing through point-of-care machines.

2. Expand access to urine-based LF-LAM assays for infants and children living with HIV.

PEPFAR commits to:

3. Ensure all children of parents living with HIV are offered HIV testing services in collaboration with implementing partners and faith-based partners.

WHO commits to:

4. Maintain and scale-up a sustainable and affordable collaborative registration procedure for diagnostics and support national regulatory bodies to make use of it to streamline their national regulatory procedures.

5. Develop and disseminate clearer procurement guidance for countries regarding the proposed and suggested remaining shelf-life of molecular diagnostic tests.

6. Expedite release of recent clinical and service delivery diagnostics-related guidance and recommendations in Q2 of 2021.

Diagnostic manufacturers commit to:

7. Making all-in pricing for both laboratory-based and POC technologies more affordable, accessible, and transparent.

USFDA commits to:

8. Work with diagnostics manufactures to use all regulatory tools available, such as breakthrough designations and leveraging existing data from outside the US, to expedite review of early infant diagnostics for HIV.

CHAI commits to:

9. Prioritize integration of systems and device-sharing across HIV and TB programs, including mapping of systems and diagnostic network optimization.

10. Work with Ministries of Health to improve and expand case-finding strategies and focus on priority entry points and index testing.

11. Incorporate LF-LAM and CrAg testing for infants and children with advanced HIV disease.

CRS commits to:

12. Continue to strengthen and expand case-finding through completion of studies of parent-assisted testing intervention in Zambia and Uganda and sharing quickly with WHO and other interested stakeholders.

EGPAF commits to:

13. Work with civil society, communities, governments and multilaterals to scale up access to POC EID through advocacy and technical leadership.

14. Work with governments, FBOs, and health care workers to implement evidence-based strategies for pediatric HIV case finding, especially for older children, and increase demand through community-led education to ensure that all children along the continuum of care are reached.

15. Optimize POC EID by promoting integrated disease testing for childhood HIV and TB on the same platform.

GNP+ commits to:

16. Promoting peer to peer support structures to promote greater use of point of care early infant diagnosis.

17. Advocacy of implementation and involvement into the design of the programs of community organizations and advocates.

18. Treatment literacy awareness, building trust, provision of information, encouragement of men to engage in health care needs of their family, and support community based organizations

Unitaid commits to:

19. Continue supporting the pediatric diagnostic agenda as per the Plan of Action through implementing partners (including, for year 2021, CHAI) and WHO’s Prequalification Program and WHO HIV/Hepatitis/STIs department.

20. Further generate evidence on optimal deployment models, impact and cost-effectiveness of new and existing technologies.

21. Support optimal use of technologies across different laboratory tiers and disease areas (including integration with TB and coinfections/comorbidities services).

22. Support further discussions with manufacturers of relevant diagnostics products to optimize pricing and supply terms towards affordable and accessible options.

Abbott commits to:

23. Recommit to offering a $20 all-inclusive price per test (covering instrument, connectivity, service and maintenance) for the m-PIMA qualitative (EID) and viral load assays based on minimum volume thresholds.

Cepheid commits to:

24. Launch an all-inclusive ceiling price (including instrument, cartridges, service and maintenance, etc) of $14.90 for virology tests, including HIV, HBV, HCV, and HPV, in January 2021.

25. Reduce the price per test for HIV, HBV, HCV, HPV molecular tests in 2021 for those countries unable or not yet ready to access the all-inclusive program.

Hologic commits to:

26. Continue all-inclusive access program across HIV, HBV, HCV, and HPV assays.

Roche commits to:

27. Offering access pricing for technologies that are transparent, consistent, and applicable across assays and donors/procurers and working with donors/procurers to further refine pricing details and transparency.

28. Offer all assays, including HIV, HCV, HBV, HPV and TB on all platforms, including the cobas 4800, 6800, and 8800.

29. Continue to support and strengthen a shared and integrated diagnostic network as well as multi-assay capability on current instrumentation for further optimization and utilization of platform capacity and access to testing.

30. Ensure the plasma separation card is affordable and consider expanding accessibility to other, non-proprietary technologies.