CLSI POCT5 A : 1ED 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PERFORMANCE METRICS FOR CONTINUOUS INTERSTITIAL GLUCOSE MONITORING
27-03-2023
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Point Accuracy
6 Trend Accuracy
7 Evaluating the Threshold Alarm
8 Device Stability
9 Calibration
10 Lag Time
11 Establishing Trueness of Measurement and Device Tracebility
References
Appendix A - Clinical Trials
Appendix B - R-Deviation - Numerical Accuracy Metric for Rate
of Change in Process Measurement
Appendix C - Continuous Glucose- Error Grid Analysis (CG-EGA)
- Metric fo CG-EGA
Summary of Delegate Comments and Committee Responses
The Quality Management System Approach
Related CLSI Reference Materials
Describes consensus guidelines for health care professionals, in vitro diagnostic (IVD) and medical device manufacturers, and regulatory agencies on how continuous glucose monitor (CGM) data should be: 1) presented; 2) compared between devices; and 3) compared between measurement technologies.
| DevelopmentNote |
Supersedes NCCLS POCT5 P. (01/2009)
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| DocumentType |
Miscellaneous Product
|
| PublisherName |
Clinical Laboratory Standards Institute
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| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| CLSI POCT6 : 1ED 2015 | EFFECTS OF DIFFERENT SAMPLE TYPES ON GLUCOSE MEASUREMENTS |
| CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
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