OPTIMedical OPTI CCA-TS, Operator'S Manual, Page: 196 / 271

PO2-2 Operator’s Manual – OPTI CCA-TS
P
O
2
ANALYTES
Reproducibility
Typical Within-Run ( Swr ), Between-Day ( Sdd ) and Total ( ST ) Precision is determined from 1 run per
day with 2 replicates per run for 20 days on each of two OPTI CCA instruments.
P
O
2
is expressed in
mmHg.
Material mean S
wr (CV%)
S
dd (CV%)
S
T (CV%)
OPTI CHECK PLUS
(aqueous control solution)
Level 1 68.9 0.13 (0.2) 0.59 (0.9) 0.61 (0.9)
Level 2 100.6 0.09 (0.1) 0.87 (0.9) 0.87 (0.9)
Level 3 142.7 0.13 (0.1) 1.37 (1.0) 1.38 (1.0)
Serum 92.2 0.08 (0.1) 0.72 (0.8) 0.73 (0.8)
Reduced Bovine Hemoglobin 83.1 0.15 (0.2) 0.61 (0.7) 0.63 (0.8)
Solution
All specific performance characteristics tests were run with default instrument calibration and after
normal recommended equipment quality control checks were performed (see Operator’s Manual).
Specimens at each level were analyzed in replicates of two for 20 days. The within-run and
between-day standard deviations were calculated by the analysis of variance method.
Precision and Recovery on Whole Blood
Whole blood was tonometered at 37 °C to various levels of gravimetrically prepared gases with O
2
concentrations certified to 0.03% absolute by the manufacturer. For each tonometered level,
3 replicates were run on each of three OPTI CCA systems. All values are in mmHg.
Expected n Observed Swr bias %Recovery
20.8 7 21.2 0.97 0.4 102 %
41.5 7 39.9 1.03 -1.6 96 %
48.6 7 50.0 0.84 1.4 103 %
75.4 7 75.1 1.04 -0.3 100 %
120.4 9 121.2 2.06 0.8 101 %
201.3 8 206.3 2.67 5.0 102 %
300.5 9 296.8 4.91 -3.7 99 %
489.4 7 489.5 12.92 0.1 100 %
499.5 7 485.9 16.22 -13.6 97 %