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

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

doi:10.1002/jcla.22135

Cited by 14 publications

(9 citation statements)

References 35 publications

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“…These techniques were labor intensive with a long turnaround time, often limiting their use for routine testing. Quik Chek Complete EIA demonstrated low sensitivity (46.7%) and high specificity (100%), and is comparable to the findings from recent independent studies by Seo et al and Chung et al [26,27]. Studies by Sharp et al and Quin et al obtained a sensitivity range of 61–73% and a specificity range of 97.3–99.9%.…”

Section: Discussionsupporting

confidence: 85%

Effectiveness of a Two-Step Testing Algorithm for Reliable and Cost-Effective Detection of Clostridium difficile Infection in a Tertiary Care Hospital in Saudi Arabia

2019

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The aim of this study was to evaluate the effectiveness of a two-step algorithm for the detection of Clostridium difficile infection. Setting and Design: A two-step testing algorithm was evaluated for testing stool samples from patients suspected of Clostridium difficile infection (CDI). A total of 103 stool specimens were tested using the C. diff Quik Chek Complete enzyme immunoassay (EIA) test and the Xpert C. difficile PCR test. A two-step algorithm was implemented, and data from 3518 patient samples tested during a two-year period after implementation were analyzed to evaluate the effectiveness. The sensitivity, specificity, and positive and negative predictive values (PPV, NPV) of the Quik Chek Complete EIA test were calculated using the Xpert C. difficile PCR test as a reference method. The sensitivity, specificity, PPV, and NPV of the Quik Chek Complete EIA test for C. difficile toxin were 46.7%, 100%, 100%, and 91%, respectively. The two-step algorithm, which combined the Quik Chek Complete EIA with Xpert C. difficile PCR, improved the sensitivity and also provided rapid detection. When algorithm-based testing was performed daily, there was a 66% reduction in turnaround time compared to batch testing using a lengthy ELISA procedure. Postimplementation data analysis showed that almost 89% of the samples could be reported immediately by initial screening with Quik Chek Complete EIA. Only 11% of the samples gave discrepant results and required PCR confirmation. According to our results, the two-step algorithm is an effective tool for the rapid and reliable detection of toxigenic C. difficile from stool samples.

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Section: Discussionsupporting

confidence: 85%

Effectiveness of a Two-Step Testing Algorithm for Reliable and Cost-Effective Detection of Clostridium difficile Infection in a Tertiary Care Hospital in Saudi Arabia

2019

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“…In contrast to the high sensitivity of GDH detection, lateral flow tests for the identification of the A/B toxin showed a markedly low sensitivity (19.2 to 23.1%), also found for the results of the ELISA kit, corroborating previous studies [6,19,23]. The limitations are related to the detection of free A/B toxins, which are susceptible to degradation and, more importantly, maybe present at levels below the threshold of detection [12,24].…”

supporting

confidence: 83%

“…This rate had a mild influence on the specificity of both GDH tests in this study, which was kept above 92%. Although the rates of patients with nontoxigenic strains are generally similar to that seen in this study [5,19], there are reports of rates higher than 50% in some other institutions [18,[20][21][22]. Thus, it should be considered that the use of GDH as a single method should be preceded by an evaluation of its specificity and PPV in the institution, thus avoiding unnecessary antimicrobial treatment for CDI in asymptomatic carriers [9].…”

supporting

confidence: 75%

Evaluation of glutamate dehydrogenase (GDH) and toxin A/B rapid tests for Clostridioides (prev. Clostridium) difficile diagnosis in a university hospital in Minas Gerais, Brazil

et al. 2020

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Clostridioides (Clostridium) difficile is responsible for most cases of nosocomial diarrhea and, despite the high prevalence of the disease worldwide, the best laboratory diagnostic approach to diagnose C. difficile infection (CDI) is a subject of ongoing debate. Although the use of multiple tests is recommended, the cost of these algorithms commonly exceeds the affordability in some countries. Thus, to improve CDI diagnosis in a university hospital in Brazil, this study analyzed two immunochromatographic tests and one enzyme immunoassay (ELISA) to evaluate the detection of glutamate dehydrogenase (GDH) and A/B toxins of C. difficile. Stool samples of 89 adult patients presenting nosocomial diarrhea during hospitalization were included. The toxigenic culture was used as the reference method. GDH detection by both commercial tests showed high sensitivity (100%) and specificity (92.1%). On the other hand, toxin-based methods showed a sensitivity between 19.2 and 57.7%. In conclusion, the results suggest that rapid tests for GDH detection are not only suitable for CDI diagnosis as screening tests but also as a single method. Keywords Pseudomembranous colitis. Nosocomial diarrhea Clostridioides (Clostridium) difficile is responsible for most cases of antibiotic-associated diarrhea worldwide [1]. Despite the severity of the disease, the best laboratory diagnostic approach to diagnose C. difficile infection (CDI) is a subject of ongoing debate [2]. The diagnosis of CDI is frequently based on the clinical history and the detection of A/B toxins, and/or toxigenic isolates, by a combination of laborious methods [3]. In this context, the use of rapid tests for the detection of C. difficile glutamate dehydrogenase (GDH) is increasing as a screening method due to its low cost, high sensitivity, and fast results [4, 5]. However, if this method is not capable of differentiating non-toxigenic from toxigenic C. difficile strains, a stool sample positive for GDH is usually subjected to a second test involving a toxin-detecting assay, such as enzyme immunoassays (ELISA) and lateral flow tests, or a DNA-based test, commonly nucleic acid amplification-based tests [3]. Although the use of multiple tests is highly recommended to diagnose CDI [3], the cost of these algorithms commonly exceeds the affordability in developing countries [5]. In Brazil, despite the low sensitivity of ELISAs for the detection of A/B toxins, this method is still largely used as a single test in several hospitals [6, 7]. The use of a low sensitivity test can jeopardize the efficacy of control measures if infected individuals are kept without the necessary isolation and are not properly treated [6, 8]. Thus, to improve CDI diagnosis, this study aimed to evaluate two commercial assays for CDI diagnosis through detection of the GDH component and A/B toxins in hospitalized adults with diarrhea in a university hospital in Brazil.

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

Cited by 14 publications

References 35 publications

Effectiveness of a Two-Step Testing Algorithm for Reliable and Cost-Effective Detection of Clostridium difficile Infection in a Tertiary Care Hospital in Saudi Arabia

Effectiveness of a Two-Step Testing Algorithm for Reliable and Cost-Effective Detection of Clostridium difficile Infection in a Tertiary Care Hospital in Saudi Arabia

Evaluation of glutamate dehydrogenase (GDH) and toxin A/B rapid tests for Clostridioides (prev. Clostridium) difficile diagnosis in a university hospital in Minas Gerais, Brazil

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

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