OPTi CCA-TS2 User Manual

Operator’s Manual – OPTI CCA-TS2 Ca-3
ANALYTES CALCIUM
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 dif
ferent
control levels are shown below:
Ca
++
(mmol/L) OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3
Days Run 20 20 20
Total Average 1.57 1.27 0.79
Within Run St. Dev. (S
wr
) 0.01 0.01 0.01
Within Run % CV 0.9% 0.7% 0.9%
Total Precision St. Dev. (S
T
) 0.02 0.01 0.01
Total % CV 1.5% 1.0% 1.5%
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.
Ca
++
(mmol/L) Whole Blood
Level 1 Level 2 Level 3
Average 1.21 2.58 0.82
St. Dev 0.004 0.010 0.005
%CV 0.35% 0.40% 0.59%
n 10 10 10
Linearity
Wherever possible, linearity for the OPTI CCA measurement has been established against reference
materials or methods. Ionized Calcium linearity is established by measurement of gravimetrically
prepared, N.I.S.T. traceable aqueous standard solutions (Ionized Calcium
ST
) and by measurement of
N.I.S.T. Standard Reference Material 956a Electrolytes in Human Serum (Ionized Calcium
NIST
).
No changes were made to the Ionized Calcium sensor or the measurement principle, so the traceability of
the OPTI CCA-TS2 is equivalent to the OPTI CCA.
Correlation
Slope Intercept Correlation
Coefcient
Sy.x Range n
ionized Calcium
ST
1.0022 -0.0025 0.99983 0.017 0.2 to 3.0 24
ionized Calcium
NIST
0.9938 0.0081 0.99843 0.016 1.07 to 1.71 12

OPTi CCA-TS2 Specifications

General

Brand	OPTi
Model	CCA-TS2
Category	Measuring Instruments
Language	English