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Objective To evaluate the application of GeneSearchTM breast lymph node assay in intraoperative detection of metastases in sentinel lymph node (SLN) from breast cancer patients. Methods A total of 225 SLN from 88 patients was prospectively studied. Each SLN was cut into 2 mm slabs which were examined by intraoperative imprint cytology (ⅡC) first, followed by GeneSearch assay and postoperative serial sectioning. GeneSearch used real-time fluorescence quantitative RT-PCR technology to detect the expression of CK19 and mammaglobin in SLN. The results of GeneSearch assay were correlated with those of ⅡC and post-operative serial sectioning. Results Amongst the 88 cases studied, 225 SLNs were found, and obvious metastatic carcinoma cells were identified in 27 SLNs and micrometastasis in 9 SLNs.One hundred and eight-nine SLNs were considered as "negative" (with "isolated tumor cells" present in 5 SLNs). The turn-around time of intraoperative GeneSearch assay ranged from 35 to 45 minutes (mean = 40 minutes). The concordance rate between GeneSearch assay and post-operative serial sectioning was 95.6% (215/225), with a sensitivity of 86.1% (31/36), compared with 94.7% (213/225) and 72.2% (26/36)respectively for ⅡC. The size of metastatic foci correlated with the Ct value of CK19 and mammaglobin (P <0.01). Conclusions GeneSearch assay for intraoperative detection of metastase in SLN has a satisfactory performance and demonstrates a relatively higher sensitivity than ⅡC. The potential clinical application still requires further evaluation of larger number of cases.  相似文献   
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