~Minimum accuracy requirements of ISO15197: 2013 Section 6.3 standard require ≥95% of the measured values to fall within ±0.83 mmol/L at glucose concentrations <5.5 mmol/L or within ±15% ≥5.5 mmol/L of the referenced method.
† An ad hoc analysis demonstrated that 95% of the results were within the error range ±0.3 mmol/L or ±5.3% of the laboratory reference values for glucose concentrations <5.5 mmol/L or ≥5.5 mmol/L, respectively.
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