Cytomegalovirus (CMV), a member of the Herpesvirus family, is globally widespread and typically remains latent after primary infection. In immunocompromised patients, such as solid organ transplant recipients, CMV reactivation can lead to severe complications, including graft rejection and increased mortality. For this reason, accurate monitoring is essential for the clinical management of these patients.
This study evaluated the clinical performance of the new STAT-NAT® SN200 CMV kit, the first solution in the Sentinel Diagnostics virology panel to be compliant with the requirements of the IVDR regulation.
Clinical Performance Results
The results confirmed the high accuracy and reliability of the system across different biological matrices. The study demonstrated:
- Diagnostic Sensitivity and Specificity: higher than 95% for both plasma and whole blood, ensuring an excellent comparison with routine CE-marked assays.
- Predictive Values: the assay showed an extremely high Negative Predictive Value (NPV), reaching 100% for whole blood samples and 97.1% for plasma, making it a fundamental tool for confidently ruling out the presence of infection.
- Clinical Efficacy: the high positive Likelihood Ratio confirms the kit’s ability to correctly identify patients with active viral load.
- Analytical Validation: performance metrics for sensitivity (LoD), quantification (LoQ), and linearity were rigorously validated according to international CLSI standards.
Conclusion
The STAT-NAT® SN200 CMV kit, in combination with the SENTiNAT® 200 instrument, offers a comprehensive and automated solution for monitoring transplant patients. Together with the other tests in the Sentinel virology panel (which includes EBV, BKV, HAdV, HSV 1&2, HHV-6, HHV-7, HHV-8, Parvovirus, VZV, and JCV), it represents a robust and effective response for managing viral infections in immunocompromised patients, ensuring full compliance with the new IVDR regulatory standards.
Download the full poster presented at ESCMID 2026 here for technical details and performance charts
Click here to learn more about our solution for immunocompromised patients and our SENTiNAT 200 sample-to-result platform.