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Clostridium difficile Infections: Diagnosis, Treatment, and Prevention

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Results of Direct Comparisons of Available Diagnostic Assays

Ten studies directly compared at least two immunoassays for toxins A and B, providing 16 pair wise comparisons of seven different immunoassays. Comparative data were not found for many currently used tests. There were no statistical differences between the sensitivities of immunoassays that were compared; however, the estimates of the differences in sensitivity were not very precise and could not rule out substantial differences. Substantial differences in false positives, that is, specificity, were not found among the tests that were compared. Four studies compared at least one toxin gene detection test to at least one immunoassay for toxins A and B, providing a total of nine direct comparisons. Comparative data were not always available for the three currently available gene detection tests. The gene detection tests could be substantially more sensitive than many immunoassays for toxins A and B, but may lose specificity. Therefore, better studies are needed. Insufficient patient information was provided in reports of comparative data.