Evaluation of the clinical performance of Vivalytic for detecting C. difficile
Background
Clostridioides difficile (C. difficile) is a significant cause of healthcare-associated infections, leading to conditions ranging from mild diarrhea to severe colitis.
Accurate and timely diagnosis of C. difficile infection (CDI) is critical for patient management and infection control. Traditional diagnostic methods face challenges, including delayed results and the need for specialized laboratory facilities. Point-of-care (POC) assays offer a promising alternative, potentially enabling rapid and accurate diagnosis.
We evaluated the clinical performance of a new molecular POC assay, Vivalytic C. difficile.
Methods
124 liquid or soft human stool samples from two study sites were analyzed. At MVZ Labor Dr. Limbach & Kollegen GbR in Heidelberg, Germany, 44 samples (21 positive and 23 negative) were tested.
At aprimeo diagnostics GmbH in Pfungstadt, Germany, 80 samples (39 positive and 41 negative) were tested. A total of 122 valid samples were included in the analysis.
The RIDA®GENE Clostridium difficile assay was used as reference method (R-Biopharm AG). Discrepant results were resolved with Allplex™ GI-Bacteria(I) assay (Seegene) and Xpert® C. difficile BT assay (Cepheid).
The Vivalytic C. difficile test combines rapid and precise testing at the point of care.
- Time to result: Early finish 35 min; max. 50 min
- Hands on time: 2 min
- Fully automated
Results
The Vivalytic C. difficile assay showed 12 initial discrepant results compared to the reference tests. Upon retesting these samples with the reference methods, 5 discrepancies remained: 3 false positives and 2 false negatives.
The assay demonstrated a Positive Percent Agreement (PPA) of 96.61 % and a Negative Percent Agreement (NPA) of 95.24 %.
Conclusion
The Vivalytic C. difficile assay exhibits high sensitivity and specificity, making it a viable option for rapid diagnosis of C. difficile infection.
Its implementation could enhance clinical decision-making and infection control practices by providing timely results without the need for specialized laboratory infrastructure.
