BRAF(V600E) mutation has been investigated by immunohistochemistry and has shown high sensitivity and specificity. We aim to investigate the accuracy of immunohistochemistry versus molecular testing of BRAF(V600E) in papillary thyroid cancer using a large number of polymerase chain reaction-positive BRAF(V600E) papillary thyroid cancer tissues.

We stained 130 formalin-fixed papillary thyroid cancer specimens using the VE1 antibody: 100 BRAF(V600E) positive and 30 BRAF(V600E) negative confirmed by PCR. The sensitivity, specificity, and predictive values of the antibody were assessed.

Immunohistochemistry of BRAF(V600E) showed 98.0% sensitivity, 93.3% specificity, and positive and negative predictive values of 98.0% and 93.3%, respectively. Of 100 patients with BRAF(V600E) PCR-positive samples, 97 (97.0%) had cytoplasmic weak (4.0%), moderate (17.0%), and strong (76.0%) immunostaining. In BRAF(V600E) PCR-negative samples, cytoplasmic staining was not detected in 93.3% (28/30) of papillary thyroid cancer tissues. The receiver operating characteristic curve demonstrated a high validity and comparable immunohistochemistry method (area under the curve = 98.8%) compared with PCR testing.

The use of VE1 immunohistochemistry for the detection of BRAF(V600E) in papillary thyroid cancer tissues is a clinically applicable method with high specificity, sensitivity, and positive and negative predictive values. The reliable use of BRAF(V600E) immunohistochemistry should promulgate the routine use of this method for BRAF(V600E) detection in papillary thyroid cancer tissues.