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