Point of care testing (POCT) in clinical trials is the rapid medical diagnostic testing at or near the place in which a patient resides, intended to help optimize patient care and reduce patient burden. The use of basic POCT in clinical trials, like pregnancy, glucose, and oxygen concentration, is in regular use by investigators and patients.
Growth in the Use of Complex Devices
More complex POCT has gained traction in clinical trials. For example, devices have been deployed at investigator sites to screen and enroll a patient in a single visit helping to reduce screen failure rates via a pre-screening step and providing for results more rapidly than local labs. POCT devices can be connected directly to clinical trial laboratory systems, enabling visibility of POCT device laboratory reports and alerts to study teams and centralized data transfers.
Complex POCT Devices
The following includes examples of the kind of testing available via POCT devices: Hematology, chemistry, coagulation, lipids, influenza, blood gases, electrolytes, metabolites, cholesterol, glucose, triglycerides, and lactate.
Product development and regulatory activities occur with high frequency in this space, so please inquire regarding specific testing. Consultation with medical and regulatory professionals is required to assure that devices and tests align with local jurisdiction regulatory guidelines, and that operators and investigators maintain the necessary capabilities and licensure.
Through our partners, Q2 Solutions provides a menu of services, or a turnkey approach, for POCT at investigator sites including:
- Protocol consultation
- Device sourcing
- Rental and purchase of devices
- Logistics for deployment and return of devices
- Reagent supply and management
- Device integration with clinical trial laboratory systems
- Investigator training and support
- Return and/or destruction of devices
For more information regarding POCT, and our lessons learned, please read our Point of Care Testing article in Applied Clinical Trials.