OPTi CCA-TS2, Руководство оператора, Страница: 247 / 299

Operator’s Manual – OPTI CCA-TS2 Glu-3
ANALYTES GLUCOSE
Reproducibility
Controls
Within run precision (S
wr
) and Total Precision (S
T
), were determined from 2 runs per day with 2 replicates
per run over a period of 10 days following the CLSI guideline EP5-A2. Typical results for 3 different
control levels are shown below:
Glucose (mg/dL) OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3
Days Run 10 10 10
Total Average 40.5 95.7 316.2
Within Run St. Dev. (S
wr
) 1.6 3.5 7.5
Within Run % CV 3.9% 3.6% 2.4%
Total Precision St. Dev. (S
T
) 2.4 4.4 9.4
Total % CV 5.9% 4.6% 3.0%
Whole Blood
Within-run precision in whole blood samples was evaluated at 3 different concentrations on the OPTI
CCA-TS2. The table below shows the Averages, Standard Deviations and % CV calculated from 10
samples for each level.
Glucose (mg/dL) Whole Blood
Level 1 Level 2 Level 3
Average 82.7 166.1 34.6
St. Dev 3.8 8.2 2.4
%CV 4.65% 4.91% 6.94%
n 10 10 10
Linearity
Wherever possible, linearity for the OPTI CCA measurement has been established against reference
materials or methods. Glucose linearity is established by measurement of gravimetrically prepared,
N.I.S.T. traceable aqueous standard solutions (Glucose
ST
). Glucose linearity in serum is by measurement
of N.I.S.T. Standard Reference Material 965 Glucose in Frozen Human Serum (Glucose
NIST
).
No changes were made to the Glucose sensor or the measurement principle, so the traceability of the
OPTI CCA-TS2 is equivalent to the OPTI CCA.
Correlation
Slope Intercept Correlation
Coefficient
Sy.x Range n
Glucose
ST
(mg/dL) 0.9874 3.26 0.9959 7.57 30 to 400 126
Glucose
ST
(mmol/L) 0.9874 0.181 0.9959 0.420 1.6 to 23.0 126
Glucose
NIST
(mg/dL) 1.0256 -7.79 0.9912 8.13 97 to 306 36
Glucose
NIST
(mmol/L) 1.0256 -0.432 0.9912 0.451 5.4 to 17.0 36