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Related Experiment Videos

A quality control system for the optimized sperm penetration assay

A Johnson1, B Bassham, L I Lipshultz

  • 1Baylor College of Medicine, Houston, Texas 77030, USA.

Fertility and Sterility
|October 1, 1995
PubMed
Summary

Developing a robust quality control system for the sperm penetration assay (SPA) is crucial. Using frozen semen controls significantly enhances the assay

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Area of Science:

  • Reproductive biology and andrology.
  • Clinical laboratory science.

Background:

  • The sperm penetration assay (SPA) is a valuable tool for assessing male fertility.
  • Optimizing the SPA requires a reliable quality control system to ensure accurate and reproducible results.
  • Interassay variability and assay stability are critical factors for clinical laboratory certification.

Purpose of the Study:

  • To establish a quality control system for the optimized sperm penetration assay (SPA).
  • To evaluate interassay variability and long-term stability of the SPA using this control system.

Main Methods:

  • Consecutive weekly testing of semen donors (7-139 weeks) to assess natural biologic variation.
  • Intra-assay variability determined by testing aliquoted semen samples.
  • Frozen semen aliquots from multiple individuals used as controls, tested across different assay days and re-tested after 5 years.

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Main Results:

  • Donor semen analyses and SPAs showed high coefficients of variation (20% to >40%), exceeding intra-assay variability.
  • Frozen semen controls exhibited low coefficients of variation.
  • No significant differences in SPA values were observed when frozen samples were re-tested after 5 years, demonstrating assay stability.
  • The normal fertile range lower limit remained stable over 2 years.

Conclusions:

  • Fresh semen samples are inadequate as positive controls for the SPA.
  • Frozen semen controls provide a stable and reproducible method for quality assurance in the SPA.
  • The optimized SPA, with frozen semen controls, is a highly reproducible assay meeting clinical laboratory certification standards.