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In-vitro Diagnostic (IVD) Products

All diagnostic products procured through UNDP health procurement support must be 1) in conformity with WHO guidance (e.g., WHO Essential Diagnostic List - EDL), 2) consistent with relevant national laboratory policies and strategic plans, 3) take into account harmonized and standardized practices (e.g., national testing algorithms), 4) consider the physical infrastructure and biosafety level of the laboratory, 5) must take into account the structure, functioning and capacity of the laboratory system (human resources, network, communication system, and specimen transport systems at and between each level of service), and 6) be effectively coordinated with laboratory services and other funding sources.

For entities submitting requests to UNDP for the procurement of diagnostic products that are not included WHO guidance, the requests should be supported by an appropriate justification with supporting evidence (e.g., National Testing Algoritm). These will be assessed by the UNDP QA Expert Committee to determine compliance with UNDP’s general principles for the procurement of health products. Such requests should be submitted to the GFPHST Senior Health PSM Advisor through the GFPHST HPM Specialist focal point.

All diagnostic products must be procured using their generic name or description. Where 1) a National validated testing algorithm, or 2) Closed equipment testing systems that require reagents and consumables that are specific to a diagnostic platform, or 3) National standardized and harmonized practices exists, it may be permissible to procure using a brand (proprietary) name and/or specific product catalogue number. Using no or restricted competition requires prior approval from GFPHST HPM Specialists and, when grant funds are being used, the Global Fund.

While WHO has recommended diagnostic and testing algorithms for HIV/AIDS, tuberculosis (TB), malaria and hepatitis, and these can be helpful to governments as reference for the development of national guidelines, it is important that national algorithms are established and are tailored to local requirements, ensuring national ownership of the guidelines.

Additional guidance to support this area of work are also available through a number of resources listed below:

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