Clinical application of polymerase chain reaction to diagnose Clostridium difficile in hospitalized patients with diarrhea

Morelli, Michael; Rouster, Susan D.; Giannella, Ralph A.; Sherman, Kenneth E.

doi:10.1016/s1542-3565(04)00290-3

Cited by 16 publications

(6 citation statements)

References 21 publications

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“…They can detect glutamate dehydrogenase (GDH) (so-called common antigen) and/or major toxins A and B and are inexpensive, rapid, and easy to perform. A drawback of EIA toxin tests is a lack of sensitivity (8,9,13,15,16,20,22,27,30,32). Conversely, EIA GDH tests have good sensitivity but lack specificity, as they cannot distinguish toxigenic from nontoxigenic C. difficile (8, 13, 15, 23-25, 30, 32).…”

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confidence: 99%

Loop-Mediated Isothermal Amplification Compared to Real-Time PCR and Enzyme Immunoassay for Toxigenic Clostridium difficile Detection

et al. 2012

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dClostridium difficile infection is the primary cause of health care-associated diarrhea. While most laboratories have been using rapid antigen tests for detecting C. difficile toxins, they have poor sensitivity; newer molecular methods offer rapid results with high test sensitivity and specificity. This study was designed to compare the performances of two molecular assays (Meridian illumigene and BD GeneOhm) and two antigen assays (Wampole Quik Chek Complete and TechLab Tox A/B II) to detect toxigenic C. difficile. Fecal specimens from hospitalized patients (n ‫؍‬ 139) suspected of having C. difficile infection were tested by the four assays. Nine specimens were positive and 109 were negative by all four methods. After discrepant analysis by toxigenic culture (n ‫؍‬ 21), the total numbers of stool specimens classified as positive and negative for toxigenic C. difficile were 21 (15%) and 118 (85%), respectively. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were as follows: GeneOhm (95.2%, 100%, 100%, and 99.2%), illumigene (95.2%, 96.6%, 83.3%, and 99.2%), Tox A/B II (52.4%, 97.5%, 78.6%, and 92.4%), and Quik Chek Complete (47.6%, 100%, 100%, and 91.9%). The illumigene assay performed comparably to the GeneOhm assay with a slight decrease in test specificity; the sensitivities of both far exceeded those of the antigen assays. The clinical characteristics of the concordant and discrepant study patients were similar, including stool consistency and frequency. In the era of rapid molecular-based tests for toxigenic C. difficile, toxin enzyme immunoassays (EIAs) should no longer be considered the standard of care.

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confidence: 99%

Loop-Mediated Isothermal Amplification Compared to Real-Time PCR and Enzyme Immunoassay for Toxigenic Clostridium difficile Detection

et al. 2012

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“…Neither study compared the BD GeneOhm Cdiff assay to a toxin ELISA, which is the most widely used diagnostic method for CDI, or to a two-step testing algorithm. Other studies of PCR assays reported in the literature utilized in-house tests with small numbers of positive results, making it difficult to propose general recommendations (1,5,9,15,17,23,26).…”

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confidence: 99%

Comparison of BD GeneOhm Cdiff Real-Time PCR Assay with a Two-Step Algorithm and a Toxin A/B Enzyme-Linked Immunosorbent Assay for Diagnosis of Toxigenic Clostridium difficile Infection

et al. 2010

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“…Clinicians have also been uneasy relying on a single negative CDTT result for patients at risk. This has led to numerous additional samples sent to the laboratory after an initial negative result (14). Other studies (4-6) using different methods have shown that there is little value in repeating CDTT within seven days of an initial result.…”

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confidence: 99%

“…This led physicians to request multiple stool samples that were sent on the same day or within a few days of the first sample. In one recent study (14), 57% of patients had more than one sample sent within a 24 h period. To examine the utility of repeat CDTT, the present study was designed to review all results over a continuous six-year period.…”

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The Value of Repeat Clostridium difficile Toxin Testing during and after an Outbreak of C difficile‐Associated Diarrhea

Dylewski

2011

Canadian Journal of Infectious Diseases and Medical Microbiolog

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Clinical application of polymerase chain reaction to diagnose Clostridium difficile in hospitalized patients with diarrhea

Cited by 16 publications

References 21 publications

Loop-Mediated Isothermal Amplification Compared to Real-Time PCR and Enzyme Immunoassay for Toxigenic Clostridium difficile Detection

Loop-Mediated Isothermal Amplification Compared to Real-Time PCR and Enzyme Immunoassay for Toxigenic Clostridium difficile Detection

Comparison of BD GeneOhm Cdiff Real-Time PCR Assay with a Two-Step Algorithm and a Toxin A/B Enzyme-Linked Immunosorbent Assay for Diagnosis of Toxigenic Clostridium difficile Infection

The Value of Repeat Clostridium difficile Toxin Testing during and after an Outbreak of C difficile‐Associated Diarrhea

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