Siemens ADVIA 2120, Руководство оператора, Страница: 402 / 477

Regulatory Information 9-61
Performance Characteristics: Imprecision
A total of 18 runs were performed using multiple samples.
The following estimates of imprecision were obtained by taking 25 aspirations
from each whole-blood sample. Each of the sample selectivity modes was tested
by sampling from opened tubes, and with the manual and automated closed-tube
samplers.
Parameter
Mean Standard
Deviation CV (%)
#RETIC (
10
9
/L) 57.8 7.7 13.3
%RETIC 1.2 0.16 13.3
CHr (pg) 28.9 0.2 0.7
Performance Characteristics: Correlation Data
The performance of the ADVIA 120 Hematology System was compared with the
performance of the Technicon H
•
3 RTC System (x) using whole blood from 60
normal donors and 70 hospital donors with each sample run in duplicate (n =
260).
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
#RETIC (
10
9
/L)
Technicon H
•
3 RTC 0.79x + 7.8
0.903 13.6
%RETIC
Technicon H
•
3 RTC 0.82x + 0.2
0.925 0.4
CHr (pg)
Technicon H
•
3 RTC 0.96x + 4.2
0.940 1.7
x = Technicon H
•
3 RTC system
y = ADVIA 120 Hematology system
Performance Characteristics: Carryover
Sample carryover for the ADVIA 2120/2120i Hematology System is expressed
as the percentage of a high-level sample lost to a trailing low-level sample.
Carryover was determined for the RBC count obtained from the reticulocyte
channel (RTC RBC).
Parameter Observed Carryover
RTC RBC 1.0%