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KMID : 1134120100130040366
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Journal of Breast Cancer
2010 Volume.13 No. 4 p.366 ~ p.374
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One-step Nucleic Acid Amplification (OSNA): Intraoperative Rapid Molecular Diagnostic Method for the Detection of Sentinel Lymph Node Metastases in Breast Cancer Patients in Korean Cohort
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Choi Yoon-La
Ahn Soo-Kyung
Bae Young-Kyung
Park In-Ae
Min Jun-Won
Lee Kyu-Won
Bae Jin-Hye
Han Won-Shik
Choi Jung-Eun
Cho Eun-Yoon
Kim Sang-Min
Lee Hye-Sook
Nam Seok-Jin
Lee Jeong-Eon
Lee Soo-Jung
Noh Dong-Young
Yang Jung-Hyun
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Abstract
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Purpose: Sentinel lymph node (SLN) biopsy has become a standard procedure in breast cancer patient management. Accurate intraoperative assessment of metastasis of SLNs is essential for appropriate selection to avoid unnecessary axillary dissection. The aim of this study was to evaluate the performance of one-step nucleic acid amplification (OSNA) assay for detection of sentinel lymph node metastasis examination in breast cancer patients.
Methods: In this study, we compared intraoperative OSNA to histological investigation with multi-level observation in 284 sentinel lymph nodes of 199 patients. Surgically obtained sentinel lymph nodes were sectioned into 2 mm intervals of up to four pieces, half of which were examined with the OSNA assay. The other half of adjacent pieces were histopathologically examined both intraoperatively and postoperatively. The presence/absence of metastases was judged by observing hematoxylin and eosin staining and cytokeratin (AE1/ AE3) immunohistochemically stained multiple slides from one lymph node.
Results: Among 199 patients included, 36 cases were positive on histological examination and 34 cases were positive on OSNA assay. There were 14 discordant cases. The overall concordance with histology was 93.0% (95% confidence interval [CI], 0.86-0.96), with a sensitivity of 77.8% (95% CI, 0.61-0.90), specificity of 96.3% (95% CI, 0.92-0.99), positive predictive value of 82.4% (95% CI, 0.65-0.93) and negative predictive value of 95.2% (95% CI, 0.91-0.98). The kappa statistic analysis indicated substantial agreement of both methods, with a value of 0.76 (95% CI, 0.64-0.88). The average turnaround time was 39.0 minutes.
Conclusion: The results of this study indicate that the OSNA assay has equivalent accuracy to histopathology in detecting breast cancer metastasis to lymph nodes when each method is assigned two alternate blocks of four blocks sectioned at 2 mm intervals.
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KEYWORD
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Breast neoplasms, Molecular diagnostic techniques, Sentinel lymph node biopsy
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