Table 1.

Barriers and Opportunities to Introduction of Point-of-Care (POC) Diagnostic Tests to Low Resource Settings (LRSs)

Barriers	Impact on Supply	Impact on Demand	Opportunities
Ambiguous policy on use of diagnostics for clinical management	Undefined market opportunities and uncertainty in demand projections	The value proposition for adoption of a diagnostic test is undermined	Clearer policy guidelines with respect to diagnostic testing need to be established
Fragmented, unclear, and complex regulatory and registration processes at both international and national levels	Difficulty in mapping the most effective route to product registration when targeting to multicountry markets	In absence of clear international regulatory standards, procurers default to inappropriate regulatory standards	Where possible, regional regulatory and registration processes could be harmonized
Inconsistency between policy recommendations and regulatory standards	Leads to ambiguous product specifications and can lead to overdesigned, costly products	Leads to ambiguous criteria by which to evaluate technologies	Regulatory standards need to be harmonized with policy guidelines and publicized
Absence of robust and standard indicators/metrics to assess the impact of POC diagnostics tests beyond analytical performance	Challenge to demonstrate the value proposition for a POC product	No way of assessing the benefits of a new POC test when matched against central laboratory test	Investment is needed in fundamental operational research and modeling; local operational research capacity needs to be built
Inconsistency in purchasing practices from the donor community and national program	Leads to ambiguity in target price points and product specification trade-off decisions	Disenfranchises the end user (national laboratory systems) and patient as key stakeholders in defining product attributes and adoption decisions	Standards for assessment of impact and appropriateness of new POC technologies need to be developed and disseminated to key stakeholders
Poor definition of market opportunities	Challenging to define appropriate product profiles and specifications; disincentive to develop products specifically for LRS	A weak product pipeline, and products in the pipeline are often not appropriate for the end user; decision making for adoption of new technologies is poorly informed	Rigorous market intelligence needs to be collected and appropriately disseminated to key stakeholders
Undeveloped market environment	High uncertainty in timelines for product introduction and scale-up