Comparison of Clostridioides difficile Stool Toxin Concentrations in Adults With Symptomatic Infection and Asymptomatic Carriage Using an Ultrasensitive Quantitative Immunoassay
Comparison of Clostridioides difficile Stool Toxin Concentrations in Adults With Symptomatic Infection and Asymptomatic Carriage Using an Ultrasensitive Quantitative Immunoassay
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DOI：
10.1093/cid/ciy415
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发表时间：
2019-01-01
影响因子：
11.8
通讯作者：
Kelly, Ciaran P.
中科院分区：
文献类型：
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作者：
Pollock, Nira R.;Banz, Alice;Kelly, Ciaran P.
背景。采用超灵敏、定量单分子阵列（Simoa）免疫分析方法检测艰难梭菌感染（CDI）成人住院患者粪便中艰难梭菌毒素A和/或B的浓度是否高于无症状的艰难梭菌携带者。根据美国指南，加入CDI-NAAT的患者有临床显著的腹泻和核酸扩增试验（NAAT）阳性，并接受CDI治疗。潜在的携带者最近接受了抗生素治疗，没有腹泻；NAAT确认运货。基线粪便样本用Simoa检测毒素A和毒素b。CDI-NAAT组（n = 122）和携带者- naat组（n = 44）的粪便毒素浓度均为5 log （0 pg/mL至100 000 pg/mL）。122例CDI-NAAT中79例（65%）和44例携带者- naat中34例（77%）毒素A + B浓度>= 20 pg/mL（临床截止值）。毒素A、毒素B、毒素A + B和NAAT循环阈值中位数在CDI-NAAT和携带者-NAAT队列中相似（毒素A， 50.6 vs 60.0 pg/mL, P = 0.958；毒素B， 89.5 vs 42.3 pg/mL, P = 0.788；毒素A + B， 197.2 vs 137.3 pg/mL, P = 0.766; Ct, 28.1 vs 28.6, P = 0.354）。然而，当CDI/携带者队列仅限于毒素可检测者时，各自的中位数有显著差异（A: 874.0 vs 129.7, P = 0.021; B: 1317.0 vs 81.7, P = 0.003; A + B, 4180.7 vs 349.6, P = 0.004; Ct, 25.8 vs 27.7, P = 0.015）。毒素浓度不能区分CDI患者和无症状携带者。携带CDI组和携带CDI组的中位粪便毒素浓度存在差异，但仅当以可检测的粪便毒素（相对于NAAT阳性）来定义组时才存在差异。
Background. We used an ultrasensitive, quantitative single molecule array (Simoa) immunoassay to test whether concentrations of Clostridioides (formerly Clostridium) difficile toxins A and/or B in the stool of adult inpatients with C. difficile infection (CDI) were higher than in asymptomatic carriers of toxinogenic C. difficile.Methods. Patients enrolled as CDI-NAAT had clinically significant diarrhea and a positive nucleic acid amplification test (NAAT), per US guidelines, and received CDI treatment. Potential carriers had recently received antibiotics and did not have diarrhea; positive NAAT confirmed carriage. Baseline stool samples were tested by Simoa for toxin A and B.Results. Stool toxin concentrations in both CDI-NAAT (n = 122) and carrier-NAAT (n = 44) cohorts spanned 5 logs (0 pg/mL to >100 000 pg/mL). Seventy-nine of 122 (65%) CDI-NAAT and 34 of 44 (77%) carrier-NAAT had toxin A + B concentration >= 20 pg/mL (clinical cutoff). Median toxin A, toxin B, toxin A + B, and NAAT cycle threshold (Ct) values in CDI-NAAT and carrier-NAAT cohorts were similar (toxin A, 50.6 vs 60.0 pg/mL, P = .958; toxin B, 89.5 vs 42.3 pg/mL, P = .788; toxin A + B, 197.2 vs 137.3 pg/mL, P = .766; Ct, 28.1 vs 28.6, P = .354). However, when CDI/carrier cohorts were limited to those with detectable toxin, respective medians were significantly different (A: 874.0 vs 129.7, P = .021; B: 1317.0 vs 81.7, P = .003, A + B, 4180.7 vs 349.6, P = .004; Ct, 25.8 vs 27.7, P = .015).Conclusions. Toxin concentration did not differentiate an individual with CDI from one with asymptomatic carriage. Median stool toxin concentrations in groups with CDI vs carriage differed, but only when groups were defined by detectable stool toxin (vs positive NAAT).