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

Identifieur interne : 000575 ( PubMed/Checkpoint ); précédent : 000574; suivant : 000576

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

Auteurs : Deborah A. Payne [États-Unis] ; Katarina Baluchova [Slovaquie] ; Katell H. Peoc'H [France] ; Ron H N. Van Schaik [Pays-Bas] ; K C Allen Chan [Hong Kong] ; Masato Maekawa [Japon] ; Cyril Mamotte [Australie] ; Graciela Russomando [Paraguay] ; François Rousseau [Canada] ; Parviz Ahmad-Nejad [Allemagne]

Source :

RBID : pubmed:27321365

Abstract

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.

DOI: 10.1016/j.cca.2016.06.018
PubMed: 27321365


Affiliations:


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pubmed:27321365

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<name sortKey="Ahmad Nejad, Parviz" sort="Ahmad Nejad, Parviz" uniqKey="Ahmad Nejad P" first="Parviz" last="Ahmad-Nejad">Parviz Ahmad-Nejad</name>
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<div type="abstract" xml:lang="en">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.</div>
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<DateCreated>
<Year>2016</Year>
<Month>07</Month>
<Day>18</Day>
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<Year>2017</Year>
<Month>05</Month>
<Day>08</Day>
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<Year>2017</Year>
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<Title>Clinica chimica acta; international journal of clinical chemistry</Title>
<ISOAbbreviation>Clin. Chim. Acta</ISOAbbreviation>
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<ArticleTitle>Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach.</ArticleTitle>
<Pagination>
<MedlinePgn>59-69</MedlinePgn>
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<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="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.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="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.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="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.</AbstractText>
<CopyrightInformation>Copyright © 2016 Elsevier B.V. All rights reserved.</CopyrightInformation>
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<LastName>Payne</LastName>
<ForeName>Deborah A</ForeName>
<Initials>DA</Initials>
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<LastName>Baluchova</LastName>
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<Affiliation>Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin, Biomedical Center Martin, Division of Oncology, Mala Hora 4C, 036 01 Martin, Slovakia; Comenius University in Bratislava, Jessenius Faculty of Medicine in Martin, Department of Molecular Biology, Mala Hora 4C, 036 01 Martin, Slovakia.</Affiliation>
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<Affiliation>AP-HP Hôpital Beaujon, Service de Biochimie clinique, Clichy F-92118, France; Université Paris Diderot, UFR de Médecine site Bichat, INSERM UMRs-1149, Paris, France.</Affiliation>
</AffiliationInfo>
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<Affiliation>Department Clinical Chemistry, Erasmus University Medical Center, Rotterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
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<LastName>Chan</LastName>
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<Affiliation>Department of Chemical Pathology, Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong.</Affiliation>
</AffiliationInfo>
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<Affiliation>Department of Laboratory Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.</Affiliation>
</AffiliationInfo>
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<ForeName>Cyril</ForeName>
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<Affiliation>School of Biomedical Sciences and CHIRI Biosciences, Curtin University, Perth, Australia.</Affiliation>
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<Affiliation>Molecular Biology and Biotechnology Department, Instituto de Investigaciones en Ciencias de la Salud, Universidad Nacional de Asunción, Paraguay.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Rousseau</LastName>
<ForeName>François</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Biology, Direction médicale des services hospitaliers, CHU de Québec - Université Laval, Québec City, Canada; Department of Molecular Biology, Medical Biochemistry and Pathology, Faculty of Medicine, Université Laval, Québec City, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ahmad-Nejad</LastName>
<ForeName>Parviz</ForeName>
<Initials>P</Initials>
<AffiliationInfo>
<Affiliation>Institute for Medical Laboratory Diagnostics, Centre for Clinical and Translational Research (CCTR), HELIOS Hospital, Heusnerstraße 40, 42283 Wuppertal, Witten/Herdecke University, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<CollectiveName>IFCC Committee for Molecular Diagnostics (C-MD)</CollectiveName>
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<Language>eng</Language>
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<PublicationType UI="D016428">Journal Article</PublicationType>
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<ArticleDate DateType="Electronic">
<Year>2016</Year>
<Month>06</Month>
<Day>16</Day>
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<Country>Netherlands</Country>
<MedlineTA>Clin Chim Acta</MedlineTA>
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<ISSNLinking>0009-8981</ISSNLinking>
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<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">Good laboratory practice</Keyword>
<Keyword MajorTopicYN="N">ISO 15189</Keyword>
<Keyword MajorTopicYN="N">Infectious diseases</Keyword>
<Keyword MajorTopicYN="N">Informed consent</Keyword>
<Keyword MajorTopicYN="N">Inherited diseases</Keyword>
<Keyword MajorTopicYN="N">Molecular diagnostics</Keyword>
<Keyword MajorTopicYN="N">Molecular pathology</Keyword>
<Keyword MajorTopicYN="N">Molecular requisition</Keyword>
<Keyword MajorTopicYN="N">Oncology</Keyword>
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