NEW YORK (360Dx) – Laboratories participating in BRAF proficiency testing through the College of American Pathologists are reporting most of the required information, but still have room for improvement, according to a recently published analysis.
Overall, researchers said that laboratories participating in BRAF proficiency testing through CAP include most of the required reporting elements "to unambiguously convey molecular results," and but they "should continue to strive to report these results in a concise and comprehensive manner."
Published in the Archives of Pathology and Laboratory Medicine, the report set out to examine whether laboratories followed CAP instructions in reporting required information to clinicians and patients. The researchers examined the reporting of basic information, such as the name of the facility, the date that a patient specimen was collected, and the specimen type.
Additionally, it looked at which technologies the labs used and whether they adequately defined the targets of their assays.
The researchers looked at a total of 107 evaluable reports — 57 demonstrating positive results for the BRAF V600E mutation, and 50 negative. Among the more notable findings: PCR with probe discrimination was the most common method used for mutation detection, followed by Sanger sequencing, allele-specific primers, and pyrosequencing. Only two of the reports documented use of next-generation sequencing.
Ninety-five percent of the reports clearly described the technologies that were used in the proficiency testing, while 87 percent adequately defined the targets of all BRAF assays they described "such as the nucleotide positions within the gene, or the codon positions for the predicted amino acid."
But just 34 percent of the reports included a statement of clinically significant variants detected by the assay that were used by the labs, although the CAP Molecular Pathology Check List "specifically recommends" including such a statement, the researchers said.
They wrote that 94 percent of the reports (100 labs) used only a laboratory-developed assay for their proficiency testing, while the remaining 6 percent (seven labs) used the Roche Cobas 4800 BRAF V600 Mutation Test approved by the US Food and Drug Administration.
However, only 12 percent of the labs using an LDT included any information about the development of the assay or the fact that it was not cleared by the FDA, though "[i]t should be mentioned that participating laboratories outside the United States are subject to different regulations and FDA guidance than are US testing laboratories."
The authors said that because the reports were de-identified, they could not separate the US from the non-US laboratories whose reports were evaluated.
Further, they said that though LDTs must document appropriate methods and performance characteristics, 30 percent of the reports containing "LDT language" did not contain all necessary components.
And overall, just 15 percent of the 107 reports included all elements that are explicitly required in CAP's checklist evaluated in the study, the authors noted.
"While the requirements discussed [in the report] may seem extensive, all report components can be easily included with clear and concise wording," they said.