Evaluating an external quality assurance program for semen analysis in China during 2009-2020

Area of Science:

• Reproductive Medicine
• Andrology
• Laboratory Science

Background:

• Semen analysis (SA) is vital for diagnosing male infertility and reproductive diseases.
• Standardization challenges, subjective assessments, and automated procedure issues hinder accurate SA.
• Quality assurance (QA) and training are essential for consistent laboratory results.

Purpose of the Study:

• To assess the effectiveness of external quality assurance (EQA) schemes in improving semen analysis consistency in China.
• To identify areas of significant interlaboratory variability in SA parameters.
• To emphasize the need for standardized training and adherence to WHO guidelines.

Main Methods:

• An EQA scheme involving 124 Chinese laboratories from 2009-2020.
• Annual distribution of semen aliquots for concentration, video recordings for motility, and smears for morphology.
• Samples sourced from healthy donors and patients.

Main Results:

• Median coefficient of variation (CV) for sperm concentration was 26.6%, reduced to 13.6% with a 100 µm counting chamber.
• CV for progressive motility (13.2%) and total motility (11.8%) were acceptable, but nonprogressive motility was high (50.8%).
• Sperm morphology assessment showed high variability (44.4%) regardless of criteria.

Conclusions:

• Significant interlaboratory variability persists in SA, particularly for sperm concentration and morphology.
• Increased participation in EQA schemes and standardized training centers are critical.
• Adoption of WHO-recommended procedures adapted to Chinese standards is necessary to improve SA accuracy.