Medonic M16C-US, Руководство пользователя

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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