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Updated: Mar 3, 2026
Employing Digital Droplet PCR to Detect BRAF V600E Mutations in Formalin-fixed Paraffin-embedded Reference Standard Cell Lines
Published on: October 8, 2015
Reporting Results of Molecular Tests: A Retrospective Examination of BRAF Mutation Reporting
Amanda L Treece, Margaret L Gulley, Patricia Vasalos
1From the Department of Pathology, University of Colorado Anschutz Medical Campus, Aurora (Dr Treece); the Department of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill (Dr Gulley); College of American Pathologists, Northfield, Illinois (Ms Vasalos); the Department of Pathology, Warren Alpert Medical School of Brown University, Providence, Rhode Island (Dr Paquette); the Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts (Dr Lindeman); the Department of Pathology, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois (Dr Jennings); and the Department of Pathology and Laboratory Medicine, St. Joseph Mercy Hospital, Ann Arbor, Michigan (Dr Bartley).
Context:
- With enormous growth in the field of molecular pathology, the reporting of results gleaned from this testing is essential to guide patient care.
Objective:
- To examine molecular reports from laboratories participating in proficiency testing for required elements to convey molecular laboratory test results to clinicians and patients.
Design:
- Molecular laboratories participating in the College of American Pathologists (CAP) proficiency testing program for BRAF mutation analysis were solicited to submit examples of final reports from 2 separate proficiency testing reporting cycles. Reports were reviewed for the presence or absence of relevant components.
Results:
- A total of 107 evaluable reports were received (57 demonstrating a positive result for the BRAF V600E mutation and 50 negative). Methods for BRAF testing varied, with 95% (102 of 107) of reports adequately describing their assay methods and 87% (93 of 107) of reports adequately describing the target(s) of their assays. Information on the analytic sensitivity of the assay was present in 74% (79 of 107) of reports and 83% (89 of 107) reported at least 1 assay limitation, though only 34% (36 of 107) reported on variants not detected by their assays. Analytic and clinical interpretive comments were included in 99% (106 of 107) and 90% (96 of 107) of reports, respectively. Of participants that perform a laboratory-developed test, 88% (88 of 100) included language addressing the development of the assay.
Conclusions:
- Laboratories participating in BRAF proficiency testing through the CAP are including most of the required reporting elements to unambiguously convey molecular results. Laboratories should continue to strive to report these results in a concise and comprehensive manner.
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