title: Quality assurance for in vitro alternative test methods: quality control issues in test kit production.
abstract: In vitro toxicology methods are being adopted by regulatory agencies worldwide. Many of these methods have been validated by using proprietary materials, often in the form of test kits. Guidelines for the use of Good Laboratory Practice methods for in vitro methods have been proposed. However, users of the data from these methods also need to be reassured that the proprietary materials and the test kits will provide consistent, good quality data over time, not just during the validation process. This paper presents an overview of the methods currently used by representatives of kit manufacturers and contract testing laboratories to ensure that the results from methods that utilise test kits are reproducible over time and across different types of test materials. This information will be valuable as a basis for future discussion on the need for formalised oversight of the quality of these materials.
authors.affiliation: US Environmental Protection Agency, Office of Pesticide Programs (7506C), Washington, DC 20460-001, USA. amy.rispin@epa.gov
authors.forename: Amy
authors.initials: A
authors.lastname: Rispin
authors.forename: John W
authors.initials: JW
authors.lastname: Harbell
authors.forename: Mitchell
authors.initials: M
authors.lastname: Klausner
authors.forename: Foster T
authors.initials: FT
authors.lastname: Jordan
authors.forename: Sandra
authors.initials: S
authors.lastname: Coecke
authors.forename: Kailash
authors.initials: K
authors.lastname: Gupta
authors.forename: Katherine
authors.initials: K
authors.lastname: Stitzel
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D066298:In Vitro Techniques; D011786:Quality Control; D015203:Reproducibility of Results