HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST
Easy preanalytical treatment
One of the standout features of the VirClia® Monotest is its sophisticated preanalytical for the stool sample preparation, facilitated by a unique filtering device that avoids the need of sample centrifugation. Unlike other ELISA or CLIA methods that require labour-intensive centrifugation, the VirClia® assay employs a smart filtering device with the pre-filled sample tubes, streamlining the preanalytical process and enhancing the overall efficiency and reliability of the diagnostic procedure.
Evolving landscape of Helicobacter pylori diagnosis
Helicobacter pylori infection is a significant global health issue, linked to chronic gastritis, peptic ulcers, and gastric cancer, affecting about half of the population, especially in developing countries. Accurate and timely diagnosis is crucial, and recent advancements in in vitro diagnostics (IVD) have made stool antigen testing a key non-invasive method for detecting H. pylori.
Spotlight on the new VirClia® Monotest
Vircell has developed an innovative, fully automated monotest CLIA solution for detecting H. pylori antigen in stool samples. This monotest includes all reagents and controls in the strip, enabling on-demand testing and allowing integration with over 90 parameters in the VirClia® Lotus system.
Publications and Media
> Poster SEIMC
In this study, 313 samples were evaluated for Helicobacter pylori antigen detection, comparing the VirClia®, Liaison®, and SD Biosensor assays. The VIRCLIA® MONOTEST demonstrated excellent performance, with over 94% agreement with both assays. It showed the best balance between sensitivity (91%) and specificity (98%) compared to a consensus result, highlighting its high accuracy and reliability for detecting H. pylori.
> ESCMID talk: VirClia® Monotest: new paradigm for Helicobacter pylori stool antigen testing
> Tech Note: VirClia® Helicobacter pylori Ag comparison vs reference methods
The HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST demonstrated strong performance metrics when compared to other established assays. Compared to one reference assay, it showed a relative sensitivity of 86%, relative specificity of 98%, and an agreement rate of 94.6%. When compared to another reference assay in the market, it had a relative sensitivity of 89%, relative specificity of 98%, and an agreement rate of 95.4%.
Technical Specifications
Sandwich chemiluminescent immunoassay (CLIA) for the detection of Helicobacter pylori antigen in human stool samples.
- Flexible and fully automated solution.
- Fast and easy pre-analytical treatment, without centrifugation.
- Simple protocol with results in 1 hour.
- Method based upon antigen capture using monoclonal antibodies.
- Individual quality control per monotest, no need for additional controls or calibrations.
- Objective method with excellent diagnostic sensitivity and specificity.
Ordering information
Other resources
Promotional video- VirClia® H. Pylori, meet the fully automated solution for stool antigen detection!
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