title: [Prospective multi-center study of one-step nucleic acid amplification assay for the detection of sentinel lymph nodes metastases in breast cancer patients].
abstract: OBJECTIVE
  To evaluate the roles of Sysmex RD100i one-step nucleic acid amplification (OSNA) assay in the intraoperative assessments of breast cancer sentinel lymph nodes (SLNs).
  
  
  METHODS
  A total of 552 consecutive prospective patients were enrolled from five centers nationwide from February to December 2010. And SLNs were sliced into alternating 2 mm blocks. The odd blocks were tested by the OSNA assay intraoperatively and the even ones assessed by postoperative histology. In addition, intraoperative histological assessments were performed on the even blocks of 211 patients by frozen section and all blocks by touch imprint cytology.
  
  
  RESULTS
  A total of 1188 SLNs were removed. The mean turnaround time of the assay was 37.3 min. There was no significant difference of turnaround time at each center (P = 0.074). As compared to postoperative histology, the overall performance of the assay had an accuracy of 91.4% (1086/1188), a sensitivity of 83.7% (159/190) and a specificity of 92.9% (927/998). The sensitivity of the assay was higher than frozen section (77.6% (59/76) vs 69.7% (53/76), P = 0.286) and was significantly higher than touch imprint cytology (83.6% (158/189) vs 76.2% (144/189), P = 0.044). For nodes with micro-metastases, the sensitivity of the assay was higher than frozen section (8/17 vs 4/17, P = 0.289) and was significantly higher than touch imprint cytology (62.5% (30/48) vs 35.4% (17/48), P = 0.007).
  
  
  CONCLUSIONS
  As an accurate and rapid intraoperative assay for assessing breast SLNs, the OSNA assay may replace frozen section and touch imprint cytology for clinical applications.
authors.affiliation: Breast Cancer Center, Shandong Cancer Hospital & Institute, Jinan 250117, China. wangysh2008@yahoo.com.cn
authors.forename: Yong-sheng
authors.initials: YS
authors.lastname: Wang
authors.forename: Tao
authors.initials: T
authors.lastname: Ouyang
authors.forename: Jiong
authors.initials: J
authors.lastname: Wu
authors.forename: Yan-hui
authors.initials: YH
authors.lastname: Liu
authors.forename: Xu-chen
authors.initials: XC
authors.lastname: Cao
authors.forename: Xiao
authors.initials: X
authors.lastname: Sun
authors.forename: Li
authors.initials: L
authors.lastname: Fu
authors.forename: Ning
authors.initials: N
authors.lastname: Liao
authors.forename: Wen-tao
authors.initials: WT
authors.lastname: Yang
authors.forename: Wei-xia
authors.initials: WX
authors.lastname: Zhong
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000473:pathology; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis / Q000175:diagnosis* / Q000473:pathology; D008875:Middle Aged; D009367:Neoplasm Staging; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy