pointofcareTests

Point-of-care tests (POCT) are diagnostic tests performed at or near the site of patient care, designed to provide rapid results that support immediate clinical decisions. By operating outside traditional central laboratories, POCT can be conducted in clinics, emergency departments, ambulatory care centers, ambulances, and in patient homes or at the bedside. The aim is to shorten turnaround times and streamline patient management.

POCT covers a range of test methodologies, including immunoassays, molecular assays, and biosensor-based devices. Common examples include glucometers for blood glucose, rapid pregnancy tests, and rapid tests for infectious diseases such as strep A, influenza, HIV, and SARS-CoV-2 antigen tests, as well as point-of-care coagulation testing (INR), cardiac troponin, D-dimer, and lipid screening.

Advantages include quicker decision making, improved patient flow, reduced need for repeat visits, and expanded access in settings with limited laboratory infrastructure. Limitations include variable analytical performance across devices and tests, operator dependence, pre-analytic factors, and environmental influences. Quality assurance and ongoing training are essential, and regulations typically govern accuracy, calibration, and result reporting.

Regulatory frameworks vary by country. In the United States, POCT devices may be regulated under CLIA, with some tests designated as waived or requiring higher complexity safeguards. International standards such as ISO 22870 address POCT quality and competence, alongside ISO 15189 for medical laboratories. Effective POCT programs also require data management and device connectivity to electronic health records and robust quality assurance.

Overall, POCT is a valuable tool when appropriately validated and integrated into clinical workflows.