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    Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach

    Access Status
    Fulltext not available
    Authors
    Payne, D.
    Baluchova, K.
    Peoc'h, K.
    van Schaik, R.
    Chan, K.
    Maekawa, M.
    Mamotte, Cyril
    Russomando, G.
    Rousseau, F.
    Ahmad-Nejad, P.
    Date
    2015
    Type
    Journal Article
    
    Metadata
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    Citation
    Payne, D. and Baluchova, K. and Peoc'h, K. and van Schaik, R. and Chan, K. and Maekawa, M. and Mamotte, C. et al. 2015. Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach. Clinica Chimica Acta.
    Source Title
    Clinica Chimica Acta
    DOI
    10.1016/j.cca.2016.06.018
    ISSN
    0009-8981
    School
    School of Biomedical Sciences
    URI
    http://hdl.handle.net/20.500.11937/3222
    Collection
    • Curtin Research Publications
    Abstract

    © 2016.Background: Multiple organizations produce guidance documents that provide opportunities to harmonize quality practices for diagnostic testing. The International Organization for Standardization ISO 15189 standard addresses requirements for quality in management and technical aspects of the clinical laboratory. One technical aspect addresses the complexities of the pre-examination phase prior to diagnostic testing. Methods: The Committee for Molecular Diagnostics of the International Federation for Clinical Chemistry and Laboratory Medicine (also known as, IFCC C-MD) conducted a survey of international molecular laboratories and determined ISO 15189 to be the most referenced guidance document. In this review, the IFCC C-MD provides case-based examples illustrating the value of select pre-examination processes as these processes relate to molecular diagnostic testing. Case-based examples in infectious disease, oncology, inherited disease and pharmacogenomics address the utility of: 1) providing information to patients and users, 2) designing requisition forms, 3) obtaining informed consent and 4) maintaining sample integrity prior to testing. Conclusions: The pre-examination phase requires extensive and consistent communication between the laboratory, the healthcare provider and the end user. The clinical vignettes presented in this paper illustrate the value of applying select ISO 15189 recommendations for general laboratory to the more specialized area of Molecular Diagnostics.

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