Diabetes Care

Topic: How do you check your meter’s performance?

How do you check your meter’s performance?

There are two steps to assess if your meter works accurately:

Step 1. Bring you home glucometer to the hospital
You’re suggested to test the fasting plasma glucose level via the medial biochemistry analyzer in hospitals, and take the biochemistry analyzer as the criterion to see the how much difference between the results from the biochemistry analyzer and the home glucometer. 

Step 2. Compare test results (home meter vs. bio-analyzer) 
According to the system accuracy standards of 2013 (ISO: 15197:2013), 95% of blood glucose test results must be:

  • Within ± 15 mg/dL(0.8mmol/L) of laboratory results at concentrations < 100mg/dL(5.6mmol/L).
  • Within ± 15 % of laboratory results at concentrations ≧100mg/dL(5.6mmol/L).

If those values can’t meet the accuracy requirement, then it may indicate some accuracy issue in your blood glucose meter, test strips, or monitoring technique.

In other words, if your fasting plasma glucose value tested from the biochemistry analyzer is 154mg/dL(8.6mmol/L), then the acceptable bias should be limited from 137mg/dL(7.6mmol/L) to 177mg/dL(9.8mmol/L). If the blood glucose tested from your home glucometer falls within this range, e.g., 138mg/dL(7.7mmol/L), it means that your meter works accurately based on ISO15197: 2013 standard.

Last but not least – don’t make this mistake
Do NOT compare your meter to other home meters! From professional quality control perspective, the medical-level (or laboratory-level) biochemistry analyzer is the sole standard to compare with.

Source: ISO 15197:2013 version

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