NIPRO Diagnostics TRUEyou - Technical Information; Performance Characteristics

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Performance Characteristics
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Precision: Precision describes the variation between results. ere are
two types of precision results measured, repeatability (using blood) and
intermediate precision (using control solution).
Repeatability: N=100
Mean (mmol/L) 3.4 5.1 8.5 12.1 19.2
SD (mmol/L) 0.11 0.14 0.27 0.37 0.66
%CV 3.2 2.9 3.1 3.0 3.4
Intermediate Precision: N=100
Mean (mmol/L) 3.1 7.6 19.5
SD (mmol/L) 0.09 0.24 0.69
%CV 3.1 3.2 3.5
System Accuracy: Diabetes experts have suggested that 95% of glucose
meter results should agree within + 0.83 mmol/L of the medical laboratory
values at glucose concentrations below 5.55 mmol/L and within + 15%
of the medical laboratory values at glucose concentrations at or above
5.55 mmol/L.
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e tables below show how oen healthcare professionals
(HCP) and users achieve these goals using capillary fingertip and forearm
blood samples when glucose results are not fluctuating. e laboratory
reference instrument is the Yellow Springs Instrument (YSI) Model 2300.
Tyou_OB_Guts_E4GBY03FDr20.indd 40 11/8/13 1:43 PM