A Rapid, Accurate, Single Molecule Counting Method Detects Clostridium difficile Toxin B in Stool Samples.
A Rapid, Accurate, Single Molecule Counting Method Detects Clostridium difficile Toxin B in Stool Samples.
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DOI：
10.1038/s41598-018-26353-0
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发表时间：
2018-05-30
影响因子：
4.6
通讯作者：
Straus D
中科院分区：
文献类型：
--
作者：
Gite S;Archambault D;Cappillino MP;Cunha D;Dorich V;Shatova T;Tempesta A;Walsh B;Walsh JA;Williams A;Kirby JE;Bowers J;Straus D
我们描述了一种新的快速和准确的免疫测定为基础的技术，能够计数单个目标分子使用数字成像，而无需放大。利用这项技术，我们开发了一种快速检测艰难梭菌毒素B的方法，这种毒素是潜在致命的C。艰难梭菌感染（CDI）。目前还没有快速、敏感和特异的CDI检测方法。多路径C.艰难梭菌毒素B测试成像和计数目标特异性磁性和荧光颗粒的复合物，所述目标特异性磁性和荧光颗粒在最低限度处理的粪便样品中被毒素B分子束缚在一起。30分钟检测的性能特征包括4 - 5 pg/mL的检测限、覆盖4-5个数量级的动态范围和小于10%的变异系数。MultiPath检测可检出所有检测的毒素型和核糖体型，包括美国和欧盟最常见的毒素型和核糖体型;与相关菌种无交叉反应性;对粪便样本中常见的潜在干扰物具有稳健性。在320个临床粪便样本的训练集上，MultiPath C.与细胞毒性中和试验（CCNA）参考方法相比，艰难梭菌毒素B试验显示97.0%灵敏度（95% CI，91.4-99.4%）、98.3%特异性（95% CI，96.8-99.2%）和98.2%准确性（95% CI，96.7-99.0%）。基于这些令人信服的性能特点，我们相信多路径技术可以解决缺乏快速，灵敏，特异性和易于使用的诊断测试C。很难
We describe a new rapid and accurate immunoassay-based technology capable of counting single target molecules using digital imaging without magnification. Using the technology, we developed a rapid test for Clostridium difficile toxin B, which is responsible for the pathology underlying potentially fatal C. difficile infections (CDI). There are currently no tests for CDI that are rapid, sensitive, and specific. The MultiPath C. difficile toxin B test images and counts complexes of target-specific magnetic and fluorescent particles that have been tethered together by toxin B molecules in minimally processed stool samples. The performance characteristics of the 30 minute test include a limit of detection of 45 pg/mL, dynamic range covering 4–5 orders of magnitude, and coefficient of variation of less than 10%. The MultiPath test detected all toxinotypes and ribotypes tested, including the one most commonly occurring in the US and EU; shows no cross reactivity with relevant bacterial species; and is robust to potential interferants commonly present in stool samples. On a training set of 320 clinical stool samples, the MultiPath C. difficile toxin B test showed 97.0% sensitivity (95% CI, 91.4–99.4%); 98.3% specificity (95% CI, 96.8–99.2%); and 98.2% accuracy (95% CI, 96.7–99.0%) compared to the cellular cytotoxicity neutralization assay (CCNA) reference method. Based on these compelling performance characteristics, we believe the MultiPath technology can address the lack of rapid, sensitive, specific, and easy-to-use diagnostic tests for C. difficile.
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影响因子：
11.8
作者：
McDonald, L. Clifford;Gerding, Dale N.;Wilcox, Mark H.
通讯作者：
Wilcox, Mark H.
影响因子：
9.4
作者：
Pollock, Nira R.;Song, Linan;Kelly, Ciaran P.
通讯作者：
Kelly, Ciaran P.
影响因子：
9.4
作者：
Ryder, Alex B.;Huang, Ying;Tang, Yi-Wei
通讯作者：
Tang, Yi-Wei
影响因子：
64.8
作者：
Tao L;Zhang J;Meraner P;Tovaglieri A;Wu X;Gerhard R;Zhang X;Stallcup WB;Miao J;He X;Hurdle JG;Breault DT;Brass AL;Dong M
通讯作者：
Dong M
影响因子：
64.8
作者：
Lyras, Dena;O'Connor, Jennifer R.;Howarth, Pauline M.;Sambol, Susan P.;Carter, Glen P.;Phumoonna, Tongted;Poon, Rachael;Adams, Vicki;Vedantam, Gayatri;Johnson, Stuart;Gerding, Dale N.;Rood, Julian I.
通讯作者：
Rood, Julian I.