A prospective study of two isothermal amplification assays compared with real-time PCR, CCNA and toxigenic culture for the diagnosis of Clostridium difficile infection

Neuendorf, Martina; Guadarrama-Gonzalez, Raquel; Lamik, Birgit; MacKenzie, Colin R.

doi:10.1186/s12866-016-0635-5

Cited by 8 publications

(9 citation statements)

References 28 publications

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“…After excluding seven Korean studies from the 31 international ones, we assessed a total of 39 studies (24 foreign and 15 Korean) ( Table 2 ). The details of each study are summarized in Supplemental Data Table S1 [ 6 - 44 ].…”

Section: Methodsmentioning

confidence: 99%

Laboratory Diagnostic Methods for Clostridioides difficile Infection: the First Systematic Review and Meta-analysis in Korea

2021

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Background Various methods are used for the diagnosis of Clostridioides difficile infection (CDI). We systematically analyzed and investigated the performance of current laboratory diagnostic methods for CDI. Methods We performed systematic review and meta-analysis of studies in PubMed, Web of Science, Cochrane Library, and KoreaMed. The following methods were evaluated glutamate dehydrogenase (GDH) enzyme immunoassays (GDH EIAs), toxin A and B detection by enzyme immunoassays (toxin AB EIAs), and nucleic acid amplification tests (NAATs) for C. difficile toxin genes. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of each method were calculated. Results Based on 39 studies, the pooled sensitivities/specificities were 92.7%/94.6%, 57.9%/97.0%, and 90.0%/95.8% for GDH EIAs, toxin AB EIAs, and NAATs, respectively, compared with those of toxigenic culture. The pooled sensitivities of automated EIAs were significantly higher than those of non-automated EIAs for both GDH and toxins A and B. The pooled sensitivity of Xpert C. difficile was significantly higher than those of other NAATs. PPVs increased as CDI prevalence increased, and NPVs were excellent when CDI prevalence was low; at CDI prevalence of 5%, PPV = 37%-65% and NPV = 97%-100%; at CDI prevalence of 50%, PPV = 92%-97% and NPV = 65%-98%. Conclusions Toxin AB EIAs still show unsatisfactory sensitivity, whereas GDH EIAs and NAATs show relatively high sensitivity. However, toxin AB EIAs are the most specific tests. This study may provide useful information for CDI diagnosis.

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Section: Methodsmentioning

confidence: 99%

Laboratory Diagnostic Methods for Clostridioides difficile Infection: the First Systematic Review and Meta-analysis in Korea

2021

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“…While the prevalence of RT027 was generally low in regional/local studies between 2007 and 2010 (mean = 3.3%), it increased markedly to a mean value of 21.3% in the following years until 2017. Between 2011 and 2017 the prevalence of RT027 ranged between a minimum of 10.3% in Lower Saxony [ 34 ] and a maximum of 37.4% in Düsseldorf [ 35 ]. A relatively high prevalence was reported mainly from south-west and central Germany, the highest rate being 37.4% reported from Düsseldorf in the State of North Rhine-Westphalia.…”

Section: Resultsmentioning

confidence: 99%

The largely unnoticed spread of Clostridioides difficile PCR ribotype 027 in Germany after 2010

Marujo

Arvand

2020

Infection Prevention in Practice

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Summary In recent decades, incidence and severity of Clostridioides difficile infection (CDI) has increased dramatically, coinciding with the emergence of hypervirulent strains such as PCR ribotype 027 (RT027). Data on prevalence of distinct C. difficile strains in random CDI cases in Germany are scarce. The aim of this review was to obtain an overview of prevalence and geographical distribution of RT027 among clinical C. difficile isolates from random cases in non-outbreak settings in hospitals in Germany. For this purpose, we performed a literature review on reported cases of C. difficile RT027 in Germany between 2007 and 2019 in three databases (PubMed, Embase and LIVIVO) and conference proceedings. Studies with selection bias for RT027 (e.g. clinical severity, outbreak reports) were excluded. A total of 304 records were screened, from which 21 were included in this analysis. The nationwide prevalence of RT027 in Germany was <1% prior to 2010 but increased continuously thereafter, reaching 21.7% in 2013. The regional prevalence varied markedly between federal states, higher prevalence was reported from North Rhine-Westphalia (37.4%) and Saxony (31.8%) in 2013-2015. However, data on C. difficile RT027 were not available from almost half of the federal states and were scarce at the national level. Our data suggest a remarkable spread of RT027 in Germany during the past decade, which has remained rather unnoticed so far. A national program for molecular surveillance of C. difficile is required to monitor the changing epidemiology of CDI and to adjust the prevention and control measures.

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“…The AmpliVue assay had a sensitivity of 96% and specificity of 100% when compared to the FDA-cleared assay Meridian Illumigene Assay[ 99 ]. Compared to TC, the sensitivity and specificity were 91% and 89%, respectively[ 100 ].…”

Section: Diagnostic Testsmentioning

confidence: 99%

Current knowledge on the laboratory diagnosis ofClostridium difficileinfection

Martínez-Meléndez¹,

Camacho-Ortíz²,

Morfín‐Otero³

et al. 2017

WJG

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Clostridium difficile (C. difficile) is a spore-forming, toxin-producing, gram-positive anaerobic bacterium that is the principal etiologic agent of antibiotic-associated diarrhea. Infection with C. difficile (CDI) is characterized by diarrhea in clinical syndromes that vary from self-limited to mild or severe. Since its initial recognition as the causative agent of pseudomembranous colitis, C. difficile has spread around the world. CDI is one of the most common healthcare-associated infections and a significant cause of morbidity and mortality among older adult hospitalized patients. Due to extensive antibiotic usage, the number of CDIs has increased. Diagnosis of CDI is often difficult and has a substantial impact on the management of patients with the disease, mainly with regards to antibiotic management. The diagnosis of CDI is primarily based on the clinical signs and symptoms and is only confirmed by laboratory testing. Despite the high burden of CDI and the increasing interest in the disease, episodes of CDI are often misdiagnosed. The reasons for misdiagnosis are the lack of clinical suspicion or the use of inappropriate tests. The proper diagnosis of CDI reduces transmission, prevents inadequate or unnecessary treatments, and assures best antibiotic treatment. We review the options for the laboratory diagnosis of CDI within the settings of the most accepted guidelines for CDI diagnosis, treatment, and prevention of CDI.

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A prospective study of two isothermal amplification assays compared with real-time PCR, CCNA and toxigenic culture for the diagnosis of Clostridium difficile infection

Cited by 8 publications

References 28 publications

Laboratory Diagnostic Methods for Clostridioides difficile Infection: the First Systematic Review and Meta-analysis in Korea

Laboratory Diagnostic Methods for Clostridioides difficile Infection: the First Systematic Review and Meta-analysis in Korea

The largely unnoticed spread of Clostridioides difficile PCR ribotype 027 in Germany after 2010

Current knowledge on the laboratory diagnosis ofClostridium difficileinfection

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