Siemens ADVIA 2120, Руководство оператора, Страница: 384 / 477

Regulatory Information 9-43
Parameter Manual
Mean ADVIA 120
Mean t-test
p-value % Within
Binomial Limit
% MN 72.7 72.2 0.992 100%
% PMN 26.9 25.6 0.800 100%
% Neut 26.6 22.3 0.383 98%
% Lymph 63.2 54.6 0.088 96%
% Mono 9.5 17.6 0.15 96%
Performance Characteristics: Carryover
Because of the low number of cells counted in CSF analysis, the ADVIA 120
hydraulic cycles were designed to eliminate carryover when assaying CSF
samples. Prior to assaying each CSF sample, the ADVIA120 rinses all reagent
and sample pathways in preparation for the next sample. Carryover for the CSF
Assay was evaluated by measuring multiple assays of a highly cellular sample
followed by a low cellular sample. The observed carryover was less than 1%,
where carryover is expressed as the average percentage of the high level sample
that is lost to the trailing low level sample.
Performance Characteristics: Analytical Range
The analytical range for CSF WBC and RBC counts was established by making
serial dilutions of samples prepared to have low analyte values. The dilution
studies show that the CSF WBC count is accurate to 5 cells/
μ
L over the range
0–50 cells/
μ
L and accurate to 10% over the range 50–5,000 cells/
μ
L. The CSF
RBC count is accurate to 5 cells/
μ
L over the range 0–50 cells/
μ
L and accurate to
10% over the range 50-2880 cells/
μ
L. The results from the study are found in the
tables below.
CSF WBC Low Level Linearity
Pool
(% of reference level) Observed
WBC Expected
WBC Absolute
Deviation %
Deviation
0.00% 0 0 0
0.05% 2 3 -1
0.1% 5 5 0
0.2% 10 10 0
1.0% 53 50 3
10.0% 514 501 13 3
100% (reference level) 5009 5009 0 0