A 2-step algorithm combining glutamate dehydrogenase and nucleic acid amplification tests for the detection of Clostridi
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ORIGINAL ARTICLE
A 2-step algorithm combining glutamate dehydrogenase and nucleic acid amplification tests for the detection of Clostridioides difficile in stool specimens Chengcheng Liu 1 & Chenjie Tang 2 & Yaping Han 1 & Yuqiao Xu 1 & Fang Ni 1 & Ke Jin 3 & Genyan Liu 1 Received: 22 June 2020 / Accepted: 26 August 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract The optimized diagnosis algorithm of Clostridioides difficile infection (CDI) is worldwide concerns. The purpose of this study was to assess the toxigenic C. difficile test performance and propose an optimal laboratory workflow for the diagnosis of CDI in mild virulent epidemic areas. Diarrhea samples collected from patients were analyzed by glutamate dehydrogenase (GDH), toxin AB (CDAB), and nucleic acid amplification test (NAAT). We assessed the performance of GDH, the GDH-CDAB algorithm, and the GDH-NAAT algorithm using toxigenic culture (TC) as a reference method. In this study, 186 diarrhea samples were collected. The numbers of TC-positive and TC-negative samples were 39 and 147, respectively. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa of the GDH assay were 100%, 80.3%, 57.4%, 100%, and 0.63; of the GDH-CDAB algorithm were 48.7%, 97.3%, 82.6%, 87.7%, and 0.54; and of the GDH-NAAT algorithm were 74.4%, 100%, 100%, 93.6%, and 0.82, respectively. The GDH-NAAT algorithm has great concordance with TC in detecting toxigenic C. difficile (kappa = 0.82), while the sensitivity of the GDH-CDAB algorithm was too low to meet the demand of CDI diagnosis clinically. GDH-NAAT algorithm is recommended for the detection of toxigenic C. difficile with high specificity, increased sensitivity, and cost-effective. Keywords Clostridioides difficile . Glutamate dehydrogenase . Toxin genes amplification . Diagnosis
Introduction Clostridioides difficile infection (CDI) remains a considerable challenge to healthcare systems worldwide. The clinical symptoms of CDI vary from asymptomatic colonization, mild to severe diarrhea, toxic megacolon, bowel perforation, sepsis, Chengcheng Liu and Chenjie Tang contributed equally to this work. * Genyan Liu [email protected] 1
Department of Laboratory Medicine, National Key Clinical Department of Laboratory Medicine, The First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, People’s Republic of China
2
Department of Laboratory Medicine, Wuxi Children’s Hospital, The Affiliated Wuxi Children’s Hospital of Nanjing Medical University, Wuxi 214000, People’s Republic of China
3
Department of Infection Diseases, The First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, People’s Republic of China
shock, and even death [1]. Furthermore, CDI is the major cause of antibiotic-associated diarrhea (AAD), nosocomial infectious diarrhea, and pseudomembranous colitis [2, 3]. Since the 2000s, there has been a significant increase in the prevalence and severity of CDI in North America and Europe, with the most sev
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