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  • Archives of Pathology and Laboratory Medicine  (3)
  • 1
    Online Resource
    Online Resource
    Archives of Pathology and Laboratory Medicine ; 2009
    In:  Archives of Pathology & Laboratory Medicine Vol. 133, No. 5 ( 2009-05-01), p. 743-755
    In: Archives of Pathology & Laboratory Medicine, Archives of Pathology and Laboratory Medicine, Vol. 133, No. 5 ( 2009-05-01), p. 743-755
    Abstract: Context.—The use of DNA- and RNA-based tests continues to grow for applications as varied as inherited disease, infectious disease, cancer, identity testing, human leukocyte antigen typing, and pharmacogenetics. Progress is driven in part by the huge growth in knowledge about the molecular basis of disease coupled with advancements in technologic capabilities. In addition to requirements for clinical utility, every molecular test also may have limitations that must be carefully considered before clinical implementation. Analytic and clinical performance characteristics as well as test limitations are established and documented through the process of test validation. Objective.—To describe the established principles of test validation, along with relevant regulations in the United States, in order to provide a rational approach to introducing molecular tests into the clinical laboratory. Data Sources.—PubMed review of published literature, published guidelines, and online information from national and international professional organizations. Conclusions.—These resources and recommendations provide a framework for validating clinical tests.
    Type of Medium: Online Resource
    ISSN: 1543-2165 , 0003-9985
    RVK:
    RVK:
    Language: English
    Publisher: Archives of Pathology and Laboratory Medicine
    Publication Date: 2009
    detail.hit.zdb_id: 2028916-9
    Library Location Call Number Volume/Issue/Year Availability
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  • 2
    In: Archives of Pathology & Laboratory Medicine, Archives of Pathology and Laboratory Medicine, Vol. 131, No. 2 ( 2007-02-01), p. 185-189
    Abstract: Context.—The diagnosis of B-cell lymphoid malignancy can frequently be substantiated by detecting clonal immunoglobulin heavy chain (IGH) gene rearrangements, which is typically done by polymerase chain reaction (PCR) amplification and/or Southern blot analysis. Objective.—To characterize current laboratory practice for the assessment of IGH rearrangements and to identify opportunities for improvement. Design.—The data from the Molecular Oncology Proficiency Survey distributed to participating laboratories by the Molecular Pathology Committee of the College of American Pathologists from 1998 through 2003 were analyzed. Results.—Thirty-nine proficiency survey specimens (29 positive and 10 negative for clonal IGH rearrangements) were distributed. For Southern blot analysis, 944 results were reported, with a successful response rate of 95%. For PCR detection, 2349 results were reported, with a successful response rate of 72%. A higher rate of successful responses by PCR was achieved using framework 3 primers in combination with other frameworks (82%) compared with framework 3 primers only (76%) and when fresh/ frozen (72%) compared with paraffin-embedded (65%) tissues were analyzed. Conclusions.—The performance of the participating laboratories was very good, by both Southern blot and PCR analysis. As expected, Southern blot analysis consistently detects a higher proportion of IGH rearrangements than PCR analysis. Further improvement and standardization of the IGH PCR assay is important if it is to replace Southern blot analysis as the standard method. Participation in this survey is a valuable tool for assessing laboratory performance and it directs our attention to areas where we may improve laboratory practice.
    Type of Medium: Online Resource
    ISSN: 1543-2165 , 0003-9985
    RVK:
    RVK:
    Language: English
    Publisher: Archives of Pathology and Laboratory Medicine
    Publication Date: 2007
    detail.hit.zdb_id: 2028916-9
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
  • 3
    In: Archives of Pathology & Laboratory Medicine, Archives of Pathology and Laboratory Medicine, Vol. 131, No. 6 ( 2007-06-01), p. 852-863
    Abstract: Context.—Molecular pathology is a rapidly growing area of laboratory medicine in which DNA and RNA are analyzed. The recent introduction of array technology has added another layer of complexity involving massive parallel analysis of multiple genes, transcripts, or proteins. Objective.—As molecular technologies are increasingly implemented in clinical settings, it is important to bring uniformity to the way that test results are reported. Data Sources.—The College of American Pathologists Molecular Pathology Resource Committee members summarize elements that are already common to virtually all molecular pathology reports, as set forth in the College of American Pathologists checklists used in the laboratory accreditation process. Consensus recommendations are proposed to improve report format and content, and areas of controversy are discussed. Resources are cited that promote use of proper gene nomenclature and that describe methods for reporting mutations, translocations, microsatellite instability, and other genetic alterations related to inherited disease, cancer, identity testing, microbiology, and pharmacogenetics. Conclusions.—These resources and recommendations provide a framework for composing patient reports to convey molecular test results and their clinical significance to members of the health care team.
    Type of Medium: Online Resource
    ISSN: 1543-2165 , 0003-9985
    RVK:
    RVK:
    Language: English
    Publisher: Archives of Pathology and Laboratory Medicine
    Publication Date: 2007
    detail.hit.zdb_id: 2028916-9
    Library Location Call Number Volume/Issue/Year Availability
    BibTip Others were also interested in ...
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