Background: Organizations providing semen analysis proficiency testing/QC programs (CAP, NEQAS) require laboratories to show
proficiency and quality control across three main semen analysis parameters: Sperm concentration, motility and morphology. To
date, the QC/proficiency testing samples provided by these organizations are for testing only sperm concentration. Motility and
morphology challenges currently require a live semen sample which is too complex to deliver and the target values are not
standardized between labs (Exception: IVF Australia Proficiency challenge).
Response: In order to ensure that the automated sperm analyzer is providing high quality and consistent test results and that the
laboratory is maintaining appropriate proficiency, MES has established four independent concentration/motility/morphology
quality control systems:
1. Autocalibration and Self-Test
2. QwikCheck Quality Control Material (including zero level lower limit motility detection)
3. Calibration Parameter Confirmation
4. Routine Concentration, Motility and Morphology analyzer validation
AUTOCALIBRATION AND SELF-TEST: An electronic testing process that is initiated each time the analyzer is activated.
• Modulated analog signals are generated by the system. These signals are similar to signals detected during actual semen
testing (when spermatozoa cross the instrument light beam in the thin section of the SQA testing capillary).
• The same motility and morphology algorithm used for converting electronic signals into clinical test results is used in this
electronic simulation of motility and morphology.
• If the Self-Test simulation reports a reading that exceeds the allowable range, the system will report FAILED SELF-TEST
and will not allow a test to be run. Corrective action instructions are displayed on the screen.
• When the SQA passes Auto-Calibration and Self-Test, a “Service Parameters” report can be printed and kept on file to
prove system preparedness and compliance.
EXTERNAL QUALITY CONTROL
QwikCheck™ Beads are an assayed external quality control for testing Concentration and zero level Motility (manufactured by
Medical Electronic Systems – www.mes-global.com):
• Three concentration levels are provided in a kit.
• The Negative Control level of the QwikCheck™ Beads kit verifies that the SQA is not reporting false positive readings for
both concentration and motility (MSC) at level = 0.
• A printed report of the control results will demonstrate the accuracy of the system and the operator’s proficiency
CALIBRATION PARAMETER CONFIRMATION
Once or twice per year, the Self-Test data of the SQA can be sent to MES for calibration verification. Based on a comparison of the
initial analyzer calibration data maintained by the manufacturer (MES) and the current self-test data, the status of the SQA
calibration can be evaluated.
CONCENTRATION, MOTILITY AND MORPHOLOGY VALIDATION ON THE SQA ANALYZER
Based on CLIA regulations and MES recommendation, it is advisable to run the QwikCheck Beads Validation and Training kit that
verifies:
• Linearity and Reportable Range
• Precision – Replication & Detection Limit
• Accuracy
MES also recommends that the SQA is validated semi-annually using the QwikCheck Beads Precision and Linearity kit to verify:
• Linearity and Reportable Range
• Precision and Lower Limit Detection
• Concentration Accuracy
In addition and in coordination with the QwikCheck Beads kit testing, MES recommends assessing fresh semen concentration,
motility and morphology to confirm the SQA accuracy and user proficiency. The following is a protocol for running the automated
analyzer and comparing the results to manual analysis (back-up method):
• Run, in duplicate, 10 fresh semen samples on the SQA; 5 should be low motility (<40%) and 5 normal motility (>=40%)
range.
• In parallel assess, in duplicate, the concentration, motility and morphology of the same samples under the microscope
per WHO 5th edition manual guidelines.
• Run samples at room temperature within a 2 minute timeframe between the two methods (manual morphology can be
assessed > 2 minutes following the laboratory protocol for manual morphology assessment).
• Compare the automated and manual results (Can be sent to MES for statistical evaluation).
In conjunction with the Auto-Calibration, Self-Test, External Daily QC, Calibration Parameter Confirmation and running Validation
kits, this routine mini-validation proves system function, accuracy and user proficiency for Concentration, Motility and
Morphology.
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