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A validation study for the use VE1 immunohistochemical staining in screening for BRAF mutation in cutaneous malignant melanoma

Weiming Zhang, Guoxin Song, Xue Han, Xiao Li, Dan Luo

BRAF V600E mutation analysis has been an important companion diagnostic assay to evaluate prognosis of malignant melanoma and to guide target therapy with BRAF inhibitor. The aim of this study was to assess the sensitivity and specificity of Immunohistochemistry (IHC) using VE1 mutation specific antibody on screening for BRAF V600E mutation patients with cutaneous malignant melanoma. We detected BRAF V600E mutation on a total of 90 formalin-fixed paraffin-embedded melanoma tissue samples by ARMS-PCR and immunohistochemistry simultaneously. The results obtained from ARMS were set as a diagnostic gold standard; IHC staining with BRAF V600E mutation-specific antibody displayed 100% sensitivity and 96.8% specificity. Further statistical analysis showed that results from the two methods were consistent (kappa=0.948 p<0.001), Positive Predictive Value (PPV) and Negative Predictive Value (NPV) were 93.1%and 100%. Therefore, as a simple, fast and low cost method, IHC can be used as a routine screening method for BRAF V600E mutation analysis in cutaneous malignant melanoma.