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[一种新开发的用于肠炎患者的弯曲杆菌抗原检测试剂盒的评估]

[Evaluation of a Newly Developed Campylobacter Antigen Detection Kit for Patients with Enteritis].

作者信息

Tachikawa Natsuo, Yoshimura Yukihiro, Shimizu Tsunehiro, Tochitani Kentaro, Goto Tetsushi, Tsunoda Takahumi, Adachi Takuya, Kobayashi Kenichiro, Sakamoto Mitsuo, Onari Shigeru, Kawabata Naoki, Sakagami Yukiko, Sagara Hiroko

出版信息

Kansenshogaku Zasshi. 2017 Mar;91(2):145-50.

PMID:30277699
Abstract

The newly developed rapid diagnostic test (RDT, DK14-CA1, Denka Seiken Co., Ltd.) to detect Campylobacter antigen was evaluated using fecal specimens of patients with enteritis. The RDT is an immunochromatographic assay using colored latex and can detect Campylobacter antigen (C. jejuni and C. coli) from patients' stool samples within 15 minutes. A total of 227 stool samples obtained from patients with enteritis were examined and the results were compared with conventional culture methods. Overall sensitivity, specificity, accuracy and positive predictive value (PPV) were 75.6%, 98.6%, 89.9% and 97.0% respectively. Among 53 severe cases defined with their clinical findings, sensitivity, specificity, accuracy and PPV were 82.1%, 100%, 90.6% and 100% respectively. Mean time to obtain the result with the RDT was 7 minutes whereas the culture method took 2.2 days. This study revealed the usefulness of the newly developed RDT as a rapid detection tool for Campylobacter antigen. Although the RDT has a little lower sensitivity compared with culture method, the simple and rapid test can contribute to treatment decisions for patients with enteritis and can be used at the patient's bedside and in outpatient clinics.

摘要

使用肠炎患者的粪便标本对新开发的用于检测弯曲杆菌抗原的快速诊断测试(RDT,DK14-CA1,登卡精研株式会社)进行了评估。该RDT是一种使用彩色乳胶的免疫层析测定法,可在15分钟内从患者粪便样本中检测弯曲杆菌抗原(空肠弯曲菌和结肠弯曲菌)。共检查了227份从肠炎患者获得的粪便样本,并将结果与传统培养方法进行了比较。总体敏感性、特异性、准确性和阳性预测值(PPV)分别为75.6%、98.6%、89.9%和97.0%。在根据临床症状定义的53例重症病例中,敏感性、特异性、准确性和PPV分别为82.1%、100%、90.6%和100%。使用RDT获得结果的平均时间为7分钟,而培养方法需要2.2天。本研究揭示了新开发的RDT作为弯曲杆菌抗原快速检测工具的实用性。尽管RDT的敏感性与培养方法相比略低,但这种简单快速的测试可为肠炎患者的治疗决策提供帮助,并且可在患者床边和门诊诊所使用。

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[Evaluation of a Newly Developed Campylobacter Antigen Detection Kit for Patients with Enteritis].[一种新开发的用于肠炎患者的弯曲杆菌抗原检测试剂盒的评估]
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