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assay
Adults
Neonates
RBC (cells/L)
WBC (cells/L)
0-5
0 - 30
Lymphocytes (%)
60 20%
20 20%
Monocytes (%)
30 15%
70 20%
Neutrophils (%)
2 4%
4 4%
Lymphs/Monos (MNs)
Viral infections, multiple sclerosis, fungal infections,
CNS* syphilis, tuberculosis
Eos
Parasitic CNS* infestations
CSF Sample
Current Practice
WBC and RBC
Cell Counts
WBC
Differential
Chamber Count
2-10 min
Cytospin Sample
10-15 min
Repeat
Chamber Count
Patient CSF
Sample
CSF Reagent
Prepared Sample
Manual
Inspect
Sample
Chamber
Counts
High
WBC?
Cytospin
Slide
Stain
Slide
Dilute
Sample
Chamber
Counts
ADVIA
120
RBC
WBC
Diff
Review
Slide
RBC
WBC
Diff
30 - 45
min
ADVIA 120
Inspect
Sample
Prepare
Sample
5 - 10
min
Current Practice
CSF
Sample
WBC
Differential
r
o
b
a
L
l
Tota
Chamber Count
2-10 min
n
i
m
: 30
n
i
m
- 45
Cytospin Sample
10-15 min
Repeat Chamber
Count
Review Slide
5-15 min
Control kit:
1 vial each of 2 levels
sufficient for 10 tests/vial
Control kit:
2 Levels Low & High
1 vial each
10 tests/vial
10 day open stability
Kit Components
Running a Sample
CSF Screen
neuts
eos
Research Use Only
RBCs
noise
noise
Neut
Eos
Lymph
Eos
RBC
Manual
# WBC
# RBC
# Neuts
# Lymphs
# Monos
# PMN
# MN
Neutrophils
Lymphocytes
Monocytes
Eosinophils (currently for research use only, not reportable)
Reportable Results
Automated WBC on all samples
Automated RBC on samples < 1500 RBCs
cells/L
Differential, PMN and MN (absolute and %) on
samples with >20/L WBC
WBC Differential includes:
Neutrophils
Lymphocytes
Monocytes
Eosinophils (currently for research use)
Mono
Neut
Lymph
RBC
Eos
ADVIA 120
Manual
# WBC
94
95
# RBC
298
325
% Neuts
47
52
%Lymphs
34
44
%Monos
20
%PMN
47
48
% MN
53
52
Neut
Lymph
Eos
RBC
Manual
# WBC
# RBC
284
248
# Neuts
# Lymphs
# Monos
# PMN
# MN
Neut
Lymph
Eos
RBC
Manual
# WBC
124
135
# RBC
# Neuts
31
29
# Lymphs
38
45
# Monos
47
52
# Eos
# PMN
32
38
# MN
85
97
Neut
Lymph
RBC
Eos
Manual
# WBC
94
95
# RBC
298
325
% Neuts
47
52
%Lymphs
34
44
%Monos
20
%PMN
47
48
% MN
53
52
Results
WBC Linearity
Range
0-50 / L
50 - 5,000 / L
Max. Deviation
5 cells
10%
RBC Linearity
Range
0-50 / L
50 - 1,500 / L
Max. Deviation
5 cells
10%
Within Run Precision and Accuracy (Nominal 100 cells / L; 150 samples,
at least 50% abnormal)
Parameter
Stan. Dev. / Bias
%CV / %Bias
WBC
15
15%
RBC
15
15%
# PMN
20
20%
#MN
20
20%
Summary of features
Reduces:
Summary of Features
Reduces:
Labor intensive manual testing
Turn around time
Standardizes CSF analysis
Provides Quality Control for method previously
uncontrolled
No specialist needed to perform the test
Provides a platform for future developments
Investigating feasibility of other fluid assays
Synovial
Pleural
Amniotic
Performance Characteristics
WBC Linearity
Range
0 - 50 / L
50 - 5,000 / L
RBC Linearity
Range
0 - 50 / L
50 - 1,500 / L
Max. Deviation
5 cells
10%
Max. Deviation
5 cells
10%
Within Run Precision and Accuracy (Nominal 100 cells / L; 150 samples,
at least 50% abnormal)
Parameter
WBC
RBC
# PMN
#MN
%CV / %Bias
15%
15%
20%
20%
2500
2000
1500
1000
500
0
0
500
1000
1500
Manual RBC
2000
2500
3000
2500
2000
1500
1000
500
0
0
500
1000
1500
Manual WBC
2000
2500
3000
500
800
r = 0.953
y = 1.02x + 3
Syx = 16
Manual Mean = 18
ADVIA 120 Mean = 21
Bias = 3
ADVIA 120 # MN
400
350
300
r = 0.981
y = 0.81x + 2
Syx = 14
Manual Mean = 18
ADVIA 120 Mean = 17
Bias = -1
700
600
ADVIA 120 # PMN
450
250
200
150
500
400
300
200
100
100
50
0
0
100
200
300
Manual # MN
400
500
200
400
600
Manual # PMN
Comparison of manual mononucelar (MN) and polymorphonuclear (PMN) cell counts to ADVIA 120
800
200
350
300
ADVIA 120 # Lymph
250
200
r = 0.964
y = 0.86x + 1
Syx = 9
Manual Mean = 10
ADVIA 120 Mean = 10
Bias = 0
150
100
250
180
r = 0.928
y = 1.24x + 0
Syx = 8
Manual Mean = 4
ADVIA 120 Mean = 5
Bias = 1
160
140
ADVIA 120 # Mono
300
200
150
120
100
80
60
100
40
50
50
20
0
0
100
200
Manual # Neut
300
0
0
100
200
300
400
Manual # Lymph
50
100
Manual # Mono
150
200
6000
3000
5000
2500
4000
2000
Observed RBC
Observed WBC
3000
2000
1000
1500
1000
500
1000
2000
3000
Expected WBC
4000
5000
6000
500
1000
1500
Expected RBC
2000
2500
3000
RBC= 28 Cells/ L
RBC= 46 Cells/ L
WBC= 1 Cells/ L
WBC= 3 Cells/ L
Manual Result
Incorrect ADVIA 120 Result
WBC/L
25
1772
RBC/L
64300
38313
Undiluted Sample
4 minute incubation
incomplete sphering
10 minute incubation
sphering complete
WBC/L
RBC/L
%Lymphs
Manual Result
17
1060
25
61
650
86
WBC/L
RBC/L
Manual Result
75
1807
81
1277
WBC/L
RBC/L
%Lymphs
Manual Result
16
100
40
38
93
Back up slides
Multiple Sclerosis
100 % mononuclear
Lymphs/Monos/PMNs
CSF Cytograms
Cell Analysis Regions
Monos
Neuts
Lymphs
RBC
Noise
Eos
Research Use Only
Noise