What question did this study set out to answer?

To evaluate the diagnostic performance of two rapid toxin A detection assays against standard cytotoxin testing and toxigenic culture for identifying Clostridium difficile-associated diarrhea.

September 1, 1999Journal of Clinical MicrobiologyOpen Access

Evaluation of Two Rapid Assays for Detection of Clostridium difficile Toxin A in Stool Specimens

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Authors

DFDaniel P. FedorkoCenter for Devices and Radiological Health HEHoward D. EnglerLabCorp (United States)EOElizabeth O’ShaughnessyNational Institutes of Health

Discussion

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Implication

Diagnostic comparative study reveals low sensitivity of rapid toxin A assays for Clostridium difficile diarrhea, indicating they are insufficient alone for accurate clinical detection.

Key Points

To evaluate the diagnostic performance of two rapid toxin A detection assays against standard cytotoxin testing and toxigenic culture for identifying Clostridium difficile-associated diarrhea.
Tested 654 stool specimens using two rapid assays (Immunocard Toxin A and Culturette Brand Toxin CD enzyme immunoassay), a cytotoxin assay, and toxigenic culture on cycloserine-cefoxitin-fructose agar.
Conducted patient chart reviews for discordant specimens positive on one to three assays to define a composite reference standard alongside specimens positive on all four tests.
Overall agreement across all four testing modalities was 90.5% (592 of 654 specimens), with 97 specimens (14.8%) positive by one or more tests.
Toxigenic culture achieved a sensitivity of 94.7%, specificity of 98.6%, PPV of 87.1%, and NPV of 99.5%, while the cytotoxin assay achieved 87.7%, 98.6%, 86.2%, and 98.8%, respectively.
The rapid Immunocard and Culturette EIA demonstrated high specificities (99.3% and 99.1%) but poor sensitivities (71.9% and 68.4%, respectively).

Cite This Study

Fedorko et al. (1999) studied this question.

synapsesocial.com/papers/6a86aa257fdf9298f89eaae7 https://doi.org/10.1128/jcm.37.9.3044-3047.1999

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Implication

Diagnostic comparative study reveals low sensitivity of rapid toxin A assays for Clostridium difficile diarrhea, indicating they are insufficient alone for accurate clinical detection.

Evaluation of Two Rapid Assays for Detection of Clostridium difficile Toxin A in Stool Specimens

Discussion

Member takes

Implication

Key Points

Cite This Study

Evaluation of Two Rapid Assays for Detection of Clostridium difficile Toxin A in Stool Specimens

Discussion

Member takes

Implication

Key Points

Cite This Study

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