Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach
© 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 c...
| Main Authors: | , , , , , , , , , |
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| Format: | Journal Article |
| Published: |
Elsevier BV
2015
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| Online Access: | http://hdl.handle.net/20.500.11937/3222 |
| _version_ | 1848744172458082304 |
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| author | Payne, D. Baluchova, K. Peoc'h, K. van Schaik, R. Chan, K. Maekawa, M. Mamotte, Cyril Russomando, G. Rousseau, F. Ahmad-Nejad, P. |
| author_facet | Payne, D. Baluchova, K. Peoc'h, K. van Schaik, R. Chan, K. Maekawa, M. Mamotte, Cyril Russomando, G. Rousseau, F. Ahmad-Nejad, P. |
| author_sort | Payne, D. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | © 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. |
| first_indexed | 2025-11-14T05:57:14Z |
| format | Journal Article |
| id | curtin-20.500.11937-3222 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T05:57:14Z |
| publishDate | 2015 |
| publisher | Elsevier BV |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-32222017-09-13T14:42:53Z Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach Payne, D. Baluchova, K. Peoc'h, K. van Schaik, R. Chan, K. Maekawa, M. Mamotte, Cyril Russomando, G. Rousseau, F. Ahmad-Nejad, P. © 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. 2015 Journal Article http://hdl.handle.net/20.500.11937/3222 10.1016/j.cca.2016.06.018 Elsevier BV restricted |
| spellingShingle | Payne, D. Baluchova, K. Peoc'h, K. van Schaik, R. Chan, K. Maekawa, M. Mamotte, Cyril Russomando, G. Rousseau, F. Ahmad-Nejad, P. Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach |
| title | Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach |
| title_full | Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach |
| title_fullStr | Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach |
| title_full_unstemmed | Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach |
| title_short | Pre-examination factors affecting molecular diagnostic test results and interpretation: A case-based approach |
| title_sort | pre-examination factors affecting molecular diagnostic test results and interpretation: a case-based approach |
| url | http://hdl.handle.net/20.500.11937/3222 |