NIPRO Diagnostics True balance - Performance Characteristics; Accuracy (ISO 15197: 2003 data); Precision (ISO 15197: 2003 data)

Performance Characteristics
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Accuracy (ISO 15197: 2003 data)
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Diabetes experts have suggested that glucose meters should
agree within 0.83 mmol/L (15 mg/dL) of a laboratory method
when the glucose concentration is less than 4.2 mmol/L (75
mg/dL), and within 20% of a laboratory method when the
glucose concentration is 4.2 mmol/L (75 mg/dL) or higher.
The table below shows how often data were compared to
parallel results obtained on a reference instrument (Super GL).
Finger Sample - <4.2 mmol/L (75 mg/dL)
Finger Sample - >
4.2 mmol/L (75 mg/dL)
Slope 1.01 y-intercept -0.16 mmol/L (-2.83 mg/dL)
r
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0.97 Range 1.1-33.3 mmol/L (20 - 600 mg/dL)
Total points within limits: 193/200 = 96.5%
Precision (ISO 15197: 2003 data)
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Precision describes the variation between TRUEbalance
results. Precision studies were performed in a laboratory.
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±0.3 mmol/L (5 mg/dL) 18/31 = 58%
±0.6 mmol/L (10 mg/dL) 25/31 = 81%
±0.8 mmol/L (15 mg/dL) 29/31 = 94%
±5% 64/169 = 38%
±10% 120/169 = 71%
±15% 146/169 = 86%
±20% 164/169 = 97%
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