Siemens ADVIA 2120, Руководство оператора, Страница: 372 / 477

Regulatory Information 9-31
The following Regression statistics were computed using a protocol similar to
that recommended in the NCCLS document EP9-A,
Method Comparison and
Bias Estimation Using Patient Samples
; Approved Guideline (1995).
Parameter Comparative System
or Method Regression
Equation (y=)
r Sy.x
WBC (10³/µL) Technicon H •
3 RTC
1.06x - 0.74 0.997 1.42
RBC (10
6
/µL) Technicon H
•
3 RTC
0.98x + 0.11 0.997 0.07
HGB (g/dL)
Technicon H
•
3 RTC
1.01x - 0.2 0.997 0.2
MCV (fL)
Technicon H
•
3 RTC
0.90x + 9.6 0.994 1.1
CH (pg)
Technicon H
•
3 RTC
1.00x + 1.2 0.990 0.6
CHCM (g/dL) Technicon H
•
3 RTC
1.17x - 6.5 0.974 0.5
RDW (%)
Technicon H
•
3 RTC
0.86x + 1.3 0.980 0.6
HDW (g/dL)
Technicon H
•
3 RTC
0.98x + 0.06 0.959 0.13
PLT (10³/µL) Technicon H
•
3 RTC
1.08x - 2.0 0.991 27
MPV (fL)
Technicon H
•
3 RTC
0.76x + 0.9 0.925 0.4
x = Technicon H
•
3 RTC system
y = ADVIA 120 Hematology system
Performance Characteristics: Carryover
Sample carryover for the ADVIA 120 Hematology System was measured for
WBC, RBC, HGB, and PLT. The performance specification for carryover is
≤
1% for all parameters.
Carryover was evaluated on the ADVIA 120 Hematology System by the
aspiration of a high pool prepared for linearity testing, followed by 3 aspirations
of cell-free plasma. Percent carryover was calculated as:
% Carryover = [(L
1
- L
3
) / H] x 100
L
1
= the count for the first aspiration of cell-free plasma
L
3
= the count for the third aspiration of cell-free plasma
H = the count from the high pool
The following results were obtained:
Parameter Observed Carryover
WBC 0.4%
RBC 0.2%
HGB 0.2%