Analytical quality goals—a review

Abstract

Analytical quality goals indicate how laboratory tests must perform to be clinically useful for their intended purpose. These goals have historically focused on analytical error assessment for quantitative methods and vary with measurand concentration or activity, and species. Although formalized quality goal models have been developed in human medicine, quality goals in veterinary medicine, to date, have not been formalized; use of human regulatory-based goals, consensus-based goals, or biologic variation-based goals have been reported most often. This review provides an overview of how quality goals are derived, how these may be used, and highlights challenges. Pending formal recommendations, individual veterinary laboratories should select quality goals that make the most sense clinically, logistically, and financially based on their individual needs and the needs of the clients that they serve.

Biological variation of routine haematology and biochemistry measurands in the horse

“…This standard of CV A < 0.5 CV I was achieved for most measurands studied, although there were some exceptions for both haematology (MCV, MCH, MCHC, RDW and platelets) and biochemistry measurands (chloride, sodium and urea). These performance standards applied to biological variation data are not only used in studies of biological variation, but also to assess performance of laboratory analysers . As such, the exceptions observed in the current study likely reflect the state of the art with regard to assay performance and improvement of assay performance should be prioritised by instrument manufacturers.…”

“…To determine adequate precision, the number of results with CV A < 0.5 CV I was assessed, representing the quality goal for desirable imprecision [2,10,14].…”

“…Studies on biological variation have been reported in a number of domestic animals, including haematology and biochemistry in dogs and cats [3][4][5][6][7]. From a laboratory perspective, such information assists in determining quality goals such as precision, accuracy and total error [8][9][10].…”

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

“…53 In addition to AAVLD, ISO 17025, and OIE, 2 other organizations produce standards or guidelines that potentially impact assay validation within a veterinary laboratory. These include guidelines from the American Society for Veterinary Clinical Pathology (ASVCP) 16,17,43 and the FDA branch that governs U.S. food safety and oversees the actions of the U.S. Food Emergency Response Network (FERN) and the Veterinary Laboratory Investigation and Response Network (Vet-LIRN). 46 However, there exists a need for more specific guidance covering assay development, modification, and validation of rtPCR test methods.…”

“…Available guidelines are often considered too expensive to follow, 8,11,13 not sufficiently specific (OIE), [53][54][55][56][57] or are not relevant for most of the molecular work performed in AAVLD-accredited VDLs. 16,17,43,46 The AAVLD Laboratory Technology Committee (LTC) was convened to generate a set of suggested guidelines intended to consolidate the guidance from OIE and to facilitate alignment with the AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory (https://www.aavld.org/ accreditation-requirements-page). To this end, the LTC recommendations are described and compared to OIE guidance and the AAVLD accreditation requirements.…”