Orphee mythic 22 - 4. SPECIFICATIONS; 4.1 ANALYTICAL SPECIFICATIONS

REF : M22/UM/EN/014
3. INSTRUMENT SET UP
MYTHIC 22
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Page 35/105
4. SPECIFICATIONS
4.1 ANALYTICAL SPECIFICATIONS
Throughput: > 45 samples/hour
Sample Volume: 15,7 µl
Measurement Principle: WBC/RBC/PLT: Impedance
Five part diff: Optical flow cytometry
Hemoglobin: Spectrophotometry at 555 nm
Hematocrit: Volume integration
Linearity:
Linearity is measured with linearity sample performed four times for each level.
PARAMETERS
RANGE
LIMITS (the larger)
WBC (10
3
/mm
3
)
0 to 100
+/- 0,4 or +/- 4%
RBC (10
6
/mm
3
)
0,1 to 8
+/- 0,07 or +/- 3%
HGB (g/dL)
0,5 to 24
+/- 0,3 or +/- 2%
HCT (%)
5 to 70
+/- 2 or +/- 3%
PLT (10
3
/mm
3
)
5 to 2 000
+/- 10 or +/- 5%
Reportable range:
Within the reportable range, the results are flagged with a D to indicate that it is necessary to re-dilute
and re-run the sample.
PARAMETERS
REPORTABLE RANGE
WBC (10
3
/mm
3
)
100 to 150
RBC (10
6
/mm
3
)
8 to 15
HCT (%)
70 to 80
PLT (10
3
/mm
3
)
2000 to 5 000
Repeatability:
Calculated with 20 runs of a fresh whole blood sample performed on a commercial MYTHIC 22.
PARAMETERS
Coefficient Variation
RANGE
WBC
< 2,5%
> to 6,0×10
3
/mm
3
LYM
< 5%
> to 15 %
MON
< 10%
> to 7 %
NEU
< 4%
> to 50 %
EOS
< 10%
> to 5%
BAS
< 40%
> to 2%
RBC
< 2%
> to 4,0
×
10
6
/mm
3
HGB
< 1,5%
> to 12,0 g/dL
HCT
< 2%
> to 40,0 %
MCV
< 1%
> to 85 fL
RDWC
< 4%
> to 14
PLT
< 5%
> to 250×10
3
/mm
3
MPV
< 3%
> to 8 fL
Calculated method: CV = SD
X
Σx²- (Σx)²
SD = N
N - 1
Please note that this table gives the acceptable references of CV's used in calibration process