Bayer HealthCare Ascensia BREEZE and Ascensia AUTODISCTM Unique 10-Test Disc - Manual (Page 40)

Weighted Deming Agreement Statistics / Pearson correlation
2. Professional / Lay User Evaluation: A patient use
evaluation was conducted at two diabetes clinics. Lay users
with diabetes learned to use the meter system by reviewing
the meter user guide. After reviewing the instructions, the
users performed fingersticks and glucose assays using the
Ascensia
® B REEZE ™ System. Two test strip lots were
evaluated, one at each of the two clinics. After the user’s
self test, the attending healthcare professional performed
an Ascensia
® B REEZE ™ System assay from the lay user’s
fingerstick. A capillary blood sample was then collected for
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0
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20
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35
0 5 10 15 20 25 30 35
y=x
Ascensia
®
B
REEZE
™ Plasma Glucose (mmol/L)
YSI Plasma Glucose (mmol/L)
95% Confidence Interval
N Y= Slope / Intercept R
204 1.07x – 0.21 1.03 to 1.10 –0.48 to 0.06 0.983