MES SQA-V Gold User Manual page 51

User Guide Version 2.60 I-button WHO 5th
Precision and accuracy established in clinical trials
using human semen samples
Clinical claims:
Specificity
Concentration: 85%
Motility: 80%
Morph. Norm Forms (WHO 3
Morph. Norm Forms (WHO 4
Morph. Norm Forms (WHO 5
Postvasectomy: 90% of motile cells detected
Sensitivity
Concentration: 90%
Motility: 85%
Morph. Norm Forms (WHO 3
Morph. Norm Forms (WHO 4
Correlation to Manual Method
Concentration: 0.9
Motility: 0.85
Morph. Norm Forms (WHO 3
Morph. Norm Forms (WHO 4
Morph. Norm Forms (WHO 5
Linearity
Linear Sperm Concentration throughout the SQA-V dynamic
range of 2M/ml to 400M/ml
 Squared regression coefficient of Dilution Curve R ≥0.9.
 Averaged coefficient of variation CV of measured vs. expected
sperm concentration ≤ 20%.
Note: Claims are less than actual correlations noted (see tables 1
and 2).
Background: The SQA-V concentration, motility and morphology
readings were compared to standard microscopic results based
rd th th
on WHO 3 , 4 and 5 standards and MES protocols. Four
independent clinical trials were conducted at MES lab, Tel
Hashomer andrology dept and Ramat Marpe lab (Israel) and ART
laboratory, University Hospital of Nantes (France). A total of
>750 human semen samples were analyzed as described below
with approximately 350 samples of low quality and tested in the
Postvasectomy mode. Among them, 246 semen samples were
tested at University Hospital of Nantes.
#Samples Fresh Washed
>750 >300
Analytical Specificity:
To achieve analytical specificity a specific wave length of light
which is maximally absorbed by sperm cells and minimally
absorbed by other cells and seminal plasma is used.
Low noise and high electronic resolution hardware
components and compensation circuits ensure that analytical
specificity is optimized.
Limitations of clinical specificity:
 Highly viscous samples can only be read accurately with
liquefaction (QwikCheck™ Liquefaction Kit used).
Sample size must be >0.7ml for fully automated tests.
% Normal Morphology is a parameter derived from the
electronic signals of the system by a proprietary algorithm.
This is not a direct assessment of the stained smears.
Results obtained from the use of the SQA-V visualization
system may be affected by the subjectivity of the operator.
Dynamic range limitation as stated above.
Revision 21_Sep_2015
rd
): 65%
th
): 60%
th
): 90%
rd
): 85%
th
): 65%
rd
): 0.65
th
): 0.45
th
): 0.45
2
High
Frozen
Sensitivity
42 30 >350

Table 1: Sensitivity/Specificity
SQA-V vs. Microscope
Trial #1:
Concentration
Motility
rd
Morph Norm Forms (WHO 3
Trial #2:
Concentration
Motility
th
Morph Norm Forms (WHO 4
Trial #3: High Sensitivity (Postvasectomy - see table #5)
Motile Sperm Cells
Immotile Sperm Cells
Trial #4 (ART laboratory, University Hospital
of Nantes, France):
SQA-V vs. Microscope
th
Morph Norm Forms (WHO 5
Table #2: Correlation to Manual Method
Parameters
Sperm Concentration
Motility
Morphology WHO 3 rd
th th
Morphology WHO 4 / 5
MSC
* Correlation is low due to narrow dynamic range of this
parameter per strict criteria and manual analysis subjectivity.
51
Sensitivity Specificity
100% 95%
97% 85%
) 94% 75%
94% 90%
87% 90%
) 69% 70%
95% 95%
99% 100%
Negative
Predictive Specificity
Value
) 92.5 97.9
Correlation Coefficients
Trial #1 Trial #2
0.93 0.94
0.86 0.87
0.66 -
- 0.49*
- 0.79