中国感染控制杂志2025，Vol.24Issue(4)：451-459,9.DOI:10.12138/j.issn.1671-9638.20255458
基于艰难梭菌tcdC基因的新型LAMP检测方法的研发及临床诊断效能评估
Development and clinical diagnostic efficacy of a novel LAMP method tar-geting the tcdC gene in Clostridioides difficile
摘要
Abstract
Objective To develop a method for rapidly identifying Clostridioides difficile(C.difficile)and de-termining high-producing toxin strains,conduct clinical evaluation.Methods The loop-mediated isothermal amplifi-cation(LAMP)method was used to identify C.difficile based on the tcdC,tcdA,and tcdB genes.The sensitivi-ty,specificity,and overall consistency of the detection method were evaluated.Results Feces specimens from 499 hospitalized patients suspected of C.difficile-associated diarrhea were detected,with C.difficile detection rate of 12.8％(64/499),out of which the detection rate of toxin-producing C.difficile was 10.8％(54/499).The sensi-tivity,specificity,positive predictive value,and negative predictive value of the detection method for tcdA were 87.2％,98.9％,89.1％,and 98.6％,respectively,and 88.2％,99.6％,90.0％,and 98.73％for tcdB,respec-tively.The total toxin levels of different strains were different,but the average toxin production level of A+B+strains(1.79 μg/mL)was higher than those of A-B+strains(0.72 μg/mL)and A-B-strains(＜0.10 μg/mL).Conclusion The portable high-throughput LAMP detection method can rapidly and efficiently identify C.difficile and determine high-producing toxin strains.关键词
艰难梭菌/艰难梭菌感染/分子诊断/毒素基因/毒力调节基因/tcdCKey words
Clostridioides difficile/Clostridioides difficile infection/molecular diagnosis/toxin gene/viru-lence regulatory gene/tcdC分类
医药卫生引用本文复制引用
肖园园,段菊屏,周景翔,黄琴,卿琰,王海波,吴安华,李春辉..基于艰难梭菌tcdC基因的新型LAMP检测方法的研发及临床诊断效能评估[J].中国感染控制杂志,2025,24(4):451-459,9.基金项目
国家重点研发计划项目(2022YFC2009801、2022YFC2009805) （2022YFC2009801、2022YFC2009805）
湖南省重点研发计划项目(2020SK3028) （2020SK3028）
长沙市科技计划项目(kq2202059) （kq2202059）
中南大学湘雅医院科技成果转化基金项目(2024ZHJJ06) （2024ZHJJ06）
