Reporting results of molecular tests: A retrospective examination of BRAF mutation reporting

Amanda L. Treece, Margaret L. Gulley, Patricia Vasalos, Cherie Paquette, Neal I. Lindeman, Lawrence J Jennings, Angela N. Bartley*

*Corresponding author for this work

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)658-665
Number of pages8
JournalArchives of Pathology and Laboratory Medicine
Volume141
Issue number5
DOIs
StatePublished - May 1 2017

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Mutation
Language Development
Molecular Pathology
Patient Care
Growth
Pathologists

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology

Cite this

Treece, Amanda L. ; Gulley, Margaret L. ; Vasalos, Patricia ; Paquette, Cherie ; Lindeman, Neal I. ; Jennings, Lawrence J ; Bartley, Angela N. / Reporting results of molecular tests : A retrospective examination of BRAF mutation reporting. In: Archives of Pathology and Laboratory Medicine. 2017 ; Vol. 141, No. 5. pp. 658-665.
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abstract = "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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Reporting results of molecular tests : A retrospective examination of BRAF mutation reporting. / Treece, Amanda L.; Gulley, Margaret L.; Vasalos, Patricia; Paquette, Cherie; Lindeman, Neal I.; Jennings, Lawrence J; Bartley, Angela N.

In: Archives of Pathology and Laboratory Medicine, Vol. 141, No. 5, 01.05.2017, p. 658-665.

Research output: Contribution to journalArticle

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T2 - A retrospective examination of BRAF mutation reporting

AU - Treece, Amanda L.

AU - Gulley, Margaret L.

AU - Vasalos, Patricia

AU - Paquette, Cherie

AU - Lindeman, Neal I.

AU - Jennings, Lawrence J

AU - Bartley, Angela N.

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N2 - 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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