Regulatory Significance 5/10

Global EQA for Semen Analysis: 34 Years of Inconsistency and High Inter-Laboratory Variability

This systematic review of 29 studies spanning 34 years reveals that external quality assessment programs for semen analysis vary widely across countries, with no global consensus on participation mandates, assigned-value calculations, or acceptance limits. Coefficients of variation for sperm concentration, motility, and morphology ranged from 12.7% to 375%, highlighting substantial inter-laboratory disagreement that demands coordinated international standardisation efforts.

The original study

How has the external quality assessment/proficiency testing of semen analysis been developed in the past 34 years: a review.

Authors
Zheng Y, Wu Y, Yu L, Jia Y, Yang T, Cheng Q, et al.
Journal
Clinical chemistry and laboratory medicine
Type
Journal Article, Review
PMID
39508807
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Original abstract

Male infertility has become an important issue of global concern. Semen analysis is the cornerstone of male fertility assessment. External quality assessment (EQA) of sperm concentration, motility, and morphology is widely recognized in the world. However, over the past 34 years, the implementation of EQA for semen analysis has varied across different countries, and there is no global consensus. The goal of this paper is to first explore the overall development of EQA during this period. Secondly, it aims to discuss the extent of difference of participating laboratories in different countries. Finally, the paper examines the differences in EQA programs developed by various EQA providers in order to seek a global standard. In total, 29 papers met the inclusion criteria and were included in this review. There is inconsistent in the implementation of EQA across different countries, and there is no global consensus. Policies for EQA of semen analysis vary from country to country. Some countries mandate laboratory participation, while others permit voluntary involvement. Different EQA organizers choose different ways to calculate assigned value and acceptance limits. The coefficient of variation (CV) for each EQA item was large. The CVs of concentration, motility, morphology, and viability were 12.7-138.0 %, 17.0-127.0 %, 7-375 %, and 6-41.1 %, respectively. The results of the semen analysis varied considerably among the participating laboratories. The collaborative efforts of national policymakers, EQA organizers, and all participating laboratories are essential to improving the current situation.