Previously submitted to: JMIR Diabetes (no longer under consideration since Sep 20, 2021)
Date Submitted: Sep 14, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Evaluating the influence of hematocrit: comparison of three POCT devices pursuant to ISO 15197 guidelines.
ABSTRACT
Background:
Maintaining normal blood glucose levels in diabetes therapy is fundamentally linked to precise and accurate blood glucose measurements. In the light of interfering quantities like various substances or hematocrit, these aspects are of utmost clinical importance within a standardized validation of blood glucose monitors for personal use as well as a continuous quality assessment.
Objective:
Continuous and independent quality assurance of aspects affecting a blood glucose monitoring system’s performance.
Methods:
The influence of the hematocrit on the performance of three blood glucose monitors was assessed in accordance with ISO 15197 and sponsor’s requirements.
Results:
Only one device showed acceptable deviations of ≤ 10 mg/dL / 10 % to the reference device across the entire range. The other devices showed minor to clinically relevant interferences, particularly in response to higher hematocrit values.
Conclusions:
Suitable BGM systems should be selected carefully by health care professionals and patients, especially with medical conditions known to interfere with blood glucose measurements.
Citation
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