To evaluate the performance of B-rapidly accelerated fibrosarcoma(BRAF) gene mutation detection in 2017 external assessment(EQA) program, analyze the existing problems in clinical laboratories and put forward the suggestions for improvement measures.

The Shanghai clinical laboratory center (hereinafter referred to as the ″center″) sent two EQA sample plates to 45 laboratories in 2017 for BRAF detetection, each containing 5 samples. Forty-five participating laboratories were asked to upload the results to the center database within one week. Then according to the return results, the center summarized the EQA scores of each laboratory, and calculated the coincidence rate of each sample.

The two BRAF mutation detection EQA activities received 42 and 41 laboratories valid returns respectively. The coincidence rates of each sample in the two EQA activities were from 76.2% to 100%, and the overall coincidence rates of wild type samples, p.V600K samples, p.V600R samples and p.V600E samples were 99.2% (123/124), 79.8% (67/84), 87.8% (36/41) and 95.2% (119/125), respectively. 73.8% (31/42) and 75.6% (31/41) of the laboratories submitted correct results for all samples. Among them, 79.8% (27/34) and 81.3% (26/32) of the laboratories obtained completely correct results using the registered reagent, while only 50% (4/8) and 55.6%(5/9) laboratories obtained completely correct results using lab-developed tests (LDTs).

The total coincidence rate of the BRAF gene mutation detection in the clinical laboratories of Shanghai is relative high in the 2017 EQA programs, and the coincidence rates of the test results are higher in laboratories using registered reagents than in the laboratories using LDTs. The testing ability of some laboratories should be improved, and the quality control of the BRAF mutation detection should be strengthened so as to ensure the accuracy of the test results.