horiba ABX MICROS ES60, Руководство пользователя

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ABX Micros ES60 OT/CT
2–10 User Manual - RAB237AEN
2.2. Precision (Repeatability)
◆
Based on 10 consecutive samplings from 1 fresh normal whole blood, without any alarms.
Tab.2-9 Precision (Repeatability)
Tab.2-10 Precision claims
2.3. Linearity
◆
Linearity range : the manufacturer's tested linearity zone of the instrument using linearity kits
and/or human blood.
◆
Linearity limits : maximum and minimum values within the instrument returns no dilution alarm.
◆
Visible range : range values given by the instrument. These values (above linearity limits) are
given as an indication. They are given associated with a "D" flag. This visible range is outside
manufacturer's range.
◆
Linearity kits : linearity was tested using available "Low Range" and "Full Range" linearity test kits.
The test kits were analyzed and data was computed according to the manufacturer's instructions.
◆
Human blood : linearity was also obtained on human blood, using a minimum of 5 dilution points.
The results of this study are as followed.
Tab.2-11 Linearity
Precision table: N=10
Parameters
ABX Micros ES60 OT ABX Micros ES60 CT
WBC 1.48% 1.65%
RBC 0.96% 1.19%
HGB 0.51% 1.00%
HCT 1.07% 1.38%
PLT 3.2% 3.23%
LYM % 2.23% 2.64%
MON % 4.67% 7.54%
GRA % 1.37% 1.42%
Precision table: N=10
Parameters
%CV Range
WBC <2.5%
4-10.0 x 10
3
/µl
RBC <2.0%
4-7 x 10
6
/µl
HGB <1.5% 12-18 g/dl
HCT <2.0% 36-54 %
PLT <5.0%
200-500 x 10
3
/µl
LYM % <10% 25-50%
MON % <20% 2-10%
GRA % <4% 50-87%
Parameters Linearity range Linearity limits Visible range
Error limit
(which ever is greater)
WBC (10
3
/mm
3
)
0.4 - 106.6 0 - 100 100 - 150 ±0.3 ±5%
RBC (10
6
/mm
3
)
0.2 - 8.1 0 - 8 8 - 18 ±0.07 ±3%
PLT (10
3
/mm
3
) ( A )
13 - 2777 0 - 2200 2200 - 6000 ±10 ±10%
PLT (10
3
/mm
3
) ( B )
13 - 4856 0 - 4000 4000 - 6000 ±10 ±10%
HGB (g/dl) 0.68 - 26 0 - 26* 26 - 30 ±0.3 ±3%
HCT (%) 2.0 - 80
0 - 55
56 - 80*
80 - 90
±2.0
±2.0 ±3%
±5%