OPTIMedical OPTI CCA-TS, Operator'S Manual, Page: 230 / 271

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 Coefficient (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 Coefficient (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 Coefficient (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 specific 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).