Suggested guidelines for validation of real-time PCR assays in veterinary diagnostic laboratories

Kathy Toohey-Kurth, Monica M. Reising, Rebecca L. Tallmadge, Laura B. Goodman, Jianfa Bai, Steven R. Bolin, Janice C. Pedersen, Mangkey A. Bounpheng, Roman M. Pogranichniy, Jane Christopher-Hennings, Mary Lea Killian, Donna M. Mulrooney, Roger Maes, Shri Singh, Beate M. Crossley

Research output: Contribution to journalArticlepeer-review

8 Scopus citations


This consensus document presents the suggested guidelines developed by the Laboratory Technology Committee (LTC) of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) for development, validation, and modification (methods comparability) of real-time PCR (rtPCR) assays. These suggested guidelines are presented with reference to the World Organisation for Animal Health (OIE) guidelines for validation of nucleic acid detection assays used in veterinary diagnostic laboratories. Additionally, our proposed practices are compared to the guidelines from the Foods Program Regulatory Subdivision of the U.S. Food and Drug Administration (FDA) and from the American Society for Veterinary Clinical Pathology (ASVCP). The LTC suggestions are closely aligned with those from the OIE and comply with version 2021-01 of the AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory, although some LTC recommendations are more stringent and extend beyond the AAVLD requirements. LTC suggested guidelines are substantially different than the guidelines recently published by the U.S. FDA for validation and modification of regulated tests used for detection of pathogens in pet food and animal-derived products, such as dairy. Veterinary diagnostic laboratories that perform assays from the FDA Bacteriological Analytical Method (BAM) manual must be aware of the different standard.

Original languageEnglish (US)
Pages (from-to)802-814
Number of pages13
JournalJournal of Veterinary Diagnostic Investigation
Issue number6
StatePublished - Nov 1 2020
Externally publishedYes


  • accreditation
  • methods comparability
  • real-time PCR
  • validation
  • verification

ASJC Scopus subject areas

  • veterinary(all)


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