BACKGROUND: A key approach in enabling people with diabetes to better manage their condition is through self-monitoring of blood glucose (SMBG). Any functional SMBG system should demonstrate clinical accuracy across a broad glucose range and be insensitive to hematocrit. Furthermore, it should be incumbent on the manufacturer to demonstrate that their product continues to meet clinical accuracy claims during product lifetime.METHODS: Test strips from a globally distributed SMBG product were sampled from randomly selected production batches as part of the manufacturer's routine product evaluation process. Clinical accuracy was assessed within diabetes patients at 3 clinic sites against a standard reference method and evaluated against system accuracy in accordance with the ISO 15197:2015 standard (unchanged from ISO 15197:2013 in terms of performance specifications). Data were collected over 7 years (2010-2016) and comprised 73,600 individual glucose results. Overall clinic performance was assessed, as was accuracy at low and high glucose levels and extremes of hematocrit.RESULTS: Across the 7-year surveillance period, overall test strip clinical accuracy was 97.8% versus the 95% ISO-defined minimum criterion with by-year values of 97.0-98.6%. Accuracy at the lowest (?50 mg/dL) and highest (>400 mg/dL) ranges of glucose was 97.0% and 98.3% respectively. Within these low/high blood glucose subpopulations, accuracy at the lower and upper first percentile hematocrit ranges, was 98.9%, and 97.1% respectively.CONCLUSIONS: This 7-year surveillance program showed the test strips to have excellent clinical accuracy at the outer ranges of subject blood glucose and hematocrit, based on assessment against the ISO 15197:2015 clinical accuracy criterion.
Biomarkers Blood Glucose