MES SQA-V Gold User Manual page 52

User Guide Version 2.60 I-button WHO 5th
Method comparison:
SQA-V was compared to the microscope based on WHO 3
(Trial #1), 4 th (Trial #2) and WHO 5
Sensitivity and Specificity were calculated using ROC
curves with the cutoffs based on the reference values of WHO
rd th th
3 , 4 and 5 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
Entire Range
5-40
Sperm
41-80
Concentration
>80
Entire Range
10-50
Motility
51-55
>55
Table #4: Mean Values and Precision: Trial #4 (n=246)
Mean
Semen
Parameter
Op1 Op2
Sperm
41.0 40.2
Concentration
Total Motility 54.7 56.9
PR Motility 37.9 39.0
NP Motility 16.8 17.9
Morphology 7.6
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
Revision 21_Sep_2015
th (Trial #4) guidelines.
Method
SQA-V Microscope
CV% CV%
3.1 6.1
5.2 5.9
2.1 5.5
2.5 3.2
5.1 7.2
7.6 10.3
1.5 3.4
6.0 4.1
CV, %
SQA-V Manual SQA-V
41.4 11.5
54.9 10.7
36.6 13.3
18.4 27.3
7.6 11.5 27.4
# Samples % Samples
Motile Sperm Motile Sperm
Detected Detected
rd
3.4
5.0
Limitations of method:
7.5
Samples were assessed by different operators using a microscope
and the SQA-V. Inter-operator subjectivity may have affected the
6.8
results of the study.
6.5
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