Detection of lymph node metastasis in lung cancer patients using a one-step nucleic acid amplification assay: a single-centre prospective study

Abstract

Background The use of one-step nucleic acid amplification (OSNA) allows for lymph node (LN) metastasis to be detected rapidly and accurately. We conducted a prospective single-centre clinical trial to evaluate OSNA assay in detecting LN metastasis of lung cancer. Patients and methods A total of 705 LNs from 160 patients with clinical stage IA to IVA lung cancer were included in this study. The LNs were divided and submitted to routine histological diagnosis and OSNA assay and the results were compared. We also examined keratin 19 expression of different histological types lung primary tumours. Results When the cut-off value was set to 250 copies/µl, the concordance rate between the two methods was 96.17% and the sensitivity 97.14%. Discordant results were observed in 27 LNs of 21 patients. Most of these discordant results were molecular micrometastasis expressing a very low number of copies with negative histology. Most thoracic tumours were positive for keratin 19. Conclusions Our data show that the OSNA assay might be a useful and sensitive method to diagnose LN metastasis in lung cancer and could be applied to intraoperative decision-making in personalised lung cancer surgery based on LN status and a more accurate staging of patients.

Detection of lymph node metastasis in non-small cell lung cancer using the new system of one-step nucleic acid amplification assay

“…The discordant cases determined through histological examination consisted of 13 false-positive and 3 false-negative specimens. The concordance rate, sensitivity, and specificity of the new system relative to histopathology were equivalent to those of the conventional system, as shown in the current reports [ 7 , 8 ]. Compared with the conventional system, the concordance rate, sensitivity, specificity, PPV, and NPV of the new system were 95.0% (95% CI: 91.0%–97.3%), 86.4% (95% CI: 73.3%–93.6%), 97.4% (95% CI: 93.5%–99.0%), 90.5% (95% CI: 78.2%–96.2%), and 96.2% (95% CI: 91.9%–98.2%), respectively.…”

Application of One-Step Nucleic Acid Amplification (OSNA) in different cancer entities and usefulness in prostate cancer: a systematic review

“…The 25 eligible studies have been published between January 2007 and March 2021. Our review included SLN and non-SLN from six different groups of tumours: 1) breast [ 15 , 28 – 34 ], 2) gastrointestinal —colorectal [ 35 – 38 ] and gastric cancers [ 39 – 41 ]—, 3) gynecological —cervical [ 42 ] and endometrial cancers [ 43 – 45 ]—, 4) lung [ 46 – 48 ], 5) head and neck —head and neck squamous cell carcinomas (HNSCC) [ 49 ] and thyroid cancers [ 50 ]— and 6) PCa [ 24 ]. All studies were prospectively designed.…”

“…As CK19 is the single molecular marker used in OSNA assay, low tumour CK19 expression may result in a false-negative OSNA case. Different CK19 expression levels have been described for other malignancies such as colorectal (94.1%) [ 36 ], gastric (98.6%) [ 39 ], gynecological (98%) [ 43 ], lung (96%) [ 48 ], HNSCC (91.1%) [ 49 ] or PCa (100%) [ 23 ]. Moreover, certain tumour subtypes are more likely to the lack of CK19 expression, as observed in metaplastic and lobular breast carcinomas [ 56 ].…”

“…Interestingly, Goda et al [ 49 ] performed a CK19 IHC in primary HNSCC as a first step when analyzing discordant results, detecting no expression of CK19 in 75% of those cases. Aiming to reduce false-negative cases in breast, thyroid and lung carcinomas, Vegué et al [ 30 ], del Carmen et al [ 50 ], and Escalante Pérez et al [ 48 ] verified the presence of CK19 in primary tumour by IHC before LN analysis. For a more accurate interpretation of the results, we encourage future researchers to include CK19 expression in primary tumours as patient inclusion criteria.…”

The Diagnostic Accuracy of One-Step Nucleic Acid Amplification for Lymph Node Metastases of Papillary Thyroid Carcinoma： A Systematic Review and Meta-Analysis

“…One-step nucleic acid amplification (OSNA) is a rapid and precise molecular diagnostic method based on reverse transcription loop-mediated isothermal amplification of cytokeratin 19 (CK19) mRNA. Recently, it has been introduced for intraoperative analysis of lymph node involvement in many tumors such as breast cancer ( 14 ), colorectal cancer ( 15 ), lung cancer ( 16 ), and endometrial cancer ( 17 ). It is known that about 70% of all PTCs have an intense CK19 expression at the membrane level, and that positive expression can also be seen in metastatic cells within the lymph nodes ( 18 ).…”