Point-of-care molecular testing gains ground outside the laboratory

Molecular testing at the point of care has moved past the pilot stage in several European health systems. Cartridge platforms that return a result in under thirty minutes are now used in emergency departments for respiratory panels and in outpatient clinics for sexually transmitted infections, where a same-visit result changes management immediately. The clinical argument is strongest where the result determines isolation or antibiotic decisions.

The limiting factor is rarely the instrument. Connectivity to the laboratory information system, result documentation in the patient record, and quality control outside a controlled laboratory environment are the practical obstacles. Sites that solved these report far higher utilisation than those running the device as a standalone unit, where results are frequently re-entered by hand or never documented in a structured field.

Cost per test remains the main objection from laboratory medicine, which argues that centralised platforms achieve better economies at volume. Point-of-care advocates counter that the relevant comparison includes the cost of a follow-up visit and of empirical treatment started while a result is pending. The argument usually resolves at the level of a local business case rather than through a national policy decision.

Regulatory classification varies by intended use, and a platform that reports a quantitative result for a critical marker faces a heavier evidence burden than one that reports a qualitative detection. Suppliers are therefore sequencing their menu expansion towards assays with simpler claims, and using the resulting installed base to support the clinical studies needed for higher-risk tests later in the roadmap.