Research Information System
Turk Hijyen ve Deneysel Biyoloji Dergisi, vol.74, no.4, pp.333-340, 2017 (Scopus)
Objective: Assessment of the validity of a method including TS EN ISO 17025 and TS EN ISO 15189, is a formal requirement of accreditation standards. Before routine testing, validity of every test should be assessed in accordance with internationally accepted criteria. Validation / verification requirements varies according to the criteria that a test is CE/FDA approved or is an in-house test, or gives qualitative or quantitative results. While verification is adequate for CE approved tests, validation is necessary for inhouse tests. Methods: In this study, it was evaluated the validity of commercial CE approved tests, such as anti-nuclear antibody IgG IFAT, anti-endomysium IgA IFAT anti-gliadin IgA IFAT. Accuracy and reproductibility of the tests (intraassay, inter-assay) are performed for the verification of the tests and samples from an accredited laboratory are used. Results: CE approved commercial anti-nuclear antibody IgG IFAT, anti-endomysium IgA IFAT, anti-gliadin IgA IFAT with 100% accuracy and precision are considered as valid in our laboratory conditions. Conclusion: As a result the method used in our study for the validity of the qualitative serological tests is found to be applicable and use of a test sample from an accredited institution as a control material were considered to be practical in cases where it is difficult to obtain certified material.