Rapid and Reliable Diagnostic Algorithm for Detection of
            <i>Clostridium difficile</i>

Fenner, Lukas; Widmer, Andreas F.; Goy, Gisela; Rudin, Sonja; Frei, Reno

doi:10.1128/jcm.01503-07

Cited by 132 publications

(101 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…As reported by others, we found that both toxin assays (the LF-TOX and COMP-TOX assays) had poor sensitivities (59.5% and 61.9%, respectively), although they were both highly specific (1,3,4,5,16). However, both GDH assays proved to be highly sensitive in our study, having sensitivities of from 97.6 to 100%.…”

Section: Discussionsupporting

confidence: 63%

“…These assays include enzyme immunoassays (EIAs), lateral flow tests, PCR assays, tissue culture cytotoxicity neutralization tests, and toxigenic culture. Many recent papers have reported on the use of different algorithms that use the tests mentioned above to allow the better diagnosis of C. difficile disease (4,5,8,18,19,20,23,26). Many of these approaches incorporate cytotoxicity neutralization (CTN) assays or anaerobic agar culture with identification of the organism, followed by toxin testing.…”

mentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of the C.Diff Quik Chek Complete Assay, a New Glutamate Dehydrogenase and A/B Toxin Combination Lateral Flow Assay for Use in Rapid, Simple Diagnosis of Clostridium difficile Disease

et al. 2010

View full text Add to dashboard Cite

The diagnosis of Clostridium difficile infection continues to be a challenge for many clinical microbiology laboratories. A new lateral flow assay, the C.Diff Quik Chek Complete assay, which tests for the presence of both glutamate dehydrogenase (GDH) and C. difficile toxins A and B, was evaluated for its ability to diagnose C. difficile disease. The results of this assay were compared to those of both PCR and toxigenic culture. The results showed that this assay allows 88% of specimens to be accurately screened as either positive (both tests positive) or negative (both tests negative) for the presence of toxigenic C. difficile in less than 30 min and with minimal hands-on time. Use of a random-access PCR for the analysis of specimens with discrepant results (one test positive and the other negative) allows the easy, rapid, and highly sensitive (100%; 95% confidence interval [CI], 89.6 to 100%) and specific (99.6%; 95% CI, 97.3 to 99.9%) diagnosis of C. difficile disease. The use of this algorithm would save institutional costs, curtail unnecessary isolation days, reduce the nosocomial transmission of disease, and increase the quality of care for patients.

show abstract

Section: Discussionsupporting

confidence: 63%

mentioning

confidence: 99%

Evaluation of the C.Diff Quik Chek Complete Assay, a New Glutamate Dehydrogenase and A/B Toxin Combination Lateral Flow Assay for Use in Rapid, Simple Diagnosis of Clostridium difficile Disease

et al. 2010

View full text Add to dashboard Cite

show abstract

“…When using glutamate dehydrogenase (GDH) EIA followed by a toxin detection immunoassay for positive cases, the sensitivity was over 96% and reached 100% when a tissue culture cytotoxin assay was used for GDH-positive, toxin-negative cases (22). Similar findings were observed in a study performed by Fenner et al (9). Other groups urge the use of a two-step method, but instead of using a toxin EIA, a cell culture cytotoxicity neutralization assay was used (18,23).…”

Section: Discussionsupporting

confidence: 55%

Evaluation of Repeat Clostridium difficile Enzyme Immunoassay Testing

Cardona

Rand

2008

J Clin Microbiol

View full text Add to dashboard Cite

Clostridium difficile is the leading cause of antibiotic-associated diarrhea and pseudomembranous colitis, which have significant morbidity and mortality. Accurate and timely diagnosis is critical. Repeat enzyme immunoassay testing for C. difficile toxin has been recommended because of <100% sensitivity. All C. difficile tests between 1 January 2006 and 31 December 2006 were retrospectively analyzed for results and testing patterns. The Wampole C. difficile Tox A/B II enzyme immunoassay kit was used. There were a total of 8,256 tests from 3,112 patients; 49% of tests were repeated. Of the 3,749 initially negative patient tests, 96 were positive upon repeat testing within 10 days of the first test. Of repeat tests, 0.9% repeated on day 0 (same day as the first test), 1.8% on day 1, 3.8% on day 2, 2.6% on day 3, 5.4% on days 4 to 6, and 10.6% on days 7 to 10 were positive. Thirty-eight patients had a positive test within 48 h of an initial negative test, and based on chart review, 18 patients were treated empirically while 16 were treated following the new result. None had evidence of medical complications. Of initially positive patients, 91% were positive upon repeat testing on day 0, 75% on day 1, and 58% on day 2, to a low of 14% on days 7 to 10. Depending on the clinical setting, these data support not repeating C. difficile tests within 2 days of a negative result and limiting repeat testing to >1 week of a positive result.

show abstract

“…Among 401 clinical stool specimens tested in our study, 53 (13.2%) specimens were positive by qTC, and the toxigenic C. difficile loads ranged from 3.00 ϫ 10 1 to 3.69 ϫ 10 6 CFU/ml (Table 3). A total of 90.5% of C. difficile were toxin-producing isolates, similar to the value reported by Fenner et al (32). There was no significant difference in the relative standard deviations of the low, medium, and high bacterial load groups (P Ͼ 0.05).…”

Section: Discussionsupporting

confidence: 88%

Real-Time Cellular Analysis Coupled with a Specimen Enrichment Accurately Detects and Quantifies Clostridium difficile Toxins in Stool

Huang

Jin

Zhang³

et al. 2014

J Clin Microbiol

View full text Add to dashboard Cite

We describe here the use of an immunomagnetic separation enrichment process coupled with a modified real-time cellular analysis (RTCA) system (RTCA version 2) for the detection of C. difficile toxin (CDT) in stool. The limit of CDT detection by RTCA version 2 was 0.12 ng/ml. Among the consecutively collected 401 diarrheal stool specimens, 53 (13.2%) were toxin-producing C. difficile strains by quantitative toxigenic culture (qTC); bacterial loads ranged from 3.00 ؋ 10 1 to 3.69 ؋ 10 6 CFU/ml. The RTCA version 2 method detected CDT in 51 samples, resulting in a sensitivity of 96.2%, a specificity of 99. C lostridium difficile infection (CDI) is the leading bacterial cause of nosocomial diarrhea in hospitalized patients (1-4). The incidence of CDI has increased in the last decade and community onset disease has been encountered in patients without previous health care exposure or antibiotic use (5-7).A definitive laboratory diagnosis of CDI depends on a stool test result positive for the presence of toxigenic C. difficile or its toxins (CDT) or colonoscopic or histopathologic findings demonstrating pseudomembranous colitis (8). Currently, laboratory methods used for the diagnosis of CDI are based on detection of C. difficile-specific antigen (e.g., glutamate dehydrogenase enzyme immunoassay [EIA]), toxin proteins (toxin A/B EIA, toxigenic culture [TC], cell cytotoxicity neutralization assay [CCNA]), or toxin genes (real-time PCR [RT-PCR] and loop-mediated isothermal amplification assay) (9-14). Molecular diagnostic techniques, including RT-PCR and other molecular assays, have the advantages of higher sensitivities and rapid turnaround times and are increasingly being implemented for routine diagnostic use (15-17).While molecular-based tests have high sensitivity and are faster, these assays detect the presence of toxin-encoding genes, and they may not be able to distinguish between infection and colonization as well as live and dead C. difficile organisms in certain circumstances (18,19). Recent studies highlighted the importance of detecting and quantifying CDT (20,21). Planche et al. recently noted no increase in mortality when toxigenic C. difficile alone was present, while toxin determined by cytotoxin assay positivity correlated with clinical outcome. CDT correlated with the clinical severity of CDI (21). Leslie et al. found that toxin-negative patients had a lower level of C. difficile than toxin-positive patients (22). These results suggested that toxin quantification could be used clinically to predict toxin status and help distinguish patients with CDI from carriers with diarrhea due to other causes (21).We previously reported on the use of a real-time cellular analysis (RTCA) assay (ACEA Biosciences, San Diego, CA) for quantitative detection of CDT directly from stool (23). This assay is based on microelectronic sensor-based cellular analysis technology (23). Cell index (CI) is a dimensionless parameter to represent cell status based on the change of the electrode impedance. The impedance readout harness...

show abstract

Rapid and Reliable Diagnostic Algorithm for Detection of Clostridium difficile

Cited by 132 publications

References 14 publications

Evaluation of the C.Diff Quik Chek Complete Assay, a New Glutamate Dehydrogenase and A/B Toxin Combination Lateral Flow Assay for Use in Rapid, Simple Diagnosis of Clostridium difficile Disease

Evaluation of the C.Diff Quik Chek Complete Assay, a New Glutamate Dehydrogenase and A/B Toxin Combination Lateral Flow Assay for Use in Rapid, Simple Diagnosis of Clostridium difficile Disease

Evaluation of Repeat Clostridium difficile Enzyme Immunoassay Testing

Real-Time Cellular Analysis Coupled with a Specimen Enrichment Accurately Detects and Quantifies Clostridium difficile Toxins in Stool

Contact Info

Product

Resources

About