MES SQA-V Gold User Manual page 53

User Guide Version 2.60 I-button WHO 5th
SQA-V Automated
System and Visualization
System
Visualization System only
Microscope only
SQA-V Linearity
Clinical claims:
 Linear Sperm Concentration throughout the SQA-V dynamic
range of 2M/ml to 400M/ml:
Squared regression coefficient of Dilution Curve R

Averaged coefficient of variation CV of measured vs.

expected sperm concentration ≤ 20%.
Goal: To demonstrate the ability of the SQA-V to accurately
report sperm concentration along the dynamic range of the
system using sequentially diluted human semen samples.
Methodology: 4 fresh human semen samples were pooled,
divided into two aliquots and centrifuged at 600g for 15 minutes.
The seminal plasma was decanted and the pellets were re-
suspended in washing media: DPBS & HepesHTF. Sequential
dilutions were run in 4 SQA-V systems.
Limitations of method:
Dilution errors contribute to the accuracy of the linearity
test results.
Sample handling errors such as the introduction of bubbles
into the testing capillary can cause inaccurate readings.
Revision 21_Sep_2015
207 95%
193 89%
161 74%
2
≥0.9.

Results:
1. Squared regression coefficient R
was found to be 0.992 (note: graph displaying results of four
SQA-V's and DPBS and Hepes dilution media).
2. Averaged coefficient of variation CV of measured vs. expected
sperm concentration was 10%.
53
2
of Dilution Curve (trend line)