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
            <i>Clostridium difficile</i>
            Infection

Kvach, Elizabeth J.; Ferguson, David; Riska, Paul; Landry, Marie L.

doi:10.1128/jcm.01630-09

Cited by 127 publications

(92 citation statements)

References 28 publications

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“…PCR is an excellent confi rmatory test for GDH compared with TC; no such data currently exist for LAMP testing ( 25,249,251 ). Amplifi cation methods, however, do have superior sensitivity compared with GDH, toxin A + B EIA, and CCNA tests ( 245,248 -251 ).…”

Section: Microbiological Testingmentioning

confidence: 99%

Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections

Surawicz

Brandt

Binion

et al. 2013

American Journal of Gastroenterology

1,468

1,408

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Clostridium diffi cile infection (CDI) is a leading cause of hospital-associated gastrointestinal illness and places a high burden on our health-care system. Patients with CDI typically have extended lengths-of-stay in hospitals, and CDI is a frequent cause of large hospital outbreaks of disease. This guideline provides recommendations for the diagnosis and management of patients with CDI as well as for the prevention and control of outbreaks while supplementing previously published guidelines. New molecular diagnostic stool tests will likely replace current enzyme immunoassay tests. We suggest treatment of patients be stratifi ed depending on whether they have mild-to-moderate, severe, or complicated disease. Therapy with metronidazole remains the choice for mildto-moderate disease but may not be adequate for patients with severe or complicated disease. We propose a classifi cation of disease severity to guide therapy that is useful for clinicians. We review current treatment options for patients with recurrent CDI and recommendations for the control and prevention of outbreaks of CDI. Am J Gastroenterol 2013; 108:478-498; doi: 10.1038/ajg.2013 12. In patients in whom oral antibiotics cannot reach a segment of the colon, such as with Hartman's pouch, ileostomy, or colon diversion, vancomycin therapy delivered via enema should be added to treatments above until the patient improves. (Conditional recommendation, low-quality evidence)13. The use of anti-peristaltic agents to control diarrhea from confi rmed or suspected CDI should be limited or avoided, as they may obscure symptoms and precipitate complicated disease. Use of anti-peristaltic agents in the setting of CDI must always be accompanied by medical therapy for CDI. (Strong recommendation, low-quality evidence) Management of severe and complicated CDI14. Supportive care should be delivered to all patients and includes intravenous fl uid resuscitation, electrolyte replacement, and pharmacological venous thromboembolism prophylaxis. Furthermore, in the absence of ileus or signifi cant abdominal distention, oral or enteral feeding should be continued. 17. Vancomycin delivered orally (500 mg four times per day) and per rectum (500 mg in a volume of 500 ml four times a day) plus intravenous metronidazole (500 mg three times a day) is the treatment of choice for patients with complicated CDI with ileus or toxic colon and / or signifi cant abdominal distention. (Strong recommendation, low-quality evidence)18. Surgical consult should be obtained in all patients with complicated CDI. Surgical therapy should be considered in patients with any one of the following attributed to CDI: hypotension requiring vasopressor therapy; clinical signs of sepsis and organ dysfunction (renal and pulmonary); mental status changes; white blood cell count ≥ 50,000 cells / μ l, lactate ≥ 5 mmol / l; or failure to improve on medical therapy after 5 days. (Strong recommendation, moderate-quality evidence) Management of recurrent CDI (RCDI)19. The fi rst recurrence of CDI can be treated ...

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Section: Microbiological Testingmentioning

confidence: 99%

Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections

Surawicz

Brandt

Binion

et al. 2013

American Journal of Gastroenterology

1,468

1,408

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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).…”

mentioning

confidence: 99%

“…Molecular assays directed at one or more of five genes residing within the pathogenicity locus (PaLoc) have fostered much interest. Commercial kit-based real-time PCR tests targeting the tcdB gene have recently become available-the BD GeneOhm Cdiff assay (Becton Dickinson), proGastro Cd (Gen-Probe/Prodesse), and Xpert C. difficile (Cepheid)-with exceptional performance and relative ease of use documented (5,8,9,13,(28)(29)(30)(31). FDA clearance was recently granted for the Meridian illumigene C. difficile assay, which uses loop-mediated isothermal amplification (LAMP) to detect the toxin A gene (tcdA) within the PaLoc.…”

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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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“…However, the cost can be 5-10 times greater than EIA for toxin A/B. Sensitivity has been 91% as compared to enzyme immunoassay at 67% [62] . Overall, sensitivity has been 84%-94% in comparison to TC, similar to the CCCN [60] .…”

Section: Laboratory Diagnosis Of CDImentioning

confidence: 99%

Clinical update for the diagnosis and treatment ofClostridium difficileinfection

Oldfield

Johnson

2014

WJGPT

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Clostridium difficile infection (CDI) presents a rapidly evolving challenge in the battle against hospitalacquired infections. Recent advances in CDI diagnosis and management include rapid changes in diagnostic approach with the introduction of newer tests, such as detection of glutamate dehydrogenase in stool and polymerase chain reaction to detect the gene for toxin production, which will soon revolutionize the diagnostic approach to CDI. New medications and multiple medical society guidelines have introduced changing concepts in the definitions of severity of CDI and the choice of therapeutic agents, while rapid expansion of data on the efficacy of fecal microbiota transplantation heralds a revolutionary change in the management of patients suffering multiple relapses of CDI. Through a comprehensive review of current medical literature, this article aims to offer an intensive review of the current state of CDI diagnosis, discuss the strengths and limitations of available laboratory tests, compare both current and future treatments options and offer recommendations for best practice strategies.

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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

Cited by 127 publications

References 28 publications

Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections

Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections

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

Clinical update for the diagnosis and treatment ofClostridium difficileinfection

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