CLSI POCT05-A

Clinical and Laboratory Standards Institute document POCT05-A–Performance Metrics for Continuous Interstitial GlucoseMonitoring; Approved Guideline provides a consensus for health care professionals, in vitro diagnostic (IVD) and medical devicemanufacturers, and regulatory agencies on how continuous glucose monitor (CGM) data should be: 1) presented; 2) comparedbetween devices; and 3) compared between measurement technologies. Terminology is defined for measuring interstitial fluidglucose levels and comparing them to blood glucose levels. The degree of agreement for acceptable technical performance isdefined to assess method comparability. This guideline also presents methods for testing CGM performance and interpretingCGM levels. This guideline covers CGM point accuracy and trend accuracy, as well as CGM measurement sensitivity andspecificity. The guideline covers device instability due to changes in sensitivity over time. The guideline covers analytical andclinical metrics for establishing the calibration process. It covers approaches for accounting for lag time, which consists ofphysiologic lag plus process delay. Finally, for CGM measurements, the guideline covers how to use reference materials andestablish traceability to a reference system.

Published:

12/01/2008

ISBN(s):

1562386859

Number of Pages:

72