POINT-OF-CARE TESTING TECHNOLOGY

Point-of-care (POC) testing represents the fastest growing yet most co ntroversial sector of diagnostic testing. The technologies implemented to date for POC testing have been in response to the clinical practit ioner's demand for speed while maintaining analytical performance. Imp rovements to enhance speed have included miniaturization of sensors, t he use of solid state reagents in unique matrices, production of preci sion plastic disposables and incorporation of high speed and high capa city microprocessors. As concerns by laboratory medicine professionals were raised over the need for satisfactory quality control, safeguard s have also been configured into POC testing devices. These safeguards have included the use of communication links between POC test sites a nd the central laboratory, high capacity data storage devices, and in situ icon driven training routines. In addition, test specific informa tion and assay lot calibration data are now frequently encoded and pro vided with each test in a mar;ner that links the manufacturer's qualit y control of individual test lots to each specific testing event. With over 50 commercial entries vying for a share of the POC market, some very innovative instrumented and non-instrumented systems have been de veloped. Systems are now available that allow an end user, with a mini mum of training and background, to obtain results equal to those of th e central laboratory. However, processes and procedures need to be put in place to ensure that the POC test user is obtaining valid results and high quality. Since these procedures are already in place in the c entral laboratory, the appropriate site for administration of POC test ing is the central laboratory. With the central laboratory taking resp onsibility for training, system calibration, documentation and quality control, POC testing could continue to grow in a controlled manner. I n an environment, which we term controlled independence, quality would be assured by laboratory medicine professionals, while speedy results would be delivered by POC users. The development of wireless communic ation links between the POC systems and the central laboratory is one mechanism to achieve this controlled independence.