Operator’s Manual – OPTI CCA-TS THB/SO2-3
Rapidly sedimenting blood samples should be mixed thoroughly and immediately aspirated into the OPTI
cassette, as described above in “Handling and Storage of Samples”, to ensure accurate tHb measurements.
If allowed to sediment, the blood sample’s reported tHb may be falsely high or low.
Fetal hemoglobin taken from cord blood extracts was tested and showed no interference to the tHb and
SO
2
measurement.
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. ctHb is expressed in g/
dL and SO
2 in %.
Material mean Swr (CV%) Sdd (CV%) ST (CV%)
OPTI CHECK PLUS Level 1 (ctHb) 19.7 0.009 (0.1) 0.049 (0.3) 0.05 (0.3)
(aqueous control solution) (SO2%) 77.8 0.03 (0.03) 0.13 (0.2) 0.13 (0.2)
OPTI CHECK PLUS Level 2 (ctHb) 14.2 0.02 (0.1) 0.07 (0.5) 0.08 (0.5)
(aqueous control solution) (SO
2%) 86.8 0.03 (0.1) 0.11 (0.1) 0.11 (0.1)
OPTI CHECK PLUS Level 3 (ctHb) 8.84 0.009 (0.1) 0.05 (0.5) 0.05 (0.6)
(aqueous control solution) (SO2%) 95.4 0.02 (0.1) 0.14 (0.1) 0.14 (0.2)
All specic 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.
Linearity
4
Wherever possible, linearity for the OPTI CCA measurement has been established against reference
materials or methods. Total hemoglobin content linearity is established by the photometric determination
of cyanmethemoglobin
.
5
No standard method exists for the measurement of oxygen saturation.
Correlation
Slope Intercept Coefcient Sy.x Range n
Total Hemoglobin 0.9839 0.165 0.99483 0.59 5.2 – 22.0 84
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