226 human semen samples were tested at Medical Electronic
Systems, LTD and Nantes University France to confirm the Accuracy and
Precision of the SQA-VISION
To test the new convenience features of the SQA-Vision vs.
the SQA-V and manual semen assessment: Swim-up, Density Gradient,
Longevity, Vitality, Morphology Counter, Scanning Debris/Round Cells,
SQA-Vision Visualization Validation. These parameters were always
available to the SQA-V customers, but were tracked or recorded manually
on separate pages or forms. The new SQA-Vision system is based on the
SQA-V platform (1), but streamlines the assessment and data collection
processes by allowing this information to be part of the standard
patient record. The objective of this trial is to determine that these
semen assessment features perform as designed, and provide the correct
results vs. reference method (SQA-V and manual semen assessment where
applicable) and vs. manufacturer claims. None of these convenience
features include new algorithms for reporting semen values.
Additionally, some of the features are not run automatically on the
SQA-Vision, but are run manually using the visualization system of the
SQA-Vision instead of the microscope. In these cases, the microscope
will be considered the GOLD STANDARD for comparison.
DOWNLOAD STUDY HERE: Medical Electronic Systems SQA-VISION Development Validation
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