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

Area of Science:

• Reproductive Medicine
• Andrology
• Laboratory Quality Management

Background:

• Sperm DNA fragmentation (SDF) is a critical indicator of male reproductive health.
• Standardized methods for SDF detection are essential for accurate clinical interpretation.
• External quality assessment (EQA) programs are vital for ensuring laboratory performance and result consistency.

Purpose of the Study:

• To establish and assess the feasibility of an external quality assessment (EQA) scheme for sperm DNA fragmentation (SDF) detection.
• To analyze abnormal SDF results and identify areas for laboratory improvement.
• To evaluate the impact of EQA participation on laboratory performance over time.

Main Methods:

• Implementation of an EQA program involving laboratories in China for SDF detection in 2021 and 2022.
• Distribution of multiple SDF samples for analysis using various detection methods.
• Statistical analysis of results, including coefficients of variation (CVs), to assess inter-laboratory variability.
• Comparison of results between sperm chromatin structure assay (SCSA) and sperm chromatin dispersion (SCD) methods.

Main Results:

• High inter-laboratory variability (CVs ranging from 26.7% to 46.6%) was observed across four EQA samples.
• Coefficients of variation (CVs) were lower for samples with high SDF values compared to low SDF values.
• Participating laboratories showed improved performance, with decreased CVs for both low and high SDF samples from 2021 to 2022.
• No significant difference was found between SCSA and SCD methods regarding SDF detection variability.

Conclusions:

• The developed EQA scheme for SDF detection is feasible and effective.
• The EQA program has demonstrated a positive impact on improving laboratory accuracy in SDF testing.
• It is recommended that all laboratories performing SDF analysis participate in EQA to ensure reliable and accurate results.