Objective: To evaluate the analytical and clinical accuracy of glucose meter using International Organization for Standardization 15197 guideline.
Methods: A community based cross-sectional study was conducted in Kapan, Kathmandu, Nepal in October 2018. Glucose levels were measured using glucose meter and reference laboratory method among 203 adults after an overnight fasting and two hours of ingestion of 75 grams glucose. Paired t-tests and correlation analysis were done to compare the two methods. Modified Bland- Altman plots were created by incorporating ISO 15197 accuracy guidelines to compare the agreement between the two methods. Parks Error Grid analysis was used to evaluate the clinical accuracy.
Results: Mean of glucose meter readings were significantly higher than corresponding readings from reference laboratory method (p < 0.001) for both fasting and 2 hour (hr) conditions. Significant positive correlation was seen between the test results from obtained from the two methods. Modified Bland - Altman plots showed > 95% of the test results were beyond the acceptable analytical criteria of ISO 15197: 2003 & 2013. Park Error Grid-Analysis showed 99% of the data within zones A and B of the consensus error grid.
Conclusion: Glucose meter readings were within clinically acceptable parameters despite discrepancies on analytical merit. Possible sources of interferences must be avoided during the measurement to minimize the disparities and the values should be interpreted with caution.