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本文引用的文献

1
High Agreement Between an Ultrasensitive Clostridioides difficile Toxin Assay and a C. difficile Laboratory Algorithm Utilizing GDH-and-Toxin Enzyme Immunoassays and Cytotoxin Testing.高敏艰难梭菌毒素检测与应用谷氨酸脱氢酶和毒素酶联免疫吸附试验及细胞毒素检测的艰难梭菌实验室算法的高度一致性。
J Clin Microbiol. 2020 Jan 28;58(2). doi: 10.1128/JCM.01629-19.
2
Increased Clinical Specificity with Ultrasensitive Detection of Clostridioides difficile Toxins: Reduction of Overdiagnosis Compared to Nucleic Acid Amplification Tests.超敏检测艰难梭菌毒素可提高临床特异性：与核酸扩增检测相比，减少过度诊断。
J Clin Microbiol. 2019 Oct 23;57(11). doi: 10.1128/JCM.00945-19. Print 2019 Nov.
3
Ultrasensitive Detection of Clostridioides difficile Toxins in Stool by Use of Single-Molecule Counting Technology: Comparison with Detection of Free Toxin by Cell Culture Cytotoxicity Neutralization Assay.利用单分子计数技术检测粪便中的艰难梭菌毒素：与细胞培养细胞毒性中和试验检测游离毒素的比较。
J Clin Microbiol. 2019 Oct 23;57(11). doi: 10.1128/JCM.00719-19. Print 2019 Nov.
4
Toxin A-Predominant Pathogenic Clostridioides difficile: A Novel Clinical Phenotype.产毒为主的艰难梭菌：一种新的临床表型。
Clin Infect Dis. 2020 Jun 10;70(12):2628-2633. doi: 10.1093/cid/ciz727.
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The perils of PCR-based diagnosis of Clostridioides difficile infections: Painful lessons from clinical trials.基于 PCR 的艰难梭菌感染诊断的风险：临床试验的惨痛教训。
Anaerobe. 2019 Dec;60:102048. doi: 10.1016/j.anaerobe.2019.06.001. Epub 2019 Jun 12.
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Laboratory comparison between cell cytotoxicity neutralization assay and ultrasensitive single molecule counting technology for detection of Clostridioides difficile toxins A and B, PCR, enzyme immunoassays, and multistep algorithms.实验室比较细胞毒性中和测定法与超敏单分子计数技术，用于检测艰难梭菌毒素 A 和 B、PCR、酶免疫测定法和多步骤算法。
Diagn Microbiol Infect Dis. 2019 Sep;95(1):20-24. doi: 10.1016/j.diagmicrobio.2019.04.002. Epub 2019 Apr 9.
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Cross-sectional study of the prevalence, causes and management of hospital-onset diarrhoea.医院获得性腹泻的患病率、病因及处理的横断面研究。
J Hosp Infect. 2019 Oct;103(2):200-209. doi: 10.1016/j.jhin.2019.05.001. Epub 2019 May 8.
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Advances in Diagnostic Testing that Impact Infection Prevention and Antimicrobial Stewardship Programs.影响感染预防和抗菌药物管理计划的诊断检测进展。
Curr Infect Dis Rep. 2019 May 1;21(6):20. doi: 10.1007/s11908-019-0676-7.
9
Ultrasensitive Detection of Clostridium difficile Toxins Reveals Suboptimal Accuracy of Toxin Gene Cycle Thresholds for Toxin Predictions.超敏检测艰难梭菌毒素揭示毒素基因循环阈值对毒素预测的准确性欠佳。
J Clin Microbiol. 2019 May 24;57(6). doi: 10.1128/JCM.01885-18. Print 2019 Jun.
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Global burden of infections: a systematic review and meta-analysis.全球 感染负担：系统评价和荟萃分析。
J Glob Health. 2019 Jun;9(1):010407. doi: 10.7189/jogh.09.010407.

用于提高诊断准确性的超敏艰难梭菌毒素检测

Ultrasensitive Clostridioides difficile Toxin Testing for Higher Diagnostic Accuracy.

作者信息

Sandlund Johanna, Davies Kerrie, Wilcox Mark H

机构信息

Fluxus, Inc., Santa Clara, California, USA.

Healthcare Associated Infections Research Group, Leeds Teaching Hospitals NHS Trust and University of Leeds, Leeds, United Kingdom.

出版信息

J Clin Microbiol. 2020 May 26;58(6). doi: 10.1128/JCM.01913-19.

DOI:10.1128/JCM.01913-19
PMID:32269098
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7269404/
Abstract

Currently available diagnostic tests for infection (CDI) lack specificity or sensitivity, which has led to guideline recommendations for multistep testing algorithms. Ultrasensitive assays for detection of toxins provide measurements of disease-specific markers at very low concentrations. These assays may show improved accuracy compared to that of current testing methods and offer a potential standalone solution for CDI diagnosis, although large studies of clinical performance and accuracy are lacking.

摘要

目前可用的艰难梭菌感染（CDI）诊断测试缺乏特异性或敏感性，这导致了对多步骤测试算法的指南建议。用于检测毒素的超灵敏测定法能够在非常低的浓度下测量疾病特异性标志物。与当前的测试方法相比，这些测定法可能显示出更高的准确性，并为CDI诊断提供了一种潜在的独立解决方案，尽管缺乏关于临床性能和准确性的大型研究。