Anastasios Tranoulis1, Dimitra Georgiou2, Jason Yap3, Stephen Attard-Montalto4, Jeremy Twigg5, Ahmed Elattar6, Kavita Singh6, Janos Balega6, Sean Kehoe3. 1. Department of Gynaecological Oncology, The Pan-Birmingham Gynaecological Cancer Centre, Sandwell and West Birmingham NHS Trust, Birmingham, UK. Electronic address: tasostranoulis@yahoo.com. 2. Department of Gynaecological Oncology, Chelsea and Westminster NHS Foundation Trust, Imperial College, London, UK. 3. Department of Gynaecological Oncology, The Pan-Birmingham Gynaecological Cancer Centre, Sandwell and West Birmingham NHS Trust, Birmingham, UK; Institute of Cancer and Genomic Sciences, University of Birmingham, UK. 4. Department of Gynaecological Oncology, Maidstone and Tunbridge Wells NHS Trust, Maidstone, UK. 5. Department of Gynaecological Oncology, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK. 6. Department of Gynaecological Oncology, The Pan-Birmingham Gynaecological Cancer Centre, Sandwell and West Birmingham NHS Trust, Birmingham, UK.
Abstract
BACKGROUND: One Step Nucleic Acid Amplification (OSNA) assay has recently emerged as a rapid molecular diagnostic tool for the detection of lymph node (LN) metastases. It is a molecular technique that analyses the entire LN tissue using a reverse-transcriptase loop-mediated isothermal amplification reaction to detect tumour specific cytoceratin 19 mRNA. AIM: To ascertain the diagnostic accuracy of OSNA assay in detecting LN metastases amongst different types of malignancy. DESIGN: We systematically searched MEDLINE, SCOPUS, ClinicalTrials.gov, and Cochrane Database, from inception up to August 2020. Quality assessment was performed using the Modified Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2). We calculated pooled diagnostic indices using the random-effects model. Meta-regression and sub-group analyses were performed to address heterogeneity. RESULTS: 31 studies were included in this meta-analysis, including four different types of cancer. The risk of bias and the overall quality of included studies was moderate to high. There was no evidence of publication bias. The pooled diagnostic odds ratio (DOR) for detecting LN metastases in gynaecological, head & neck/thyroid, gastrointestinal and lung cancer were 100.38, 76.17, 275.14, and 305.84, respectively. CONCLUSIONS: Our findings suggest that OSNA assay had a high diagnostic accuracy in detecting metastatic LNs in different types of malignancy. This evidence is constrained by the limited studies available for few tumour types and the rather high heterogeneity for few outcomes.
BACKGROUND: One Step Nucleic Acid Amplification (OSNA) assay has recently emerged as a rapid molecular diagnostic tool for the detection of lymph node (LN) metastases. It is a molecular technique that analyses the entire LN tissue using a reverse-transcriptase loop-mediated isothermal amplification reaction to detect tumour specific cytoceratin 19 mRNA. AIM: To ascertain the diagnostic accuracy of OSNA assay in detecting LN metastases amongst different types of malignancy. DESIGN: We systematically searched MEDLINE, SCOPUS, ClinicalTrials.gov, and Cochrane Database, from inception up to August 2020. Quality assessment was performed using the Modified Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2). We calculated pooled diagnostic indices using the random-effects model. Meta-regression and sub-group analyses were performed to address heterogeneity. RESULTS: 31 studies were included in this meta-analysis, including four different types of cancer. The risk of bias and the overall quality of included studies was moderate to high. There was no evidence of publication bias. The pooled diagnostic odds ratio (DOR) for detecting LN metastases in gynaecological, head & neck/thyroid, gastrointestinal and lung cancer were 100.38, 76.17, 275.14, and 305.84, respectively. CONCLUSIONS: Our findings suggest that OSNA assay had a high diagnostic accuracy in detecting metastatic LNs in different types of malignancy. This evidence is constrained by the limited studies available for few tumour types and the rather high heterogeneity for few outcomes.
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