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Diagnostics for Research Use Only (RUO)

Research use only (RUO) products are products intended for research procedures and not intended for the diagnostic or treatment management of a specific patient. RUO reagents and equipment are not subject to IVD or “medical devices” regulatory requirements and, thus, are not subject to evaluation for accuracy, specificity, precision, and reproducibility, and any evidence provided with RUO products is not certified by a regulatory or independent authority. Therefore, these items should only be used by experienced scientists, biologists and/or microbiologists in an authorized laboratory following strict procedures.

RUO reagents and instruments can only be procured and used for research use, including genomic sequencing purposes, and epidemiology purposes, and may not be used for in vitro diagnostic procedures.

NOTE

it is possible that products, which seem identical, are available but that one is intended for clinical diagnosis while the other is intended for RUO. For example – “Applied Biosystems, QuantStudio 5 real-time PCR systems - A28570 (RUO)” vs “Applied Biosystems, QuantStudio 5 Dx Real-Time PCR System - A47326 (Clinical Diagnostics)”.

Under exceptional circumstances, these reagents and instruments can be procured for diagnostic procedures (e.g., when no commercial IVD device exists or when an existing IVD does not meet patient-specific clinical needs); however, this requires documented validated procedures which are implemented by authorized qualified personnel in an authorized laboratory.

UNDP COs must ensure that they obtain the correct product specifications which are aligned with the “intended use/purpose” for the items which need to be procured and, where items are classified as “RUO” that they get written confirmation from the Government that 1) the RUO products being requested will be used for the intended purpose (i.e., for research use only), or 2) the RUO products being requested will be used for diagnostic purposes. If the latter, the Government must clearly define and articulate the conditions under which the RUO products will be used for diagnostic purposes. In both cases, the information must be shared with the UNDP QA Team; the UNDP QA Team will acknowledge the communication and will stipulate that the end-user is fully responsible for any off-label use of these RUO products.

Where the RUO equipment(s) and/or reagents(s) are financed by the Global Fund, the Principal Recipient must confirm to the UNDP QA Team that the RUO equipment(s) and/or reagent(s) have been approved for the stated intended purpose by the Global Fund, and that it is included in the approved grant Health Product Management Template (HPMT).

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