OPTi CCA-TS2, Руководство оператора, Страница: 223 / 299

Operator’s Manual – OPTI CCA-TS2 Na-3
ANALYTES SODIUM
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 20 days following the CLSI guideline EP5-A2. Typical results for 3 different
control levels are shown below:
Na
+
(mmol/L) OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3
Days Run 20 20 20
Total Average 126.1 143.7 156.5
Within Run St. Dev. (S
wr
) 0.6 0.7 0.4
Within Run % CV 0.4% 0.5% 0.3%
Total Precision St. Dev. (S
T
) 0.7 0.7 0.6
Total % CV 0.6% 0.5% 0.4%
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.
Na
+
(mmol/L) Whole Blood
Level 1 Level 2 Level 3
Average 136.5 167.4 112.7
St. Dev 0.4 0.2 0.4
%CV 0.26% 0.13% 0.33%
n 10 10 10
Linearity
Wherever possible, linearity for the OPTI CCA measurement has been established against reference
materials or methods. Sodium linearity is established by measurement of gravimetrically prepared,
N.I.S.T. traceable aqueous standard solutions (Sodium
ST
) and by measurement of N.I.S.T. Standard
Reference Material956a Electrolytes in Human Serum (Sodium
NIST
). No changes were made to the 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
Sodium
ST
0.9788 2.456 0.99911 1.32 104 to 188 30
Sodium
NIST
1.0172 3.244 0.99957 0.55 121 to 161 18