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Performance characteristics, Appendix d – ITC IRMA TruPoint Blood Analysis System User Manual

Page 153

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D.1

Appendix D

Performance
Characteristics

ACCURACY

Accuracy was determined by analyzing human whole blood samples on both
the IRMA TruPoint blood analysis system and a reference method. Least
squares analysis was used to determine the line-of-best-fit.

pH

Number of samples:

94

Range evaluated:

6.860 - 7.710

Slope:

0.936

Intercept:

0.456

Correlation Coefficient (r):

0.997

Sy.x:

0.017

pCO

2

Number of samples:

94

Range evaluated (mmHg):

4.4 - 149.4

Slope:

0.972

Intercept:

0.308

Correlation Coefficient (r):

0.999

Sy.x:

1.88

pO

2

Number of samples:

94

Range evaluated (mmHg):

17.9 - 356.5

Slope:

0.996

Intercept:

1.494

Correlation Coefficient (r):

0.999

Sy.x:

2.91

Sodium (Na+)

Number of samples:

137

Range evaluated (mM):

86.0 - 168.0

Slope:

1.110

Intercept:

-22.71

Correlation Coefficient (r):

0.998

Sy.x:

2.14