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NIPRO Diagnostics TRUEyou - Page 46

NIPRO Diagnostics TRUEyou
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44
100% of user TRUEyou forearm values fell within 0.83 mmol/L of the YSI results at
glucose levels < 5.55 mmol/L and within 15% at glucose levels > 5.55 mmol/L.
Forearm Samples (user vs. YSI) for glucose concentrations <5.55 mmol/L
Within + 0.28 mmol/L Within + 0.56 mmol/L Within + 0.83 mmol/L
16/28 (57%) 23/28 (82%) 28/28 (100%)
Forearm Samples (user vs. YSI) for glucose concentrations >5.55 mmol/L
Within + 5% Within + 10% Within + 15%
42/72 (58%) 61/72 (85%) 72/72 (100%)
Forearm Samples for glucose concentrations between 1.1-33.3 mmol/L
Within + 0.83 mmol/L or + 15%
100/100 (100%)
Parkes Error Grid: 100% of individual forearm glucose measured values
performed by the users fell within Zone A of the Parkes Error Grid (PEG).
User Performance Evaluation: A study evaluating glucose values from
fingertip capillary blood samples obtained by 100 lay persons showed the
following results: 100% within + 0.83 mmol/L of the medical laboratory values
at glucose concentrations below 5.55 mmol/L and 99% within + 15% of the
medical laboratory values at glucose concentrations at or above 5.55 mmol/L.
Tyou_OB_Guts_E4GBY03FDr20.indd 44 11/8/13 1:43 PM

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