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Multicenter Evaluation of Clinical Diagnostic Methods for Detection and Isolation of Campylobacter spp. from Stool

机译:检测和分离弯曲杆菌属的临床诊断方法的多中心评估。从凳子

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The use of culture-independent diagnostic tests (CIDTs), such as stool antigen tests, as standalone tests for the detection of Campylobacter in stool is increasing. We conducted a prospective, multicenter study to evaluate the performance of stool antigen CIDTs compared to culture and PCR for Campylobacter detection. Between July and October 2010, we tested 2,767 stool specimens from patients with gastrointestinal illness with the following methods: four types of Campylobacter selective media, four commercial stool antigen assays, and a commercial PCR assay. Illnesses from which specimens were positive by one or more culture media or at least one CIDT and PCR were designated “cases.” A total of 95 specimens (3.4%) met the case definition. The stool antigen CIDTs ranged from 79.6% to 87.6% in sensitivity, 95.9 to 99.5% in specificity, and 41.3 to 84.3% in positive predictive value. Culture alone detected 80/89 (89.9% sensitivity) Campylobacter jejuni/Campylobacter coli-positive cases. Of the 209 noncases that were positive by at least one CIDT, only one (0.48%) was positive by all four stool antigen tests, and 73% were positive by just one stool antigen test. The questionable relevance of unconfirmed positive stool antigen CIDT results was supported by the finding that noncases were less likely than cases to have gastrointestinal symptoms. Thus, while the tests were convenient to use, the sensitivity, specificity, and positive predictive value of Campylobacter stool antigen tests were highly variable. Given the relatively low incidence of Campylobacter disease and the generally poor diagnostic test characteristics, this study calls into question the use of commercially available stool antigen CIDTs as standalone tests for direct detection of Campylobacter in stool.
机译:越来越多地使用独立于粪便中弯曲杆菌的独立于粪便抗原测试的培养独立诊断测试(CIDT)。我们进行了一项前瞻性,多中心研究,以评估粪便抗原CIDT与培养液和PCR检测弯曲杆菌的性能。在2010年7月至2010年10月之间,我们使用以下方法测试了来自胃肠道疾病患者的2767份粪便标本:四种类型的弯曲杆菌选择性培养基,四种商业粪便抗原测定法和一种商业PCR测定法。样本被一种或多种培养基或至少一种CIDT和PCR呈阳性的疾病称为“病例”。共有95个样本(3.4%)符合病例定义。粪便抗原CIDT的敏感性范围为79.6%至87.6%,特异性为95.9至99.5%,阳性预测值为41.3至84.3%。单独培养可检测到80/89(灵敏度为89.9%)空肠弯曲菌/大肠杆菌弯曲杆菌阳性病例。在至少一项CIDT呈阳性的209个非病例中,在全部四个粪便抗原检测中只有一个(0.48%)阳性,而仅一项粪便抗原检测为73%。粪便抗原CIDT阳性结果未经证实的相关性值得怀疑,这一发现支持以下发现:非病例比胃肠道症状的可能性小。因此,尽管这些测试使用方便,但弯曲杆菌粪便抗原测试的敏感性,特异性和阳性预测值变化很大。鉴于弯曲菌病的发病率相对较低,并且诊断测试特性普遍较差,这项研究使人们怀疑将市售粪便抗原CIDT用作直接检测粪便中弯曲菌的独立测试方法。

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