Clinical and Laboratory Standards Institute document POCT06—Effects of Different Sample Types on Glucose Measurements provides information to assist the clinical and point-of-care staff in understanding the potential impact of the use of different sample types on results and measurement procedure comparisons of glucose test systems. The information includes preexamination, examination, and physiological considerations. This report will help clinicians understand how to better design evaluation protocols for technology or devices under consideration. Use of this report by clinicians will also help ensure that even those who adopt new technologies early will do so with the knowledge that ensures patient safety. Use of this report by manufacturers will help ensure they can meet and understand customer requirements in their product design for glucose testing systems. The impacts of sample type, test methodology, calibration, sample transportation or delay in testing, and frequency are reviewed. The influence of metabolic changes was minimally addressed in CLSI document POCT121 and will be expanded upon here in order to help clinicians understand how to decide if metabolic changes are influencing result variances noted in a comparison.

This report is designed to help clinicians, system evaluators, regulators, and manufacturers understand the influence of various parameters on glucose test result comparisons and to understand the clinical challenges that exist when glucose methodologies, sample types, and user techniques differ. This report is intended to help discern whether or not a difference between glucose results is caused by 1) the test measurement procedure(s), 2) patient-specific interferences, 3) the protocol, or 4) by some combination of these factors. It also includes consideration for sample type, fluid compartments, physiology, and calibration of the devices. The intended users of this report are clinicians, point-of-care teams, pathologists, laboratory directors, and manufacturers of glucose testing devices. The information will help users to understand the clinical challenges that exist within the continuum of care when glucose is measured using different methodologies and sample types. This report is not intended to be used for measurement procedure validation of new technologies.