External quality control in the andrology laboratory: an experimental multicenter trial

Area of Science:

• Andrology
• Reproductive Medicine
• Clinical Laboratory Science

Background:

• Semen analysis is crucial for male fertility assessment.
• External quality control (EQC) programs are essential for standardizing laboratory performance.
• Inter-laboratory variability in semen analysis can impact diagnostic accuracy.

Purpose of the Study:

• To assess the performance of 10 andrology laboratories in an external quality control study for semen analysis.
• To evaluate the variability in sperm concentration, morphology, and motility measurements.
• To compare EQC results with internal quality control (IQC) data.

Main Methods:

• Distribution of standardized semen samples (eight for concentration, three for morphology slides, five cryopreserved for motility) to 10 participating laboratories.
• Calculation of coefficients of variation (CVs) for sperm concentration, morphology, and motility.
• Comparison of EQC CVs with reported mean CVs from IQC.

Main Results:

• EQC CVs for sperm concentration ranged from 23% to 73%, with higher variability at lower concentrations.
• EQC CVs for sperm morphology varied from 25% (normal heads) to 87% (abnormal midpieces).
• EQC CV for sperm motility was 21%, compared to IQC CVs of 10% for concentration, 8% for morphology, and 8% for motility.

Conclusions:

• Significant inter-laboratory variability exists in semen analysis parameters, particularly for sperm concentration and morphology.
• Current EQC performance highlights a need for improved standardization and training in andrology laboratories.
• EQC results indicate a substantial difference compared to IQC, emphasizing the importance of robust external assessment programs.