Impact of emerging technologies and regulations on the role of POCT

Point-of-care testing (POCT) can be introduced by laboratory directors or clinicians in response to the need for rapid results to guide treatment. The professional responsibility for ensuring reliable and accurate results is well-defined in some countries such as France, but the role and responsibility of the laboratory is less clear in many other places. When point-of-care instrument technology and the intrinsic design of the device leads to device-specific parameters or analytical differences from laboratory-based equipment, there is a risk of misinterpretation and erroneous treatment decisions. Laboratory staffs are more often aware of the interaction of analytical technology and result interpretation than clinicians, making it more rational to involve the laboratory in the selection of point-of-care equipment, procedures, and therapeutic decisions based on the results. The design control and risk-analysis provisions of emerging regulations such as the EU in vitro diagnostic medical device (IVD) can be interpreted as engaging the manufacturer's responsibility, even when the equipment is functioning according to specification. This is especially true of device-specific parameters in which cross-calibration or traceability to a reference material or method is not possible. This is a further argument for involvement of the laboratory in the selection and implementation of point-of-care testing devices.