OPTIMedical OPTI CCA-TS - Page 230

Lac-4 Operator’s Manual – OPTI CCA-TS
LACTATE ANALYTES
Linearity
2
Wherever possible, linearity for the OPTI CCA-TS measurement has been established against reference
materials or methods. Linearity for the measurement of Lactate has been established versus the
gravimetric concentration of lactate in a dilution sequence of aqueous buffers following CLSI guideline
EP6-A.
Correlation
 Slope Intercept Coefcient(R
2
) Sy.x Range n
0.93 -0.08 0.993 0.47 0.3 – 17.5 107
Linearity was also established versus the I-STAT analyzer using whole blood samples that had been
spiked with lactic acid to cover the measurement range.
Correlation
 Slope Intercept Coefcient(R
2
) Sy.x Range n
1.00 0.00 0.978 0.67 1.06 - 16.91 405
Correlation to Other Methods
2
OPTICCA-TSvsotherLactateInstrumentsonwholebloodinatypicalsetting
Lactate analysis of heparinized whole blood samples was performed at multiple clinical sites. Samples
were analyzed on the OPTI CCA-TS in parallel with laboratory instrumentation operated by hospital
personnel and controlled following the hospital’s established procedures.
Correlation
ComparativeMethod* Slope Intercept Coefcient(R
2
) Sy.x Range n
Analyzer A 0.96 -0.01 0.944 0.64 0.78 - 13.96 175
Analyzer B 1.18 -0.54 0.952 0.55 0.40 - 11.3 49
* For more information on specic analyzers used, please contact OPTI Medical Technical Support.
References
1. Tietz. (2006). Clinical Chemistry and Molecular Diagnostics (4th Edition ed.). (C. A. Burtis, E. R.
Ashwood, & D. E. Burns, Eds.) St. Louis, Missouri: Elseview Saunders.
2. OPTI Medical. Model equation for regression statistics is: [results of OPTI Analyzer] = slope(m)
[comparative method results] + intercept(b).