Results of a prospective, 18-month clinical evaluation of culture, cytotoxin testing, and culturette brand (CDT) latex testing in the diagnosis of Clostridium difficile-associated diarrhea

Peterson, Lance R.; Olson, Mary M.; Shanholtzer, Carol J.; Gerding, Dale N.

doi:10.1016/0732-8893(88)90045-4

Cited by 59 publications

(36 citation statements)

References 35 publications

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“…However, recent reports have highlighted the lack of sensitivity of the toxin A/B EIAs, which show sensitivities as low as 48% (2,28). Although toxigenic culture of the organism has now been reaccepted as the true gold standard (25), this method requires substantial laboratory resources, and results are not available in a short enough time frame to be clinically useful (18,24,28). Thus, other approaches to improving both the sensitivity and the cost-effectiveness of C. difficile testing have been introduced (2,22).…”

mentioning

confidence: 99%

Clostridium difficile Testing in the Clinical Laboratory by Use of Multiple Testing Algorithms

Novak-Weekley¹,

Marlowe²,

Miller³

et al. 2010

J Clin Microbiol

205

147

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The incidence of Clostridium difficile infection (CDI) has risen almost 3-fold in the United States over the past decade, emphasizing the need for rapid and accurate tests for CDI. The Cepheid Xpert C. difficile assay is an integrated, closed, nucleic acid amplification system that automates sample preparation and real-time PCR detection of the toxin B gene (tcdB). A total of 432 stool specimens from symptomatic patients were tested by a glutamate dehydrogenase (GDH) assay, a toxin A and B enzyme immunoassay (EIA), the Xpert C. difficile assay, and a cell culture cytotoxicity neutralization assay (CCCN). The results of these methods, used individually and in combination, were compared to those of toxigenic culture. Results for the Xpert C. difficile assay alone showed a sensitivity, specificity, positive predictive value, and negative predictive value (NPV) of 94.4, 96.3, 84.0, and 98.8%, while the EIA alone gave corresponding values of 58.3, 94.7, 68.9, and 91.9%, respectively. An algorithm using the GDH assay and the EIA (plus the CCCN if the EIA was negative) showed corresponding values of 83.1, 96.7, 83.1, and 96.1%. The Xpert C. difficile assay was statistically superior to the EIA (P, <0.001 by Fisher's exact test) and to the GDH-EIA-CCCN algorithm (P, 0.0363). Combining the GDH and Xpert C. difficile assays lowered both the sensitivity and the NPV of the Xpert assay. The GDH-EIA-CCCN procedure required, on average, 2 days to complete testing on GDH-positive results, while testing by the Xpert C. difficile assay was completed, on average, in less than 1 h. Xpert C. difficile testing yielded the highest sensitivity and NPV, in the least amount of time, of the individual-and multiple-test algorithms evaluated in this study.

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confidence: 99%

Clostridium difficile Testing in the Clinical Laboratory by Use of Multiple Testing Algorithms

Novak-Weekley¹,

Marlowe²,

Miller³

et al. 2010

J Clin Microbiol

205

147

View full text Add to dashboard Cite

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“…Many of these approaches incorporate cytotoxicity neutralization (CTN) assays or anaerobic agar culture with identification of the organism, followed by toxin testing. However, many laboratories do not have the technical expertise, facilities, or training to perform CTN assays (which are labor-intensive and somewhat subjective), and an anaerobic agar culture with toxin detection may take several days; both of these methods delay the reporting of results (14,17,19,20,21,29). The use of PCR for the diagnosis of this disease has been shown to be very specific and sensitive but often does not allow for randomaccess (i.e., real-time) results and can be quite costly to perform as a stand-alone testing method (2,6,10,12,15,17,27,28).…”

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

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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.

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“…1,2,5 Strains of C. difficile that do not produce toxins are common and considered nonpathogenic, which is why culture methods alone are not sufficient for diagnosis of CDI. Both older published results 32 and the conclusions of newer studies 2,5 suggest that the CCCN test lacks adequate sensitivity for detection of toxin-producing strains, partially because of the degradation of the toxin over time. 43 Eastwood et al 2 compared the results of EIA, CCCN, and toxigenic culture for detection of C. difficile from a series of stool samples.…”

Section: Cccn Testmentioning

confidence: 99%

“…43 Toxin A and, especially, toxin B are subject to time-dependent degradation due to proteolysis and pH effects. 32 Although these proteins are generally stable in stool at 4°C, this is not the ambient temperature of the gastrointestinal tract, within which degradation is probably a continuous process. Specimens may sit for several minutes to hours at room temperature in a bedpan before being placed in a transport container and sent to the laboratory for processing.…”

Section: Why Are There Disparities In the Published Reports Of Test Pmentioning

confidence: 99%

Laboratory Diagnosis of Clostridium difficile Infection

Tenover¹,

Baron²,

Peterson

et al. 2011

The Journal of Molecular Diagnostics

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The laboratory diagnosis of Clostridium difficile infection (CDI) continues to be challenging. Recent guidelines from professional societies in the United States note that enzyme immunoassays for toxins A and B do not have adequate sensitivity to be used alone for detecting CDI, yet the optimal method for diagnosing this infection remains unclear. Nucleic acid amplification tests (NAATs) that target chromosomal toxin genes (usually the toxin B gene, tcdB) show high sensitivity and specificity, provide rapid results, and are amenable to both batch and on-demand testing, but these tests were not universally recommended for routine use in the recent guidelines. Rather, two-step algorithms that use glutamate dehydrogenase (GDH) assays to screen for C. difficile in stool specimens, followed by either direct cytotoxin testing or culture to identify toxin-producing C. difficile isolates, were recommended in one guideline and either GDH algorithms or NAATs were recommended in another guideline. Unfortunately, neither culture nor direct cytotoxin testing is widely available. In addition, this two-step approach requires 48 to 92 hours to complete, which may delay the initiation of therapy and critical infection control measures. Recent studies also show the sensitivity of several GDH assays to be <90%. This review considers the role of NAATs for diagnosing CDI and explores their potential advantages over two-step algorithms, including shorter time to results, while providing comparable, if not superior, accuracy.

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Results of a prospective, 18-month clinical evaluation of culture, cytotoxin testing, and culturette brand (CDT) latex testing in the diagnosis of Clostridium difficile-associated diarrhea

Cited by 59 publications

References 35 publications

Clostridium difficile Testing in the Clinical Laboratory by Use of Multiple Testing Algorithms

Clostridium difficile Testing in the Clinical Laboratory by Use of Multiple Testing Algorithms

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

Laboratory Diagnosis of Clostridium difficile Infection

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