Evaluating a Novel Ex Vivo Point-of-Care Testing Device or Blood Gas and Electrolyte Measurement for Acceptance by the Point-of-Care Testing Committee

This article describes the complex processes encountered by a point-of-care testing (POCT) committee evaluating a novel ex vivo device for measuring blood gases, potassium, and hematocrit that would be of value in the monitoring of patients in critical care, enabling regular monitoring without the requirement for blood loss using existing point-of-care devices. With many important potential advantages to clinical management including a significant reduction in preanalytical errors and blood loss, it, however, cannot be compared directly with an existing analytical process in the laboratory. Although without an option for running external quality control samples (infection risk), internal quality control monitoring is manageable. The article includes a description of how the manufacturers manage calibration and monitoring of the device performance. Importantly, there is a recalibration schedule and also the possibility to challenge the system with control solutions. There is a reflection on the RILI-BAEK quality requirements for laboratories, where the performance with respect to the manufacturers' own control solutions, together with error flags and the use of percentage root mean SDs that are graded for such parameters as blood gases and electrolytes, sets an example of a system that would be likely to satisfy the POCT committee, similar to that used for indwelling analyzers (eg, continuous glucose monitoring devices). It includes aspects of how this device would meet the st...
Source: Point of Care: The Journal of Near-Patient Testing and Technology - Category: Pathology Tags: Original Articles Source Type: research