OPTIMedical OPTI CCA-TS - Page 205

Operator’s Manual – OPTI CCA-TS Na-3
ANALYTES SODIUM
All specic 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
3
Wherever possible, linearity for the OPTI CCA measurement has been established against reference
materials or methods. Sodium linearity is established by measurement of gravimetrically prepared,
N.I.S.T. traceable aqueous standard solutions (Sodium
ST
) and by measurement of N.I.S.T. Standard
Reference Material 956a Electrolytes in Human Serum (Sodium
NIST
)
Correlation
 Slope Intercept Coefcient Sy.x  Range  n
Sodium
ST
0.9788 2.456 0.99911 1.32 104 – 188 30
Sodium
NIST
1.0172 3.244 0.99957 0.55 121 – 161 18
Correlation to Other Methods
3
OPTICCAvsotherpH/BloodGasInstrumentsonwholebloodinatypicalsetting
Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional
and non-traditional operators of blood gas equipment in hospital laboratories. The blood was analyzed on
the OPTI CCA after obtaining the requisite results from existing instrumentation used for these analyses
and operated and controlled following their established procedures.
Correlation
ComparativeMethod* Slope Intercept Coefcient Sy.x Range n
Analyzer A (whole blood) 0.6500 50.15 0.7564 2.21 126 – 149 103
Analyzer B (whole blood) 0.9313 9.34 0.9180 1.95 129 – 156 173
Analyzer C (whole blood) 1.084 ± 0.226 -14.929 ± 3.176 0.9784 1.826 128 – 174 105
Analyzer D (whole blood) 1.080 ± 0.021 -6.382 ± 2.855 0.9678 2.007 117 – 163 174
Analyzer E (serum) 0.873 15.49 0.8911 1.77 128 – 149 68
Analyzer F (serum) 1.025 -4.57 0.9376 1.57 127 – 148 102
* For more information on specic analyzers used, please contact OPTI Medical Technical Support.
References
1. Tietz, Norbert W., Ed., Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W.B.Saunders,
Co., 1990) p. 436
.
2. Tsien R, New Calcium Indicators and Buffers with High Selectivity Against Magnesium and Protons,
Biochemistry 19, p.2396-2404, 1980
.
3. OPTI Medical. Model equation for regression statistics is: [results of OPTI Analyzer] = slope(m)
[comparative method results] + intercept(b).