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- Title
Suggested guidelines for validation of real-time PCR assays in veterinary diagnostic laboratories.
- Authors
Toohey-Kurth, Kathy; Reising, Monica M.; Tallmadge, Rebecca L.; Goodman, Laura B.; Bai, Jianfa; Bolin, Steven R.; Pedersen, Janice C.; Bounpheng, Mangkey A.; Pogranichniy, Roman M.; Christopher-Hennings, Jane; Killian, Mary Lea; Mulrooney, Donna M.; Maes, Roger; Singh, Shri; Crossley, Beate M.
- Abstract
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.
- Subjects
WORLD Organization for Animal Health; VETERINARY clinical pathology; GUIDELINES; MEDICAL laboratories; ANIMAL health; NUCLEIC acids
- Publication
Journal of Veterinary Diagnostic Investigation, 2020, Vol 32, Issue 6, p802
- ISSN
1040-6387
- Publication type
Article
- DOI
10.1177/1040638720960829