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Methylated DNA Immunoprecipitation
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Establishing a stable, repeatable platform for measuring changes in sperm DNA methylation.

Mohammad Abbasi1, Andrew D Smith2, Harish Swaminathan1

  • 1Episona, 69 N. Catalina Ave., Pasadena, USA.

Clinical Epigenetics
|September 20, 2018
PubMed
Summary
This summary is machine-generated.

Interpreting Clinical Laboratory Improvement Amendments (CLIA) guidelines for epigenetic assays is crucial for clinical applications. This study validates the Illumina Infinium platform for profiling DNA methylation in male infertility diagnostics.

Keywords:
CLIAClinical Laboratory Improvement AmendmentsDNA methylationEpigeneticsLDTLaboratory-developed testMale infertility

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Area of Science:

  • Epigenetics
  • Molecular Biology
  • Reproductive Medicine

Background:

  • Sperm DNA methylation alterations correlate with male infertility and poor embryo development.
  • Clinical translation of these findings requires robust, stable platforms resistant to batch effects.
  • Existing regulatory standards like Clinical Laboratory Improvement Amendments (CLIA) require interpretation for modern epigenetic assays.

Purpose of the Study:

  • To interpret CLIA technical validation requirements for DNA methylation profiling.
  • To validate the Illumina Infinium platform for clinical use in male infertility diagnostics.
  • To establish operating parameters ensuring accuracy and repeatability.

Main Methods:

  • Experimental design to meet CLIA technical validation requirements.
  • Application of Illumina Infinium platform (450HM, MethylationEPIC) for DNA methylation profiling.
  • Determination of operating parameters and performance characteristics.

Main Results:

  • Demonstrated a viable interpretation of CLIA guidelines for epigenetic assays.
  • Provided an experimental design and results meeting CLIA validation standards.
  • Established operating parameters for the Illumina Infinium platform.

Conclusions:

  • CLIA guidelines can be adapted for high-throughput epigenetic assays.
  • The Illumina Infinium platform is suitable for clinical diagnostic applications.
  • This work facilitates the clinical use of DNA methylation profiling for male infertility.