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艰难梭菌感染的实验室诊断:Techlab艰难梭菌快速检测全套、Xpert艰难梭菌检测与多步骤算法方法的比较

Laboratory diagnosis of Clostridium difficile infection: Comparison of Techlab C. diff Quik Chek Complete, Xpert C. difficile, and multistep algorithmic approach.

作者信息

Seo Ja Young, Jeong Ji Hun, Kim Kyung Hee, Ahn Jeong-Yeal, Park Pil-Whan, Seo Yiel-Hea

机构信息

Department of Laboratory Medicine, Gachon University Gil Medical Center, Incheon, Korea.

出版信息

J Clin Lab Anal. 2017 Nov;31(6). doi: 10.1002/jcla.22135. Epub 2017 Feb 8.

Abstract

BACKGROUND

Clostridium difficile is a major pathogen responsible for nosocomial infectious diarrhea. We explored optimal laboratory strategies for diagnosis of C. difficile infection (CDI) in our clinical settings, a 1400-bed tertiary care hospital.

METHODS

Using 191 fresh stool samples from adult patients, we evaluated the performance of Xpert C. difficile (Xpert CD), C. diff Quik Chek Complete (which simultaneously detects glutamate dehydrogenase [GDH] and C. difficile toxins [CDT]), toxigenic culture, and a two-step algorithm composed of GDH/CDT as a screening test and Xpert CD as a confirmatory test.

RESULTS

Clostridium difficile was detected in 35 samples (18.3%), and all isolates were toxigenic strains. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value of each assay for detecting CDI were as follows: Quik Chek Complete CDT (45.7%, 100%, 100%, 89.1%), Quik Chek Complete GDH (97.1%, 99.4%, 97.1%, 99.4%), Xpert CD (94.3%, 100%, 100%, 98.7%), and toxigenic culture (91.4%, 100%, 100%, 98.1%). A two-step algorithm performed identically with Xpert CD assay.

CONCLUSION

Our data showed that most C. difficile isolates from adult patients were toxigenic. We demonstrated that a two-step algorithm based on GDH/CDT assay followed by Xpert CD assay as a confirmatory test was rapid, reliable, and cost effective for diagnosis of CDI in an adult patient setting with high prevalence of toxigenic C. difficile.

摘要

背景

艰难梭菌是引起医院感染性腹泻的主要病原体。我们在一家拥有1400张床位的三级护理医院的临床环境中探索了诊断艰难梭菌感染(CDI)的最佳实验室策略。

方法

我们使用来自成年患者的191份新鲜粪便样本,评估了Xpert艰难梭菌检测(Xpert CD)、艰难梭菌快速检测试剂盒(同时检测谷氨酸脱氢酶[GDH]和艰难梭菌毒素[CDT])、产毒培养以及由GDH/CDT作为筛查试验和Xpert CD作为确认试验组成的两步算法的性能。

结果

在35份样本(18.3%)中检测到艰难梭菌,所有分离株均为产毒菌株。检测CDI的各项检测方法的灵敏度、特异性、阳性预测值(PPV)和阴性预测值(NPV)如下:快速检测试剂盒CDT(45.7%,100%,100%,89.1%),快速检测试剂盒GDH(97.1%,99.4%,97.1%,99.4%),Xpert CD(94.3%,100%,100%,98.7%),以及产毒培养(91.4%,100%,100%,98.1%)。两步算法与Xpert CD检测法表现相同。

结论

我们的数据表明,成年患者中分离出的大多数艰难梭菌菌株是产毒的。我们证明,在产毒艰难梭菌患病率高的成年患者中,基于GDH/CDT检测法随后以Xpert CD检测法作为确认试验的两步算法对于CDI的诊断快速、可靠且具有成本效益。

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