Department of Pathology, Service d'Anatomie Pathologique, S Etienne University Hospital, St Etienne, France.
Anticancer Res. 2011 Feb;31(2):585-90.
Sentinel lymph node (SLN) biopsy is used as a staging procedure in early breast cancer, however, histology based intra-operative assessment of the SLN status has a low sensitivity. The one-step nucleic acid amplification (OSNA) method was developed to detect metastases by amplification of cytokeratin (CK) 19 mRNA. Experience with OSNA during a French multi-centric prospective study, as well as intra-operative clinical routine use, is reported.
For the clinical study 80 SLNs from 46 patients were assessed. During routine use, the central slice of the SLN from 197 patients was investigated by permanent histology and the remainder was assessed by OSNA.
During the clinical study, OSNA detected 15/17 metastases, including all the macrometastases, reaching a 96.3% concordance rate, 88.2% sensitivity and 98.4% specificity. During routine use, both OSNA and histology detected 25 patients with metastasis.
OSNA is an accurate tool for intra-operative assessment of SLN status and could reduce the need for second surgery.
前哨淋巴结（SLN）活检被用作早期乳腺癌的分期程序，然而，基于组织学的 SLN 状态术中评估具有较低的灵敏度。一步法核酸扩增（OSNA）方法是通过扩增细胞角蛋白（CK）19 mRNA 来检测转移的。报道了在法国多中心前瞻性研究期间以及术中临床常规使用中使用 OSNA 的经验。
为了进行临床研究，评估了 46 名患者的 80 个 SLN。在常规使用中，通过永久组织学检查了 197 名患者的 SLN 的中央切片，其余部分则通过 OSNA 进行评估。
在临床研究中，OSNA 检测到 15/17 个转移灶，包括所有的大转移灶，达到了 96.3%的一致性、88.2%的灵敏度和 98.4%的特异性。在常规使用中，OSNA 和组织学均检测到 25 名转移患者。
OSNA 是一种用于 SLN 状态术中评估的准确工具，可以减少二次手术的需要。
