OPTIMedical OPTI CCA-TS - Page 201

Operator’s Manual – OPTI CCA-TS PO2-B-3
ANALYTES PO
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 72 1.25 1.38 1.07 1.10 0.69 0.75
Level 2 109 1.73 1.97 1.77 2.04 1.36 1.63
Level 3 155 1.48 1.89 1.76 2.19 1.31 1.69
Whole Blood
Within-Run precision in whole blood samples was evaluated at three different PO
2
concentrations using
multiple instruments and multiple cassette lots.
PO
2
in Whole Blood
Level 1 Level 2 Level 3
Average 48.4 83.3 398.8
St. Dev 1.5 2.7 13.6
%CV 3.1% 6.0% 3.4%
n 18 18 18
Linearity
4
The linearity of the dry PO
2
sensor was established using whole blood samples tonometered with different
gas mixtures of known gravimetric compositon. The reference PO
2
values of the tonometered blood
samples were calculated from the gas composition using the following equation:
PO
2
= (Barometric Pressure – 47) * %O
2
LinearityofWholeBloodSamples
 Slope Intercept R
2
 Sy.x  Range  n
0.98 4.00 0.998 8.05 7 - 701 191