Multicenter Clinical Evaluation of the Portrait Toxigenic C. difficile Assay for Detection of Toxigenic Clostridium difficile Strains in Clinical Stool Specimens

Buchan, Blake W.; Mackey, Tami-Lea A.; Daly, Judy A.; Alger, Garrison; Denys, Gerald A.; Peterson, Lance R.; Kehl, Sue C.; Ledeboer, Nathan A.

doi:10.1128/jcm.02083-12

Cited by 36 publications

(31 citation statements)

References 15 publications

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“…Assay characteristics did not, however, differ significantly. The data for the BD MAX Cdiff assay were comparable to those from a previous study (7), and both molecular assays confirmed the high sensitivity and specificity rates of C. difficile PCR assays (3,5,(14)(15)(16)(17)(18). Also, no differences were observed when the Xpert C. difficile and the BD GeneOhm Cdiff assays were compared (19); thus, equal performance of all three assays can be assumed.…”

supporting

confidence: 73%

“…Five patients received a relevant antibiotic treatment that might explain false-positive PCR detection of DNA from dead bacteria. However, 3 patients provided other samples that were culture positive, arguing that molecular detection was truly more sensitive (14,21). Seven true-positive samples were missed by the BD MAX Cdiff assay; of those, 6 were positive by the Xpert assay.…”

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confidence: 99%

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Evaluation of the Fully Automated BD MAX Cdiff and Xpert C. difficile Assays for Direct Detection of Clostridium difficile in Stool Specimens

et al. 2013

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We evaluated the fully automated molecular BD MAX Cdiff assay (BD Diagnostics) and the Xpert C. difficile test (Cepheid) for rapid detection of Clostridium difficile infection. Culture was done on chromogenic agar followed by matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry identification and toxin detection. Repeat testing was required for 1.8% and 6.0% of the BD MAX and Xpert tests, respectively. Sensitivities, specificities, positive predictive values (PPV), and negative predictive values (NPV) were 90.5%, 97.9%, 89.3%, and 98.1%, respectively, for BD MAX and 97.3%, 97.9%, 90.0%, and 99.5%, respectively, for Xpert. Clostridium difficile is the most important cause of hospitalacquired diarrhea. To implement timely infection control measures and appropriate treatment, rapid identification of toxigenic C. difficile is necessary (1). However, laboratory diagnostics remain challenging, as rapid test procedures relying on enzyme immunoassays (EIAs) show limited sensitivity (2), whereas the more-sensitive toxigenic culture and cytotoxicity assays are demanding and time-consuming. Two-step algorithms consisting of sensitive detection of glutamate dehydrogenase followed by a confirmatory toxin test have been proposed (2-4), yet the actual sensitivity has been questioned (5). Nucleic acid amplification techniques have been developed to combine low turnaround times with high sensitivity (6), but these assays require specific infrastructure. More recently, fully automated PCR assays that combine nucleic acid extraction, amplification, and detection have been developed. The Xpert C. difficile assay (Cepheid, Sunnyvale, CA) has high sensitivity and specificity and allows for accurate and rapid detection of Clostridium difficile infection (CDI). Recently, the BD MAX platform (BD Diagnostics, Franklin Lakes, NJ) has been made available; this allows for processing up to 24 samples in a fully automated PCR system. Clinical evaluation of the BD MAX Cdiff assay, based on detection of tcdB, has been published only for comparison with the BD GeneOhm assay (7).This study was conducted between April and July 2012 at the 2,000-bed tertiary care University Hospital Heidelberg. From 333 individual patients, 448 stool specimens, mostly (94.9%) soft or liquid, were examined. Samples were analyzed upon delivery or after overnight storage at 4°C. Specimens were analyzed by the BD MAX Cdiff assay and the Xpert C. difficile test. The standard technique used by the microbiology laboratory as the routine assay was the toxin A/B EIA (miniVIDAS; bioMérieux, Marcy l'Etoile, France). For the BD MAX Cdiff assay, stool samples were vortexed for 15 s and a 10-l loop was used to inoculate the sample tube. The Xpert C. difficile test and the miniVIDAS assay were done strictly in accordance with the manufacturers' protocols. As the reference method (8), stool samples were streaked onto chromID C. difficile agar plates (bioMérieux), incubated anaerobically at 35°C, and read after 24 and 48 h (9, 10). Suspicious col...

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supporting

confidence: 73%

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confidence: 99%

Evaluation of the Fully Automated BD MAX Cdiff and Xpert C. difficile Assays for Direct Detection of Clostridium difficile in Stool Specimens

et al. 2013

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“…After reviewing the titles and abstracts, 21 articles were selected for full-text evaluation (Figure 1). Sixteen articles with 18 studies published between 2005 and 2014 reported the sensitivity and specificity of LAMP on stool samples for the diagnosis of C. difficile infection, and were included in our meta-analysis [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37]. Five articles were excluded (reasons for exclusion in Figure 1).…”

Section: Study Characteristicsmentioning

confidence: 99%

Accuracy of loop-mediated isothermal amplification for the diagnosis of Clostridium difficile infection: a systematic review

Lloyd

Pasupuleti

Thota

et al. 2015

Diagnostic Microbiology and Infectious Disease

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CitationLloyd A, Pasupuleti V, Thota P, Pant C, Rolston DDK, Hernandez A V., et al. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPT

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“…It would take only a few additional false results to make the platform appear less sensitive or specific. Despite the fact that there are some significant differences between platforms, the results with all platforms compare favorably to those obtained with other molecular assays for the detection of C. difficile, as evidenced by the product inserts and many additional clinical studies (11,(17)(18)(19)(20)(21)(22)(23)(24).…”

Section: Discussionmentioning

confidence: 52%

“…These assays can be performed within a few hours, but they lack sensitivity and specificity, and the GDH assays cannot differentiate between cytotoxic and noncytotoxic strains of C. difficile. EIAs are not recommended as the sole diagnostic for detection of C. difficile disease (1,(7)(8)(9)(10)(11). Cell culture cytotoxicity neutralization assays (CCNA) detect the presence of C. difficile cytotoxin by inoculating cell cultures with clarified stool specimens in the presence and absence of C. difficile antitoxins and can take up to 48 h to complete.…”

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confidence: 99%

Multicenter Evaluation of the Quidel Lyra Direct C. difficile Nucleic Acid Amplification Assay

Beck¹,

Buchan

Riebe³

et al. 2014

J Clin Microbiol

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dClostridium difficile is a Gram-positive bacterium commonly found in health care and long-term-care facilities and is the most common cause of antibiotic-associated diarrhea. Rapid detection of this bacterium can assist physicians in implementing contact precautions and appropriate antibiotic therapy in a timely manner. The purpose of this study was to compare the clinical performance of the Quidel Lyra Direct C. difficile assay (Lyra assay) (Quidel, San Diego, CA) to that of a direct cell culture cytotoxicity neutralization assay (CCNA) and enhanced toxigenic culture. This study was performed at three geographically diverse laboratories within the United States using residual stool specimens submitted for routine C. difficile testing. Residual samples were tested using the Lyra assay on three real-time PCR platforms, and results were compared to those for direct CCNA and enhanced toxigenic culture. The test results for all platforms were consistent across all three test sites. The sensitivity and specificity of the Lyra assay on the SmartCycler II, ABI 7500 Fast DX, and ABI QuantStudio DX instruments compared to CCNA were 90.0% and 93.3%, 95.0% and 94.2%, and 93.8% and 95.0%, respectively. Compared to enhanced toxigenic culture, the sensitivity and specificity of the Lyra assay on the SmartCycler II, ABI 7500, and QuantStudio instruments were 82.1% and 96.9%, 89.3% and 98.8%, and 85.7% and 99.0%, respectively. Overall, the Lyra assay is easy to use and versatile and compares well to C. difficile culture methods.

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Multicenter Clinical Evaluation of the Portrait Toxigenic C. difficile Assay for Detection of Toxigenic Clostridium difficile Strains in Clinical Stool Specimens

Cited by 36 publications

References 15 publications

Evaluation of the Fully Automated BD MAX Cdiff and Xpert C. difficile Assays for Direct Detection of Clostridium difficile in Stool Specimens

Evaluation of the Fully Automated BD MAX Cdiff and Xpert C. difficile Assays for Direct Detection of Clostridium difficile in Stool Specimens

Accuracy of loop-mediated isothermal amplification for the diagnosis of Clostridium difficile infection: a systematic review

Multicenter Evaluation of the Quidel Lyra Direct C. difficile Nucleic Acid Amplification Assay

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