دورية أكاديمية
SPOT/Dx Pilot Reanalysis and College of American Pathologists Proficiency Testing for KRAS and NRAS Demonstrate Excellent Laboratory Performance.
| العنوان: | SPOT/Dx Pilot Reanalysis and College of American Pathologists Proficiency Testing for KRAS and NRAS Demonstrate Excellent Laboratory Performance. |
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| المؤلفون: | Zehir A; From the Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York (Zehir)., Nardi V; the Department of Pathology, Massachusetts General Hospital, Mass General Brigham, Harvard Medical School, Boston (Nardi)., Konnick EQ; the Department of Laboratory Medicine and Pathology, University of Washington, Seattle (Konnick, Lockwood)., Lockwood CM; the Department of Laboratory Medicine and Pathology, University of Washington, Seattle (Konnick, Lockwood)., Long TA; Biostatistics (Long, Souers) Departments, College of American Pathologists, Northfield, Illinois., Sidiropoulos N; Pathology and Laboratory Medicine, University of Vermont Medical Center, Larner College of Medicine at the University of Vermont, Burlington (Sidiropoulos)., Souers RJ; Biostatistics (Long, Souers) Departments, College of American Pathologists, Northfield, Illinois., Vasalos P; Proficiency Testing (Vasalos) Departments, College of American Pathologists, Northfield, Illinois., Lindeman NI; the Department of Pathology, Weill Cornell Medicine, New York, New York (Lindeman)., Moncur JT; the Office of the Director, The Joint Pathology Center, Silver Spring, Maryland (Moncur). |
| المصدر: | Archives of pathology & laboratory medicine [Arch Pathol Lab Med] 2024 Feb 01; Vol. 148 (2), pp. 139-148. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: College of American Pathologists Country of Publication: United States NLM ID: 7607091 Publication Model: Print Cited Medium: Internet ISSN: 1543-2165 (Electronic) Linking ISSN: 00039985 NLM ISO Abbreviation: Arch Pathol Lab Med Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Northfield, Ill. : College of American Pathologists Original Publication: Chicago, American Medical Assn. |
| مواضيع طبية MeSH: | Laboratories* , Proto-Oncogene Proteins p21(ras)*/genetics, Humans ; Pathologists ; Pilot Projects ; Laboratory Proficiency Testing/methods ; Membrane Proteins ; GTP Phosphohydrolases/genetics |
| مستخلص: | Context.—: The Sustainable Predictive Oncology Therapeutics and Diagnostics quality assurance pilot study (SPOT/Dx pilot) on molecular oncology next-generation sequencing (NGS) reportedly demonstrated performance limitations of NGS laboratory-developed tests, including discrepancies with a US Food and Drug Administration-approved companion diagnostic. The SPOT/Dx pilot methods differ from those used in proficiency testing (PT) programs. Objective.—: To reanalyze SPOT/Dx pilot data using PT program methods and compare to PT program data.Also see p. 136. Design.—: The College of American Pathologists (CAP) Molecular Oncology Committee reanalyzed SPOT/Dx pilot data applying PT program methods, adjusting for confounding conditions, and compared them to CAP NGS PT program performance (2019-2022). Results.—: Overall detection rates of KRAS and NRAS single-nucleotide variants (SNVs) and multinucleotide variants (MNVs) by SPOT/Dx pilot laboratories were 96.8% (716 of 740) and 81.1% (129 of 159), respectively. In CAP PT programs, the overall detection rates for the same SNVs and MNVs were 97.2% (2671 of 2748) and 91.8% (1853 of 2019), respectively. In 2022, the overall detection rate for 5 KRAS and NRAS MNVs in CAP PT programs was 97.3% (1161 of 1193). Conclusions.—: CAP PT program data demonstrate that laboratories consistently have high detection rates for KRAS and NRAS variants. The SPOT/Dx pilot has multiple design and analytic differences with established PT programs. Reanalyzed pilot data that adjust for confounding conditions demonstrate that laboratories proficiently detect SNVs and less successfully detect rare to never-observed MNVs. The SPOT/Dx pilot results are not generalizable to all molecular oncology testing and should not be used to market products or change policy affecting all molecular oncology testing. (© 2024 College of American Pathologists.) |
| المشرفين على المادة: | EC 3.6.5.2 (Proto-Oncogene Proteins p21(ras)) 0 (KRAS protein, human) EC 3.6.1.- (NRAS protein, human) 0 (Membrane Proteins) EC 3.6.1.- (GTP Phosphohydrolases) |
| تواريخ الأحداث: | Date Created: 20230930 Date Completed: 20240131 Latest Revision: 20240131 |
| رمز التحديث: | 20240131 |
| DOI: | 10.5858/arpa.2023-0322-CP |
| PMID: | 37776255 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1543-2165 |
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| DOI: | 10.5858/arpa.2023-0322-CP |