title: Comparative Study of the One-step Nucleic Acid Amplification Assay and Conventional Histological Examination for the Detection of Breast Cancer Sentinel Lymph Node Metastases.
abstract: Intraoperative sentinel lymph node (SLN) biopsy is widely used in patients with early-stage breast cancer and is conventionally performed using hematoxylin and eosin-based histological examination. The one-step nucleic acid amplification (OSNA) assay is a molecular diagnostic tool and a semi-automated lymph node examination method. The purpose of this study was to compare the performance of the OSNA assay and conventional histological examination with frozen sections (FSs) by using 111 SLN biopsy samples from 89 patients at the Tokai University Hospital. The SLN samples were split into 3 slices: the middle slice was used for FS histological examination and the other slices were used for the OSNA assay. The McNemar test was used to compare the differences in the sensitivity and specificity between the OSNA assay and FS histological examination. The sensitivity of the OSNA assay (97.1%) was less than that of FS histological examination (100%), but this difference was not statistically significant (P = 0.125). The specificity of both the methods was identical (96.9%). Despite previously published results suggesting that the OSNA assay is as reliable as histological examinations, our results indicate that this assay often fails to detect micrometastases or isolated tumor cells in SLNs.
authors.forename: Mizuho
authors.initials: M
authors.lastname: Terada
authors.affiliation: Department of Breast and Endocrine Surgery, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan. niikura@is.icc.u-tokai.ac.jp.
authors.forename: Naoki
authors.initials: N
authors.lastname: Niikura
authors.forename: Banri
authors.initials: B
authors.lastname: Tsuda
authors.forename: Shinobu
authors.initials: S
authors.lastname: Masuda
authors.forename: Nobue
authors.initials: N
authors.lastname: Kumaki
authors.forename: Xiaoyan
authors.initials: X
authors.lastname: Tang
authors.forename: Takuho
authors.initials: T
authors.lastname: Okamura
authors.forename: Yuki
authors.initials: Y
authors.lastname: Saito
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Suzuki
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tokuda
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000473:pathology; D004801:Eosine Yellowish-(YS); D005260:Female; D005629:Frozen Sections; D006416:Hematoxylin; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*
chemical_list: D004801:Eosine Yellowish-(YS); D006416:Hematoxylin