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Public health implementation of pathogen genomics: the role for accreditation and application of ISO standards

Susan A Ballard1, Norelle L Sherry1,2,3, Benjamin P Howden1,2,3,4

  • 1Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth St Melbourne, 3000, Australia.

Microbial Genomics
|August 17, 2023
PubMed

Insights

Pathogen genomics is now a vital public health tool for disease surveillance and outbreak investigations. Ensuring accuracy through test validation and quality systems is crucial for reliable results and international accreditation.

Area of Science:

  • Microbiology
  • Genomics
  • Public Health

Background:

  • Pathogen genomics has evolved from a research tool to a routine public health application.
  • Its use in surveillance, outbreak investigations, and disease control has significant implications.

Purpose of the Study:

  • To outline key international standards and processes for laboratory accreditation in pathogen genomics.
  • To emphasize the importance of quality systems and test validation for public health microbiology.

Main Methods:

  • Review of international standards and regulatory frameworks relevant to diagnostic testing.
  • Discussion of quality system implementation and test validation processes.

Main Results:

  • Identification of critical international standards for pathogen genomics accreditation.
  • Highlighting the necessity of robust quality management systems.

Conclusions:

  • Accreditation for pathogen genomics requires adherence to international quality and validation standards.
  • Implementing these standards ensures the accuracy and reliability of public health microbiology data.
Keywords:
international standardslaboratory accreditationwhole-genome sequencing

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