An internationally recognized quality assurance system for diagnostic parasitology in animal health and food safety, with example data on trichinellosis.

A quality assurance (QA) system was developed for diagnostic parasitology and implemented for several diagnostic assays including fecal flotation and sedimentation assays, trichomonad culture assay, and the testing of pork and horse meat for Trichinella to facilitate consistently reliable results. The system consisted of a validated test method, procedures to confirm laboratory capability, and protocols for documentation, reporting, and monitoring. Specific system components included a quality assurance manual, training program, proficiency panels, inter-laboratory check-sample exchange program, assay critical control points, controls, and audits. The quality assurance system of the diagnostic laboratory was audited according to ISO/IEC Standard 17025 by an international third party accrediting body and accredited as a testing laboratory for the specific parasitology tests. Test results generated from the laboratory were reliable and scientifically defensible according to the defined parameters of the tests and were therefore valid for a variety of purposes, including food safety, international trade, and declaration of disease status in an animal, herd, farm, or region. The system was applicable to various test methods for the detection of parasites in feces or other samples, and a digestion test system developed for Trichinella was used as an example. A modified tissue digestion assay was developed, validated, and implemented by the Canadian Food Inspection Agency's Centre for Animal Parasitology for efficiency and quality assurance. The details of the method were properly documented for routine testing and consisted of a homogenization process, an incubation at 45+/-2 degrees C, and two sequential sedimentations in separatory funnels to concentrate and clarify final aliquots for microscopic examination. To facilitate consistently reliable test results, 14 critical control points were identified and monitored, analysts were certified, and the test system verified through the use of validation data, proficiency samples, and training modules.