ArticleJournal of clinical microbiology2015
Development and Validation of Digital Enzyme-Linked Immunosorbent Assays for Ultrasensitive Detection and Quantification of Clostridium difficile Toxins in Stool.
Article in Journal of clinical microbiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 58 citations in OpenAlex.
- Development of Peptide Glucosyltransferase Inhibitors With Comprehensive Coverage Across Clostridioides difficile Toxin B Sub-Types.Biotechnology and bioengineering · 2026Article
- Determination of the performance of a novel diagnostic test forJournal of clinical microbiology · 2025Article
- Emerging Diagnostics inInternational journal of molecular sciences · 2024Review
- Clostridioides (Clostridium) difficile: A silent nosocomial pathogen.Saudi medical journal · 2023Review
- Design of 8-mer peptides that block Clostridioides difficile toxin A in intestinal cells.Communications biology · 2023Article
- A leaky human colon model reveals uncoupled apical/basal cytotoxicity in earlyAmerican journal of physiology. Gastrointestinal and liver physiology · 2023Article
- Preservation of the Innate Immune Response toOpen forum infectious diseases · 2023Article
- Design of 8-mer Peptides that BlockbioRxiv : the preprint server for biology · 2023Article
- Ultrasensitive and Quantitative Toxin Measurement Correlates With Baseline Severity, Severe Outcomes, and Recurrence Among Hospitalized Patients With Clostridioides difficile Infection.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Article
- Rapid Quantification ofAnalytical chemistry · 2022Article
- Article
- Rapid-format recombinant antibody-based methods for the diagnosis ofFrontiers in microbiology · 2022Review
- Alzheimer's Disease Biomarkers Revisited From the Amyloid Cascade Hypothesis Standpoint.Frontiers in neuroscience · 2022Review
- Absence of Toxemia in Clostridioides difficile Infection: Results from Ultrasensitive Toxin Assay of Serum.Digestive diseases and sciences · 2021Article
- Humoral Immune Response toOpen forum infectious diseases · 2021Article
- Ulcerative colitis-related severe enteritis: an infrequent but serious complication after colectomy.Journal of gastroenterology · 2021Article
- Neurofilament Light Chain and Intermediate HTT Alleles as Combined Biomarkers in Italian ALS Patients.Frontiers in neuroscience · 2021Article
- Toxin A-Predominant Pathogenic Clostridioides difficile: A Novel Clinical Phenotype.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020Article
- Ultrasensitive Clostridioides difficile Toxin Testing for Higher Diagnostic Accuracy.Journal of clinical microbiology · 2020Review
- Prospective Evaluation of the mariPOC Test for Detection of Clostridioides difficile Glutamate Dehydrogenase and Toxins A/B.Journal of clinical microbiology · 2020Article
Corrections and comments
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Authors and funding
13 authors at 5 institutions in 1 country.
Funding
Abstract
The currently available diagnostics for Clostridium difficile infection (CDI) have major limitations. Despite mounting evidence that toxin detection is paramount for diagnosis, conventional toxin immunoassays are insufficiently sensitive and cytotoxicity assays too complex; assays that detect toxigenic organisms (toxigenic culture [TC] and nucleic acid amplification testing [NAAT]) are confounded by asymptomatic colonization by toxigenic C. difficile. We developed ultrasensitive digital enzyme-linked immunosorbent assays (ELISAs) for toxins A and B using single-molecule array technology and validated the assays using (i) culture filtrates from a panel of clinical C. difficile isolates and (ii) 149 adult stool specimens already tested routinely by NAAT. The digital ELISAs detected toxins A and B in stool with limits of detection of 0.45 and 1.5 pg/ml, respectively, quantified toxins across a 4-log range, and detected toxins from all clinical strains studied. Using specimens that were negative by cytotoxicity assay/TC/NAAT, clinical cutoffs were set at 29.4 pg/ml (toxin A) and 23.3 pg/ml (toxin B); the resulting clinical specificities were 96% and 98%, respectively. The toxin B digital ELISA was 100% sensitive versus cytotoxicity assay. Twenty-five percent and 22% of the samples positive by NAAT and TC, respectively, were negative by the toxin B digital ELISA, consistent with the presence of organism but minimal or no toxin. The mean toxin levels by digital ELISA were 1.5- to 1.7-fold higher in five patients with CDI-attributable severe outcomes, versus 68 patients without, but this difference was not statistically significant. Ultrasensitive digital ELISAs for the detection and quantification of toxins A and B in stool can provide a rapid and simple tool for the diagnosis of CDI with both high analytical sensitivity and high clinical specificity.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.