External quality assessment scheme for sperm DNA fragmentation: A pilot study in China

Abstract

Abstract Background: The aim of this article is to establish an external quality assessment(EQA) scheme for sperm DNA fragmentation(SDF) detection, and to assess the feasibility of the scheme. Material and Methods: In 2021 and 2022, 10 and 28 laboratories in China volunteered to participate in the EQA program. The ejaculates that remained after semen analysis were mixed to provide two lots (one high and one low ), the pooled semen samples were evenly distributed into cryotubes with the volume of 500μl, which were then directly immersed in liquid nitrogen for preservation. Samples were transported to each laboratory in dry ice. Participants were asked to test EQA samples according to the laboratory’s routine procedure. Results: A large spread of results was obtained for the four samples, and the highest values were 13.7, 4.2, 8.0 and 4.0 times the lowest, respectively. The Coefficient of variations (CVs) were very high for samples with 46.6%, 30.1%, 26.7% and 30.3%, respectively. The CVs of the samples with high SDF values were lower than those of the samples with low SDF values. There was no significant difference between the results of sperm chromatin structure assay(SCSA) and sperm chromatin dispersion(SCD). In 2021, the CVs of low value sample and high value sample of 10 participants were 46.6% and 30.1%, and the CVs decreased to 32.5% and 22.7% in 2022. Conclusion: This is the first study to evaluate the EQA program on SDF, which involved a number of laboratories, and demonstrated to be feasible. It is recommended that all laboratories are expected to participate in the EQA of SDF to ensure the accuracy of the results.