艰难梭菌毒素检测试剂盒的诊断能力系统评价

David

                               
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Volume 8, Issue 12, December 2008, Pages 777-784

Review Diagnosis of Clostridium difficile infection by toxin detection kits: a systematic review
艰难梭菌毒素检测试剂盒的诊断能力系统评价

Tim Planche MDa, b, Adamma Aghaizu MScc, Richard Holliman MDa, b, Peter Riley MDa, b, Jan Poloniecki DPhilc, Aodhán Breathnach FRCPatha, b, d and Prof Sanjeev Krishna ScDb,

                               
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aDepartment of Medical Microbiology, St George's Hospital, London, UK
bCentre for Infection, Division of Cellular and Molecular Medicine, St George's University of London, London, UK
cDepartment of Community Health Sciences, St George's University of London, London, UK
dHealth Protection Agency Collaborating Centre, Department of Medical Microbiology, St George's Hospital, London, UK


Available online 1 November 2008.


SummaryClostridium difficile can be a fatal hospital-acquired infection and its prevalence has increased. Accurate diagnosis of C difficile is essential for patient management, infection control, and for defining its epidemiology. We did a systematic review of commonly used commercial assays for detection of C difficile toxin (CDT) A and B in stool samples. By comparison of detection of CDT in cell culture with or without selective culture for C difficile, the median sensitivities and specificities (IQR) were as follows: Meridian Premier 0·95 (0·86–0·97) and 0·97 (0·95–0·98), TechLab Tox A/B II 0·83 (0·82–0·85) and 0·99 (0·98–1·00), TechLab Tox A/B Quik Chek 0·84 (0·81–0·87) and 1·00 (0·99–1·00), Remel Xpect 0·82 (0·75–0·89) and 0·96 (0·95–0·98), Meridian Immunocard 0·90 (0·84–0·92) and 0·99 (0·98–1·00), and BioMérieux VIDAS 0·76 and 0·93. If the prevalence of CDT A and B in stool samples is relatively low (<10%), the positive predictive value of these assays is unacceptably low (eg, <50% in some circumstances) and will vary depending on the assay and number of samples tested. This low positive predictive value impinges on clinical management, outbreaks, and makes epidemiological data unreliable. To improve diagnosis, we suggest a two-stage testing strategy for C difficile toxin with an initial highly sensitive rapid screening test to identify positive samples that are then confirmed by a reference method.

Article OutlineIntroduction Methods Performance characteristics of tests Data source Study eligibility Data extraction and quality assessment Statistical analysisResults Discussion Search strategy and selection criteria References