Medonic M16C-US - Parameter Ranges

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11.3 Parameter Ranges
Linearity-Regression
and Linear Range
Linearity measured according to Boule I-1040 Section 8, based on Standard
EP6-A.
Parameter
Linearity-Regression (R
2
)
Linearity ±1%
WBC
≥ 0.99
0.5 – 80.0 x 10
9
/L
RBC
≥ 0.99
0.5 – 7.00 x 10
12
/L
PLT
≥ 0.99
30 – 1800 x 10
9
/L
HGB
≥ 0.99
2.0 – 23.0 g/dL
Displayed Range
Total range where results are reported, also outside of linearity range.
Parameter
Displayed range
WBC
0.0 - 119.9 x10
9
/L
RBC
0.00 – 14.00 x10
12
/L
MCV
15.0 – 250.0 fL
PLT
0 - 1999 x10
9
/L
HGB
0.0 – 35.0 g/dL
Correlation
Correlation was performed, using an Advia 120 and Medonic CA620 as
references. Data derived from 965 normal and abnormal fresh blood samples.
Parameter
Correlation Coefficients (R
2
), Advia/Medonic
WBC
≥ 0.98/ 0.98
RBC
≥ 0.97/ 0.98
MCV
≥ 0.98/ 0.99
PLT
≥ 0.98/ 0.99
HGB
≥ 1.00/ 1.00
Reproducibility
Measured as an average of 10 measurements each on 9 different vein K2-
EDTA collected normal samples, on 3 instruments, in OT, MPA, Cap Piercer,
and Autoloader modes.
Parameter
OT CV (%)
MPA CV (%)
WBC
7.0 x10
9
/L
1.8
2.5
RBC
4.59 x10
12
/L
0.9
1.5
MCV
86.8 fL
0.5
0.5
PLT
239 x10
9
/L
3.0
3.0
HGB
14.3 g/dL
0.8
1.3
Total System Precision
These values are reported from the specification for this system.
Parameter
Mode to Mode Comparison,
maximum difference OT to
Cap Piercer/Autoloader (%)
Repeatability n=10, single
series (%)
RBC
 2.5
 1.8
MCV
 2
 1.5
HGB
 2
 1.5
PLT
 7
 4.8
WBC
 5
 3.5