TABLE 2

Accuracy of POC-CSF Glucose Analysis Relative to Current Standards for the POC Glucose Meter

POC Glucometer StandardAcceptable ErrorOur Study, %
Reference Glucose Level, mg/dLErrorPercentage of the Results, %
ISO 15197 (2013)<75Within ±15 mg/dL95100
>75Within ±20%95100
CLSI (2013)<100Within ±12 mg/dL95100
>100Within ±12.5%95100
<75>15 mg/dL<20
≥75>20%<20
FDA (2016)<75Within ±12 mg/dL95100
<75Within ±15 mg/dL98100
≥75Within ±12%95100
≥75Within ±15%98100