Instrumentation for Point of Care Testing

Posted by

SELECTBIO

Gary Thorpe, CEP Evaluation Centre, University of Birmingham

Abstract
Instrumentation for point of care (POC) testing must be designed to include a range features to ensure appropriate use and result generation. POC systems differ widely in complexity but can be handheld and relatively inexpensive. A wide range of instrumentation and testing systems are commercially available covering applications in diverse extra-laboratory situations, and based on numerous established or emerging technologies. Devices can produce a single result or a panel of multiple, simultaneous results which can be qualitative, semi-quantitative or fully quantitative, displayed by means including digital readouts, words or symbols. Several factors are critical for the application of technologies in routine POC testing and much can be learnt from the use of blood glucose meter systems which dominate the market. Irrespective of the complexity of technologies, systems should be simple, easy and intuitive to use with minimal training, portable, reliable, and robust; designed to minimise operator dependent steps such as timings, volume pipetting, sequential procedural steps, calibration/coding, and subjective determination of results and their interpretation. Systems should be based on conveniently stored, 'self contained' stable reagents, automatic processing of reactions and posses the ability to produce appropriate results which can be easily read, and data transferred by simple telecommunications technologies. Instrumentation should remove dependence on operators by ensuring operation of the system is foolproof, using error proof processes and failsafe devices including interlocking sequences, alarms and cut offs. Design can eliminate single points of failure and confirm correct operation of the device by means of sounds, screen feedback, countdowns, progress messages, prompts, preventative warnings and error codes. The instrumentation should also be capable of indicating if results are outside the systems analytical range, and detecting damaged, inappropriately stored or out of date reagents. In conclusion, with appropriately designed instrumentation, the introduction of new technologies and assays offers extremely exciting prospects and challenges for POC analytical systems.