There is an urgent need for a change in the law, backed up with Medicines and Healthcare products Regulatory Agency (MHRA) regulation, for many DIY diagnostic tests, says Dr Martin Myers, Consultant Clinical Biochemist, Joint Clinical Lead at NHSE Getting it Right First Time (GIRFT), Pathology. Laboratory Director Clinical Biochemistry & Clinical Lead for POCT at Lancashire Teaching Hospital.
This needs a risk-based framework, where some DIY tests should be withdrawn from the high street. Inaccurate, self-bought, self-testing point-of-care (POC) diagnostic tests can overburden the NHS and cause unnecessary concern to the patient with false positives; and false re-assurance to the patient with false negatives.
We urgently need to triangulate legislation, regulation and NHS Point-of-Care Strategy. The GIRFT POCT Quality Wheel can support such an integrated approach.
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