Comparison of vidas Clostridium difficile toxin-A assay and premier C. difficile toxin-A assay to Cytotoxin-B tissue culture assay for the detection of toxins of C. difficile

Knapp, C C; Sandin, Ramón L.; Hall, Gerri S.; Ludwig, Margaret D.; Rutherford, Isobel; Washington, John A.

doi:10.1016/0732-8893(93)90062-c

Cited by 14 publications

(8 citation statements)

References 11 publications

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“…Of the 71 potentially relevant papers retrieved for more detailed assessment, 28 were excluded from further analysis: 15 studies investigated tests that were no longer commercially available; three studies did not test all samples with the reference test; three studies used an inappropriate reference standard; two studies comprised non‐clinical human stool samples; two studies did not report sufficient information to allow us to calculate sensitivity and specificity; one study using CCA did not report if neutralization of the cytopathic effect was executed; and for two studies, full text articles were not available. Therefore, a total of 43 studies was included in this systematic review [6–10,12–15,21–23,23–54].…”

Section: Resultsmentioning

confidence: 99%

European Society of Clinical Microbiology and Infectious Diseases (ESCMID): Data review and recommendations for diagnosing Clostridium difficile-infection (CDI)

Crobach

Dekkers

Wilcox

et al. 2009

Clinical Microbiology and Infection

366

298

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The aim of the present systematic review was to evaluate the available evidence on laboratory diagnosis of CDI and to formulate recommendations to optimize CDI testing. In comparison with cell culture cytotoxicity assay (CCA) and toxigenic culture (TC) of stools, we analyzed the test characteristics of 13 commercial available enzyme immunoasssays (EIA) detecting toxins A and/or B, 4 EIAs detecting Clostridium difficile glutamate dehydrogenase (GDH), and a real-time PCR for C. difficile toxin B gene. In comparison with CCA and TCA and assuming a prevalence of CDI of 5%, PPV and NPV varied between 0.28-0.77, 0.12-0.65 and 0.98-1.00, 0.97-1.00, respectively. Only if the tests were performed in a population with a CDI prevalence of 50 percent, would PPVs be acceptable (ranging from 0.71 to 1.00).To overcome the problem of a low PPV, we propose a two step approach, with a second test or a reference method in case of a positive first test. Further reducing the number of false negative results would require either retesting of all subjects with a negative first test, or re-testing all subjects with a negative second test, after an initially positive test. This approach resulted in non-significant improvements, and emphasizes the need for better diagnostic tests. Further studies to validate the applicability of two-step testing, including assessment of clinical features, are required.

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Section: Resultsmentioning

confidence: 99%

European Society of Clinical Microbiology and Infectious Diseases (ESCMID): Data review and recommendations for diagnosing Clostridium difficile-infection (CDI)

Crobach

Dekkers

Wilcox

et al. 2009

Clinical Microbiology and Infection

366

298

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“…One commonly used diagnostic assay is the C. difficile cytotoxin enzyme immunoassay. 18 This test is rapid and relatively easy to perform, but may have a greater than 10% false negative rate on initial testing. 18 Concern over C. difficile and its possible consequences may lead clinicians to institute empiric therapy despite a negative toxin assay.…”

Section: Discussionmentioning

confidence: 99%

“…18 This test is rapid and relatively easy to perform, but may have a greater than 10% false negative rate on initial testing. 18 Concern over C. difficile and its possible consequences may lead clinicians to institute empiric therapy despite a negative toxin assay. Sigmoidoscopy to detect the presence of characteristic pseudomembranes, although useful in some groups of patients, is potentially hazardous in the neutropenic patient.…”

Section: Discussionmentioning

confidence: 99%

High prevalence of diarrhea but infrequency of documented Clostridium difficile in autologous peripheral blood progenitor cell transplant recipients

Avery

Pohlman

Adal

et al. 2000

Bone Marrow Transplant

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Summary:Autologous peripheral blood progenitor cell (PBPC) transplant recipients frequently receive multiple antibiotics for neutropenic fever in addition to high-dose chemotherapy. Although there are many possible causes for diarrhea in this population, empiric therapy for possible C. difficile colitis is common in some centers. Diarrhea is a major cause of morbidity during high-dose chemotherapy followed by autologous peripheral blood progenitor cell (PBPC) transplant. Diarrhea in this setting is often persistent, profuse, and incompletely responsive to symptomatic management. It is generally attributed to the gastrointestinal mucosal effects of high-dose chemotherapy,

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“…The negative and positive predictive values have been shown to range from 97 to 99.7 and 85.7 to 94% respectively (244,289). Although detection of C. difficile toxin by the VIDAS CDA enzyme immunoassay requires an expensive microplate reader, the system compares favorably with the cellular cytotoxicity assay and turnaround time was decreased (147,244). In a study of 194 clinical specimens, Shanholtzer et al (245) indicated that the usefulness of the VIDAS CDA enzyme immunoassay was diminished by a high percentage (19%) of results that could not be interpreted.…”

Section: Enzyme-linked Assay Systemsmentioning

confidence: 99%

“…enzyme immunoassay was evaluated (46,147,244,289). For 88 specimens, the assay showed a sensitivity, specificity, and correlation of 92.3, 100, and 96.6%, respectively, when compared with the cellular cytotoxicity assay (46).…”

Section: Enzyme-linked Assay Systemsmentioning

confidence: 99%

Clostridium difficile: clinical disease and diagnosis

1993

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Clostridium difficile is an opportunistic pathogen that causes a spectrum of disease ranging from antibiotic-associated diarrhea to pseudomembranous colitis. Although the disease was first described in 1893, the etiologic agent was not isolated and identified until 1978. Since clinical and pathological features of C. difficile-associated disease are not easily distinguished from those of other gastrointestinal diseases, including ulcerative colitis, chronic inflammatory bowel disease, and Crohn's disease, diagnostic methods have relied on either isolation and identification of the microorganism or direct detection of bacterial antigens or toxins in stool specimens. The current review focuses on the sensitivity, specificity, and practical use of several diagnostic tests, including methods for culture of the etiologic agent, cellular cytotoxicity assays, latex agglutination tests, enzyme immunoassay systems, counterimmunoelectrophoresis, fluorescent-antibody assays, and polymerase chain reactions.

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Comparison of vidas Clostridium difficile toxin-A assay and premier C. difficile toxin-A assay to Cytotoxin-B tissue culture assay for the detection of toxins of C. difficile

Cited by 14 publications

References 11 publications

European Society of Clinical Microbiology and Infectious Diseases (ESCMID): Data review and recommendations for diagnosing Clostridium difficile-infection (CDI)

European Society of Clinical Microbiology and Infectious Diseases (ESCMID): Data review and recommendations for diagnosing Clostridium difficile-infection (CDI)

High prevalence of diarrhea but infrequency of documented Clostridium difficile in autologous peripheral blood progenitor cell transplant recipients

Clostridium difficile: clinical disease and diagnosis

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