Clinical Utility of Laboratory Detection of Clostridium difficile Strain BI/NAP1/027

Kociolek, Larry K.; Gerding, Dale N.

doi:10.1128/jcm.02340-15

Cited by 21 publications

(14 citation statements)

References 34 publications

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“…Toxin concentrations may reflect only one of many 027 virulence factors, while increased sporulation capacity (31) and fluoroquinolone administration (32) may drive separate virulence mechanisms. The need for 027 genotyping is not currently recommended for routine clinical laboratories diagnosing nonepidemic CDI cases (33).…”

Section: Discussionmentioning

confidence: 99%

Ultrasensitive Detection of Clostridioides difficile Toxins A and B by Use of Automated Single-Molecule Counting Technology

Sandlund¹,

Bartolome²,

Almazan³

et al. 2018

J Clin Microbiol

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Current tests for the detection of (formerly) free toxins in feces lack sensitivity, while nucleic acid amplification tests lack clinical specificity. We have evaluated the Singulex Clarity C. diff toxins A/B assay (currently in development), an automated and rapid ultrasensitive immunoassay powered by single-molecule counting technology, for detection of toxin A (TcdA) and toxin B (TcdB) in stool. The analytical sensitivity, analytical specificity, repeatability, and stability of the assay were determined. In a clinical evaluation, frozen stool samples from 311 patients with suspected infection were tested with the Clarity C. diff toxins A/B assay, using an established cutoff value. Samples were tested with the Xpert assay, and PCR-positive samples were tested with an enzyme immunoassay (EIA) (C. Diff Quik Chek Complete). EIA-negative samples were further tested with a cell cytotoxicity neutralization assay. The limits of detection for TcdA and TcdB were 0.8 and 0.3 pg/ml in buffer and 2.0 and 0.7 pg/ml in stool, respectively. The assay demonstrated reactivity to common strains, did not show cross-reactivity to common gastrointestinal pathogens, was robust against common interferents, allowed detection in fresh and frozen stool samples and in samples after three freeze-thaw cycles, and provided results with high reproducibility. Compared to multistep PCR and toxin-testing procedures, the Singulex Clarity C. diff toxins A/B assay yielded 97.7% sensitivity and 100% specificity. The Singulex Clarity C. diff toxins A/B assay is ultrasensitive and highly specific and may offer a standalone solution for rapid detection and quantitation of free toxins in stool.

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Section: Discussionmentioning

confidence: 99%

Ultrasensitive Detection of Clostridioides difficile Toxins A and B by Use of Automated Single-Molecule Counting Technology

Sandlund¹,

Bartolome²,

Almazan³

et al. 2018

J Clin Microbiol

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“…he increased frequency, morbidity, and mortality of Clostridium difficile infections (CDI) in adults over the past 2 decades are primarily attributable to the emergence and global spread of a fluoroquinolone-resistant strain known as BI/NAP1/027 (1,2). CDI is now the most frequently encountered health care-associated infection in the United States (3), causing nearly 500,000 infections and 30,000 deaths each year (4).…”

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confidence: 99%

Differences in the Molecular Epidemiology and Antibiotic Susceptibility of Clostridium difficile Isolates in Pediatric and Adult Patients

Kociolek

Gerding

Osmolski

et al. 2016

Antimicrob Agents Chemother

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fThe rising incidence of Clostridium difficile infections (CDIs) in adults is partly related to the global spread of fluoroquinoloneresistant strains, namely, BI/NAP1/027. Although CDIs are also increasingly diagnosed in children, BI/NAP1/027 is relatively uncommon in children. Little is known about the antibiotic susceptibility of pediatric CDI isolates. C. difficile was cultured from tcdB-positive stools collected from children diagnosed with CDI between December 2012 and December 2013 at an academic children's hospital. CDI isolates were grouped by restriction endonuclease analysis (REA). MICs were measured by agar dilution method for 7 antibiotics. Susceptibility breakpoints were based on guidelines from CLSI and/or the European Committee on Antimicrobial Susceptibility Testing (EUCAST). MICs and REA groupings of C. difficile isolates from 74 adult patients (29 isolates underwent REA) from a temporally and geographically similar adult cohort were compared to those of pediatric isolates. Among 122 pediatric and 74 adult isolates, respectively, the rates of resistance were as follows: metronidazole, 0% and 0%; vancomycin, 0% and 8% (P ‫؍‬ 0.003); rifaximin, 1.6% and 6.7% (P ‫؍‬ 0.11); clindamycin, 18.9% and 25.3% (P ‫؍‬ 0.29); and moxifloxacin, 2.5% and 36% (P ‫؍‬ <0.0001). Only 1 of 122 (0.8%) BI/NAP1/027 isolates was identified among the children, compared to 9 of 29 (31%) isolates identified among the adults (P ‫؍‬ <0.0001). The 3 moxifloxacin-resistant pediatric isolates were of REA groups BI and CF and a nonspecific group. The 2 rifaximin-resistant pediatric isolates were of REA groups DH and Y. The 21 clindamycin-resistant pediatric isolates were distributed among 9 REA groups (groups A, CF, DH, G, L, M, and Y and 2 unique nonspecific REA groups). These data suggest that a diverse array of relatively antibiotic-susceptible C. difficile strains predominate in a cohort of children with CDI compared to adults. T he increased frequency, morbidity, and mortality of Clostridium difficile infections (CDI) in adults over the past 2 decades are primarily attributable to the emergence and global spread of a fluoroquinolone-resistant strain known as BI/NAP1/027 (1, 2). CDI is now the most frequently encountered health care-associated infection in the United States (3), causing nearly 500,000 infections and 30,000 deaths each year (4). These troubling trends in the clinical and molecular epidemiology of CDI recently prompted the Centers for Disease Control and Prevention (CDC) to classify CDI among the most serious immediate antibiotic-resistant diseases representing "public health threats that require urgent and aggressive action" (5).The molecular epidemiology (6-8) and antibiotic resistance (7-9) patterns of CDI in adults over the past 3 decades have been well described. Although the prevalence of BI/NAP1/027 is declining, recent data from the United States (4) and the United Kingdom (10) indicate that BI/NAP1/027 is still an important cause of CDI in adults. Limited investigation of the molecular epidemiology of...

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“…Due to our inability to record symptoms, which could harm the sensitivity and specificity of our CDI episode or recurrence definitions, we were left to assume that if a patient had a positive laboratory test for the presence of toxigenic C difficile and CDI treatment was begun, the clinician appropriately diagnosed symptomatic CDI. Even with appropriate specimen collection, EIA and PCR-based toxigenic tests have suboptimal sensitivity and specificity [5, 16]. The EIA testing procedures are rapid, but have less sensitivity and specificity than the optimal, but rarely clinically available, stool culture.…”

Section: Discussionmentioning

confidence: 99%

A Propensity-Matched Analysis Between Standard Versus Tapered Oral Vancomycin Courses for the Management of Recurrent Clostridium difficile Infection

Gentry¹,

Giancola²,

Thind

et al. 2017

Open Forum Infectious Diseases

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BackgroundThis study was conducted to compare clinical outcomes of oral vancomycin courses without taper versus oral vancomycin courses with taper for treatment of recurrent Clostridium difficile infection (CDI).MethodsThis investigation was a multicenter, retrospective, propensity score-matched analysis study using a Veterans Health Administration national clinical administrative database. Adult patients who were treated for recurrent CDI from any Veterans Affairs Medical Center between June 1, 2011 and October 31, 2016 were included if they were treated with oral vancomycin with or without a tapering regimen. The 2 groups were matched by next-nearest approach from a propensity score formula derived from independent variables associated with the selection of a taper regimen.ResultsPropensity score matching resulted in 2 well-matched groups consisting of 226 episodes of patients treated with a vancomycin taper regimen and 678 episodes treated by vancomycin regimen without taper. No difference was found for the primary outcome of 180-day recurrence (59 of 226 [26.1%] for taper regimens versus 161 of 678 [23.8%], P = .48). A secondary outcome of 90-day all-cause mortality met statistical significance, favoring a taper regimen (5.31% vs 9.29%, P = .049); however, secondary outcomes of 90-day recurrence and 180-day all-cause mortality were not different.ConclusionsVancomycin taper regimens did not provide benefit over vancomycin regimens without taper in preventing additional CDI recurrence in patients with first or second recurrent episodes in this propensity score-matched analysis.

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Clinical Utility of Laboratory Detection of Clostridium difficile Strain BI/NAP1/027

Cited by 21 publications

References 34 publications

Ultrasensitive Detection of Clostridioides difficile Toxins A and B by Use of Automated Single-Molecule Counting Technology

Ultrasensitive Detection of Clostridioides difficile Toxins A and B by Use of Automated Single-Molecule Counting Technology

Differences in the Molecular Epidemiology and Antibiotic Susceptibility of Clostridium difficile Isolates in Pediatric and Adult Patients

A Propensity-Matched Analysis Between Standard Versus Tapered Oral Vancomycin Courses for the Management of Recurrent Clostridium difficile Infection

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