Impact of emerging technologies and regulations on the role of POCT

Point-of-care testing (POCT) can be introduced by laboratory directors or c linicians 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 responsibil ity of the laboratory is less clear in many other places. When point-of-car e instrument technology and the intrinsic design of the device leads to dev ice-specific parameters or analytical differences from laboratory-based equ ipment, there is a risk of misinterpretation and erroneous treatment decisi ons. Laboratory staffs are more often aware of the interaction of analytica l technology and result interpretation than clinicians, making it more rati onal to involve the laboratory in the selection of point-of-care equipment, procedures, and therapeutic decisions based on the results. The design con trol and risk-analysis provisions of emerging regulations such as the EU in vitro diagnostic medical device (IVD) can be interpreted as engaging the m anufacturer's responsibility, even when the equipment is functioning accord ing to specification. This is especially hue of device-specific parameters in which cross-calibration or traceability to a reference material or metho d is not possible. This is a further argument for involvement of the labora tory in the selection and implementation of point-of-care testing devices. (C) 2001 Elsevier Science B.V. All rights reserved.