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Research and evaluation


POCT capability is advancing rapidly, driven by the underlying technological trends of hardware miniaturisation and software improvement.

At the same time healthcare challenges spur efforts to reconsider how care is delivered, and POCT can potentially unlock new service models.

Not surprisingly the POCT arena has enormous scope for research and innovation. Members of the All Wales POCT Network contribute to test development and basic research through collaboration with university and industry partners.


POCT teams also have a very important role to play in independently assessing the diagnostic accuracy and clinical impact of new POCT platforms or tests.

Healthcare organisations have a duty to verify the performance claims of a POC test and ensure the test is acceptable for use in their particular clinical setting and patient population.

This can involve comparing POCT results to paired laboratory results for the same test. Increasingly however, newly developed POC tests have no laboratory counterpart (for example, pre-term labour biomarkers).

Evaluation may rely on retrospective analysis of the expected effect of the result on clinical decision making compared to the existing standard of care.


The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK.

MHRA is an executive agency, sponsored by the Department of Health. Alerts and Field Safety Notices issued by the MHRA may apply to POCT devices. These alerts can be found at

The MHRA operates a Yellow Card system in order to collect any reports of adverse incidents related to medicines or medical devices, including POCT devices at