Revision 21_Sep_2015
52
User Guide Version 2.60 I-button WHO 5th
Method comparison:
SQA-V was compared to the microscope based on WHO 3
rd
(Trial #1), 4
th
(Trial #2) and WHO 5
th
(Trial #4) guidelines.
Sensitivity and Specificity
were calculated using ROC
curves with the cutoffs based on the reference values of WHO
3
rd
, 4
th
and 5
th
guidelines (see Table #1).
Correlation
coefficients of the SQA-V results to the manual
method are presented in the Table #2.
Precision
: Inter-device (Tables #3) and intra-device (Table
#4) variations were compared to inter- and intra-operator
variability using Coefficients of Variation (CV, %). Duplicate
samples were assessed by two methods. The CVs
characterizing precision were calculated for multiple semen
parameters.
The
POSTVASECTOMY
test (Trial #3) compared three
assessment methods:
o
Microscope (standard slide: X400; 10 fields of view)
o
SQA-V (SQA-V + SQA-V visualization)
o
SQA-V visualization system (see table #2).
Immotile cells were analyzed by use of the SQA-V
visualization system.
218 semen specimens contained motile cells and were used
as the basis for the Post Vas visualization method comparison
(Table #5).
Table #3: Precision: Trial #1 and #2 (n=154)
Parameter
Range
Method
SQA-V
CV%
Microscope
CV%
Sperm
Concentration
Entire Range
3.1 6.1
5-40
5.2 5.9
41-80
2.1 5.5
>80
2.5 3.2
Motility
Entire Range
5.1 7.2
10-50
7.6 10.3
51-55
1.5 3.4
>55
6.0 4.1
Table #4: Mean Values and Precision: Trial #4 (n=246)
Semen
Parameter
Mean CV,
%
Op1 Op2 SQA-V
Manual
SQA-V
Sperm
Concentration
41.0 40.2 41.4 11.5 3.4
Total Motility
54.7
56.9
54.9
10.7
5.0
PR Motility
37.9
39.0
36.6
13.3
7.5
NP Motility
16.8
17.9
18.4
27.3
6.8
Morphology 7.6
7.6
11.5
27.4 6.5
Note: Op1 - operator 1; Op2 - operator 2
Table #5: Percentage Motile Cells Detected: Trial #3
Postvasectomy mode
Method Comparison of
218 Samples with Motile
Cells
# Samples
Motile Sperm
Detected
% Samples
Motile Sperm
Detected
Limitations of method:
Samples were assessed by different operators using a microscope
and the SQA-V. Inter-operator subjectivity may have affected the
results of the study.
