{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T21:40:13Z","timestamp":1785015613832,"version":"3.55.0"},"reference-count":159,"publisher":"National Institute for Health and Care Research","issue":"2","license":[{"start":{"date-parts":[[2015,1,1]],"date-time":"2015-01-01T00:00:00Z","timestamp":1420070400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000276","name":"National Institute for Health Research","doi-asserted-by":"publisher","award":["12\/14\/01"],"award-info":[{"award-number":["12\/14\/01"]}],"id":[{"id":"10.13039\/501100000276","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title><jats:p>In breast cancer patients, sentinel lymph node biopsy is carried out at the same time as the removal of the primary tumour to postoperatively test with histopathology for regional metastases in the sentinel lymph node. Those patients with positive test results are then operated on 2\u20134 weeks after primary surgery to remove the lymph nodes from the axilla (axillary lymph node dissection, ALND). New molecular tests RD-100i [one-step nucleic acid amplification (OSNA); based on messenger RNA amplification to identify the cytokeratin-19 (<jats:italic>CK19<\/jats:italic>) gene marker] (Sysmex, Norderstedt, Germany) and Metasin (using the<jats:italic>CK19<\/jats:italic>and mammaglobin gene markers) (Cellular Pathology, Princess Alexandra Hospital NHS Trust, Harlow, UK) are intended to provide an intraoperative diagnosis, thereby avoiding the need for postoperative histopathology and, in positive cases, a second operation for ALND.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-2\"><jats:title>Objective<\/jats:title><jats:p>To evaluate the clinical effectiveness and cost-effectiveness of using OSNA and Metasin in the NHS in England for the intraoperative diagnosis of sentinel lymph nodes metastases, compared with postoperative histopathology, the current standard.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-3\"><jats:title>Data sources<\/jats:title><jats:p>Electronic databases including MEDLINE, MEDLINE In-Process &amp; Other Non-Indexed Citations, EMBASE, The Cochrane Library and the Health Economic Evaluations Database as well as clinical trial registries, grey literature and conference proceedings were searched up to July 2012.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-4\"><jats:title>Review methods<\/jats:title><jats:p>A systematic review of the evidence was carried out using standard methods. Single-gate studies were used to estimate the accuracy of OSNA with histopathology as the reference standard. The cost-effectiveness analysis adapted an existing simulation model of the long-term costs and health implications of early breast cancer diagnostic outcomes. The model accounted for the costs of an extended first operation with intraoperative testing, the loss of health-related quality of life (disutility) from waiting for postoperative test results, disutility and costs of a second operation, and long-term costs and disutility from lymphoedema related to ALND, adjuvant therapy, locoregional recurrence and metastatic recurrence.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-5\"><jats:title>Results<\/jats:title><jats:p>A total of 724 references were identified in the searches, of which 17 studies assessing test accuracy were included in the review, 15 on OSNA and two on Metasin. Both Metasin studies were unpublished. OSNA sensitivity of 84.5% [95% confidence interval (CI) 74.7% to 91.0%] and specificity of 91.8% (95% CI 87.8% to 94.6%) for patient nodal status were estimated in a meta-analysis of five studies [unadjusted for tissue allocation bias (TAB)]. At these values and a 20% node-positive rate, OSNA resulted in lifetime discounted cost-savings of \u00a3498 and a quality-adjusted life-year (QALY) loss of 0.048 relative to histopathology, that is, \u00a34324 saved per QALY lost. The most favourable plausible scenario for OSNA in terms of the node-positive rate (range 10\u201340%), diagnostic accuracy values (91.3% sensitivity and 94.2% specificity, from three reports that adjusted for TAB), the costs of histopathology, OSNA and second surgery, and long-term costs and utilities resulted in a maximum saving per QALY lost of \u00a310,500; OSNA sensitivity and specificity would need to be \u2265\u200995% for this figure to be \u2265\u2009\u00a320,000.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-6\"><jats:title>Limitations<\/jats:title><jats:p>There is limited evidence on the diagnostic test accuracy of intraoperative tests. The quality of information on costs of resource utilisation during the diagnostic pathway is low and no evidence exists on the disutility of waiting for a second surgery. No comparative studies exist that report clinical outcomes of intraoperative diagnostic tests. These knowledge gaps have more influence on the decision than current uncertainty in the performance of postoperative histopathology in standard practice.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-7\"><jats:title>Conclusions<\/jats:title><jats:p>One-step nucleic acid amplification is not cost-effective for the intraoperative diagnosis of sentinel lymph node metastases. OSNA is less accurate than histopathology and the consequent loss of health benefits in this patient group is not compensated for by health gains elsewhere in the health system that may be obtained with the cost-savings made. The evidence on Metasin is insufficient to evaluate its cost-effectiveness.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-8\"><jats:title>Study registration<\/jats:title><jats:p>This study is registered as PROSPERO CRD42012002889.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-9\"><jats:title>Funding<\/jats:title><jats:p>The National Institute for Health Research Health Technology Assessment programme.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta19020","type":"journal-article","created":{"date-parts":[[2015,1,15]],"date-time":"2015-01-15T10:12:05Z","timestamp":1421316725000},"page":"1-216","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":28,"title":["A systematic review and economic evaluation of intraoperative tests [RD-100i one-step nucleic acid amplification (OSNA) system and Metasin test] for detecting sentinel lymph node metastases in breast cancer"],"prefix":"10.3310","volume":"19","author":[{"given":"Nicola","family":"Huxley","sequence":"first","affiliation":[{"name":"Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tracey","family":"Jones-Hughes","sequence":"additional","affiliation":[{"name":"Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Coelho","sequence":"additional","affiliation":[{"name":"Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tristan","family":"Snowsill","sequence":"additional","affiliation":[{"name":"Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Cooper","sequence":"additional","affiliation":[{"name":"Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yang","family":"Meng","sequence":"additional","affiliation":[{"name":"School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Hyde","sequence":"additional","affiliation":[{"name":"Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rub\u00e9n","family":"M\u00fajica-Mota","sequence":"additional","affiliation":[{"name":"Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School, Exeter, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2015,1]]},"reference":[{"key":"key2015011408264027_ref1-bib1","doi-asserted-by":"publisher","first-page":"208","DOI":"10.1111\/j.1582-4934.2005.tb00350.x","article-title":"Understanding breast cancer risk \u2013 where do we stand in 2005?","volume":"9","author":"Dumitrescu","year":"2005","journal-title":"J Cell Mol Med"},{"key":"key2015011408264027_ref1-bib2","unstructured":"Office for National Statistics. 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