M Hirsch1, Jmn Duffy2,3, C J Davis4, M Nieves Plana5,6, K S Khan4. 1. Women's Health Research Unit, The Blizard Institute, Barts and the London School of Medicine and Dentistry, London, UK. m.hirsch@qmul.ac.uk. 2. Balliol College, University of Oxford, Oxford, UK. 3. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. 4. Women's Health Research Unit, The Blizard Institute, Barts and the London School of Medicine and Dentistry, London, UK. 5. Madrid Cochrane Collaboration Centre, Francisco de Vitoria University, Madrid, Spain. 6. Clinical Biostatistics Unit, Ramon y Cajal Institute of Research (IRYCIS) and CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain.
Abstract
BACKGROUND: The development of a non-invasive and accurate diagnostic biomarker for endometriosis is urgently needed. OBJECTIVE: Evaluate the diagnostic accuracy of serum cancer antigen 125 (CA 125) for endometriosis. SEARCH STRATEGY: We searched EMBASE, MEDLINE, and Web of Science from inception to January 2016. SELECTION CRITERIA: Diagnostic accuracy studies of serum CA 125 (index test) for histologically confirmed endometriosis (reference standard) were included. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials, extracted study characteristics and data. Methodological quality was assessed using Quality Assessment of Comparative Diagnostic Accuracy Studies (QUADAS-2) checklist. MAIN RESULTS: Twenty-two studies (16 cohort, six case-control), 3626 participants, were identified. Bivariate hierarchical models were used to pool accuracy data of 14 studies (2920 participants) using CA 125 ≥ 30 units/ml. Pooled specificity was 93% (95% CI 89-95%) and sensitivity 52% (95% CI 38-66%). CA 125 was significantly more sensitive for the diagnosis of moderate or severe endometriosis compared with minimal disease (63%, 95% CI 47-77% versus 24%, 95%CI 19-32%, P-value = 0.001). CONCLUSIONS: CA 125 performs well as a rule-in test facilitating expedited diagnosis and ensuring investigation and treatment can be confidently tailored for the management of endometriosis. Unfortunately, a negative test, CA 125 < 30 units/ml, is unable to rule out endometriosis. TWEETABLE ABSTRACT: Blood test CA 125: a rule-in test for the diagnosis of women presenting with symptoms of endometriosis.
BACKGROUND: The development of a non-invasive and accurate diagnostic biomarker for endometriosis is urgently needed. OBJECTIVE: Evaluate the diagnostic accuracy of serum cancer antigen 125 (CA 125) for endometriosis. SEARCH STRATEGY: We searched EMBASE, MEDLINE, and Web of Science from inception to January 2016. SELECTION CRITERIA: Diagnostic accuracy studies of serum CA 125 (index test) for histologically confirmed endometriosis (reference standard) were included. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials, extracted study characteristics and data. Methodological quality was assessed using Quality Assessment of Comparative Diagnostic Accuracy Studies (QUADAS-2) checklist. MAIN RESULTS: Twenty-two studies (16 cohort, six case-control), 3626 participants, were identified. Bivariate hierarchical models were used to pool accuracy data of 14 studies (2920 participants) using CA 125 ≥ 30 units/ml. Pooled specificity was 93% (95% CI 89-95%) and sensitivity 52% (95% CI 38-66%). CA 125 was significantly more sensitive for the diagnosis of moderate or severe endometriosis compared with minimal disease (63%, 95% CI 47-77% versus 24%, 95%CI 19-32%, P-value = 0.001). CONCLUSIONS:CA 125 performs well as a rule-in test facilitating expedited diagnosis and ensuring investigation and treatment can be confidently tailored for the management of endometriosis. Unfortunately, a negative test, CA 125 < 30 units/ml, is unable to rule out endometriosis. TWEETABLE ABSTRACT: Blood test CA 125: a rule-in test for the diagnosis of women presenting with symptoms of endometriosis.
Authors: Martin Widschwendter; Michal Zikan; Benjamin Wahl; Harri Lempiäinen; Tobias Paprotka; Iona Evans; Allison Jones; Shohreh Ghazali; Daniel Reisel; Johannes Eichner; Tamas Rujan; Zhen Yang; Andrew E Teschendorff; Andy Ryan; David Cibula; Usha Menon; Timo Wittenberger Journal: Genome Med Date: 2017-12-22 Impact factor: 11.117