OPTIMedical OPTI CCA-TS, Operator'S Manual, Page: 193 / 271

Operator’s Manual – OPTI CCA-TS PCO2-B-3
ANALYTES
P
CO
2
(Dry Sensor)
Reproducibility
Controls
Within-Run (Swr) and Total (ST) Precision 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 three different lots of
B-Lac cassettes are shown below.
Material mean Lot 1 Lot 2 Lot 3
OPTI CHECK
(aqueous control solution)
Swr ST Swr ST Swr ST
Level 1 68 1.73 1.73 2.49 2.87 1.02 1.23
Level 2 42 0.44 0.51 1.11 1.20 0.45 0.59
Level 3 23 0.91 0.93 2.08 2.36 0.91 0.92
Whole Blood
Within-Run precision in whole blood samples was evaluated at three different P CO
2
concentrations using
multiple instruments and multiple cassette lots.
PCO
2
in Whole Blood
Level 1 Level 2 Level 3
Average 78.6 39.3 17.0
St. Dev 1.8 1.7 1.8
%CV 2.3% 4.4% 10.6%
n 18 18 18
Linearity
2
The linearity of the dry P CO
2
sensor was established using whole blood samples tonometered with
different gas mixtures of known gravimetric compositon. The reference
P
CO
2
values of the tonometered
blood samples were calculated from the gas composition using the following equation:
P CO
2
= (Barometric Pressure – 47) * %CO
2
Linearity of Whole Blood Samples
Slope Intercept R
2
Sy.x Range n
0.97 2.26 0.992 3.82 7 - 205 177