Clostridium difficile Toxin A/B ELISA Kit (DEIA05711)

Regulatory status: For research use only, not for use in diagnostic procedures.

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Species Reactivity
Intended Use
The Clostridium difficile Toxin A/B test is an enzyme immunoassay for the qualitative determination of Toxins A and B of Clostridium difficile in stool samples and from cultures of Clostridium difficile toxin-producing strains previously cultured from stool samples.
Contents of Kit
1. Microwell plate: 1 x 96 wells
2. Sample-dilution buffer: 1 x 100 mL
3. Wash buffer(10x): 1 x 100 mL
4. Control: 1 x 1.8 mL
5. Conjugate 1: 1 x 10 mL
6. Conjugate 2: 1 x 10 mL
7. Substrate: 1 x 10 mL
8. Stop reagent: 1 x 6 mL
All reagents must be stored at 2-8°C and can be used until the expiration date printed on the product label. For more detailed information, please download the following document on our website.


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Workflow optimization for syndromic diarrhea diagnosis using the molecular Seegene Allplex (TM) GI-Bacteria(I) assay


Authors: Zimmermann, Stefan; Horner, Susanne; Altwegg, Martin; Dalpke, Alexander H.

Syndromic panel-based molecular testing has been suggested to improve and accelerate microbiological diagnosis. We aimed to analyze workflow improvements when using the multiplex Seegene Allplex (TM) GI-Bacteria(I) assay as a first-line assay for bacterial diarrhea. Technical assay evaluation was done using spiked stool samples and stored patient samples. After implementation of the assay in the routine clinical workflow, an analysis of 5032 clinical samples analyzed by the Seegene assay and 4173 control samples examined by culture in a similar time period 1 year earlier was performed. Sensitivity of the assay was shown to be between 0.4 and 95.9 genome equivalents/PCR. For 159 positive patient samples with a composite reference of culture and/or a molecular assay, the sensitivity of the assay was 100% for Campylobacter, 92% for Salmonella, 89% for Aeromonas, and 83% for Shigella. Sensitivity for C. difficile toxin B detection was 93.9%. The comparison of clinical samples obtained in two 8-month periods showed increased detection rates for Aeromonas (2.90%vs. 0.34%), Campylobacter spp. (2.25% vs. 1.34%), Shigella spp. (0.42% vs. 0.05%) whereas detection of Salmonella was slightly decreased (0.46% vs. 0.67%) when using the Seegene assay. An analysis of the time-to-result showed that the median dropped from 52.7 to 26.4 h when using the molecular panel testing. The Seegene Allplex (TM) GI-Bacteria(I) assay allows accelerated, reliable detection of major gastrointestinal bacteria roughly within 1 day. Workload is reduced, specifically in a low-prevalence setting.

Evaluation of Cycle Threshold, Toxin Concentration, and Clinical Characteristics of Clostridioides difficile Infection in Patients with Discordant Diagnostic Test Results


Authors: Shah, Megan D.; Balada-Llasat, Joan-Miquel; Coe, Kelci; Reed, Erica; Sandlund, Johanna; Pancholi, Preeti

Clostridioides difficile infection (CDI) is one of the most common health care-associated infections that can cause significant morbidity and mortality. CDI diagnosis involves laboratory testing in conjunction with clinical assessment. The objective of this study was to assess the performance of various C. difficile tests and to compare clinical characteristics, Xpert C. difficile/Epi (PCR) cycle threshold (C-T), and Singulex Clarity C. diff toxins A/B (Clarity) concentrations between groups with discordant test results. Unformed stool specimens from 200 hospitalized adults (100 PCR positive and 100 negative) were tested by cell cytotoxicity neutralization assay (CCNA), C. diff Quik Chek Complete (Quik Chek), Premier Toxins A and B, and Clarity. Clinical data, including CDI severity and CDI risk factors, were compared between discordant test results. Compared to CCNA, PCR had the highest sensitivity at 100% and Quik Chek had the highest specificity at 100%. Among clinical and laboratory data studied, prevalences of leukocytosis, prior antibiotic use, and hospitalizations were consistently higher across all subgroups in comparisons of toxin-positive to toxin- negative patients. Among PCR-positive samples, the median C-T was lower in toxin-positive samples than in toxin-negative samples; however, C-T ranges overlapped. Among Clarity-positive samples, the quantitative toxin concentration was significantly higher in toxin-positive samples than in toxin-negative samples as determined by CCNA and Quik Chek Toxin A and B. Laboratory tests for CDI vary in sensitivity and specificity. The quantitative toxin concentration may offer value in guiding CDI diagnosis and treatment. The presence of leukocytosis, prior antibiotic use, and previous hospitalizations may assist with CDI diagnosis, while other clinical parameters may not be consistently reliable.

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