Evaluation of 3 automated real-time PCR (Xpert C. difficile assay, BD MAX Cdiff, and IMDx C. difficile for Abbott m2000 assay) for detecting Clostridium difficile toxin gene compared to toxigenic culture in stool specimens

Yoo, Jaeeun; Lee, Hyeyoung; Park, Kang Gyun; Lee, Gun Dong; Park, Yong Gyu; Park, Yeon-Joon

doi:10.1016/j.diagmicrobio.2015.05.005

Cited by 17 publications

(9 citation statements)

References 13 publications

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“…The literature demonstrates variability in the performance characteristics of currently available molecular assays for C. difficile detection, with sensitivities and PPA, compared to TC, ranging from 81.6% to 100% (9,(12)(13)(14)(15)(16)(17). This wide range is likely due to a variety of factors, including bacterial load, targeted patient populations, and the sensitivity of the comparative culture method, since there is no agreed-upon or approved standard method.…”

Section: Discussionmentioning

confidence: 99%

“…This wide range is likely due to a variety of factors, including bacterial load, targeted patient populations, and the sensitivity of the comparative culture method, since there is no agreed-upon or approved standard method. Utilization of molecular assays has suggested that many "gold standard" methods miss samples due to low tcdB copy numbers that are below the limit of detection for the culture and antigen methods (14,15,18). The PPA observed in our study (85%) was comparable to those in other studies addressing the performance of molecular detection of C. difficile, including studies with the Xpert C. difficile assay (82.8% or 90%) (14,15), the BD MAX Cdiff assay (81.6% to 89.3%) (12,14,15,17), the Simplexa C. difficile assay (87.4%) (17), and the Illumigene C. difficile assay (82.4% or 86.7%) (15,18).…”

Section: Discussionmentioning

confidence: 99%

“…Utilization of molecular assays has suggested that many "gold standard" methods miss samples due to low tcdB copy numbers that are below the limit of detection for the culture and antigen methods (14,15,18). The PPA observed in our study (85%) was comparable to those in other studies addressing the performance of molecular detection of C. difficile, including studies with the Xpert C. difficile assay (82.8% or 90%) (14,15), the BD MAX Cdiff assay (81.6% to 89.3%) (12,14,15,17), the Simplexa C. difficile assay (87.4%) (17), and the Illumigene C. difficile assay (82.4% or 86.7%) (15,18). However, other studies regularly observed sensitivities and PPA over 90% for C. difficile molecular assays, including the Xpert C. difficile assay (93.5% to 100%) (9,12,16,17), the Illumigene C. difficile assay (91.8%) (19), the BD GeneOhm Cdiff assay (95.5%) (18), and the Verigene CDF assay (5.2%) (17).…”

Section: Discussionmentioning

confidence: 99%

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A Multicenter Study of the Revogene C. difficile System for Detection of the Toxin B Gene from Unformed Stool Specimens

et al. 2020

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Clostridioides difficile is the leading cause of diarrhea in hospitalized U.S. patients and results in over 400,000 cases of C. difficile infection per year. C. difficile infections have mortality rates of 6 to 30% and significantly increase health care costs, because of increased length of stay and increased frequency of readmissions due to recurrences. Efforts to reduce the spread of C. difficile in hospitals have led to the development of rapid sensitive diagnostic methods. A multicenter study was performed to establish the performance characteristics of the Revogene C. difficile test (Meridian Bioscience, Cincinnati, OH, USA) for use in detection of the toxin B (tcdB) gene from toxigenic C. difficile. The Revogene instrument is a new molecular platform that uses real-time PCR to detect nucleic acids in up to 8 specimens at a time. A total of 2,461 specimens from symptomatic patients that had been submitted for C. difficile testing were enrolled at 7 sites throughout the United States and Canada for evaluation of the assay. Each stool specimen was tested for the presence of the tcdB gene using the Revogene C. difficile test, and results were compared with those of the reference method, a combination of direct and enriched culture methods. Overall, the Revogene C. difficile test demonstrated a sensitivity of 85.0% (95% confidence interval, 80% to 88%) and a specificity of 97.2% (95% confidence interval, 96% to 98%). The Revogene C. difficile test, using clinical stool specimens for detection of tcdB in C. difficile, demonstrated acceptable sensitivity and specificity, with a short turnaround time.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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A Multicenter Study of the Revogene C. difficile System for Detection of the Toxin B Gene from Unformed Stool Specimens

et al. 2020

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“…However, when IMDx and 2 other molecular assays were compared to TC, IMDx had the lowest sensitivity (62.1%) and the highest specificity (99.4%)[93]. …”

Section: Diagnostic Testsmentioning

confidence: 99%

“…In the same study, ribotyping was assessed, but there were no significant differences between the sensitivities and specificities of different ribotypes[94]. When the BD Max Cdiff Assay and 2 other molecular assays were compared to TC, the BD Max Cdiff Assay had a sensitivity of 81.6% and a specificity of 95.8%[93]. …”

Section: Diagnostic Testsmentioning

confidence: 99%

Current knowledge on the laboratory diagnosis ofClostridium difficileinfection

Martínez-Meléndez¹,

Camacho-Ortíz²,

Morfín‐Otero³

et al. 2017

WJG

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Clostridium difficile (C. difficile) is a spore-forming, toxin-producing, gram-positive anaerobic bacterium that is the principal etiologic agent of antibiotic-associated diarrhea. Infection with C. difficile (CDI) is characterized by diarrhea in clinical syndromes that vary from self-limited to mild or severe. Since its initial recognition as the causative agent of pseudomembranous colitis, C. difficile has spread around the world. CDI is one of the most common healthcare-associated infections and a significant cause of morbidity and mortality among older adult hospitalized patients. Due to extensive antibiotic usage, the number of CDIs has increased. Diagnosis of CDI is often difficult and has a substantial impact on the management of patients with the disease, mainly with regards to antibiotic management. The diagnosis of CDI is primarily based on the clinical signs and symptoms and is only confirmed by laboratory testing. Despite the high burden of CDI and the increasing interest in the disease, episodes of CDI are often misdiagnosed. The reasons for misdiagnosis are the lack of clinical suspicion or the use of inappropriate tests. The proper diagnosis of CDI reduces transmission, prevents inadequate or unnecessary treatments, and assures best antibiotic treatment. We review the options for the laboratory diagnosis of CDI within the settings of the most accepted guidelines for CDI diagnosis, treatment, and prevention of CDI.

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Laboratory Technical Advances in the Diagnosis of Clostridium difficile

Mizusawa¹,

Carroll²

2018

Advanced Techniques in Diagnostic Microbiology

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Evaluation of 3 automated real-time PCR (Xpert C. difficile assay, BD MAX Cdiff, and IMDx C. difficile for Abbott m2000 assay) for detecting Clostridium difficile toxin gene compared to toxigenic culture in stool specimens

Cited by 17 publications

References 13 publications

A Multicenter Study of the Revogene C. difficile System for Detection of the Toxin B Gene from Unformed Stool Specimens

A Multicenter Study of the Revogene C. difficile System for Detection of the Toxin B Gene from Unformed Stool Specimens

Current knowledge on the laboratory diagnosis ofClostridium difficileinfection

Laboratory Technical Advances in the Diagnosis of Clostridium difficile

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