Overview
Monitoring viral pathogens like Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), and BK Virus (BKV) is critical for the management of solid organ and hematopoietic stem cell transplant recipients. This study, conducted in collaboration with the IRCCS Sant’Orsola Polyclinic, evaluates the clinical and analytical performance of the STAT-NAT® SN200 kits on the fully automated SENTiNAT® 200 platform.
Key Features of the STAT-NAT® SN200 Kits
- Sample-to-Result Automation: Fully integrated workflow encompassing extraction, setup, and PCR amplification.
- Multi-Matrix Validation: Validated for high-precision testing in plasma, whole blood, and urine.
- Regulatory Compliance: The STAT-NAT® SN200 CMV assay is the first in the line to be IVDR compliant.
- Comprehensive Panel: Part of a wide virology range including Adenovirus, HSV 1&2, HHV-6, HHV-7, HHV-8, Parvovirus, VZV, and JCV.
Clinical & Analytical Performance
The retrospective study compared the STAT-NAT® SN200 assays against routine CE/IVD methods (ELITechGroup), demonstrating excellent correlation and reliability.
Analytical Highlights:
- Sensitivity (LOD): Ranges from as low as 4.80E+01 IU/mL (EBV Plasma) to 1.61E+02 IU/mL (CMV Plasma).
- Linearity: Broad dynamic ranges, reaching up to 1.00E+08 IU/mL for CMV and EBV.
Diagnostic Performance Summary:
- Diagnostic Sensitivity: > 95% across all tested matrices (Plasma, Whole Blood, Urine).
- Diagnostic Specificity: > 95% compared to routine laboratory testing.
- Accuracy: High specificity and sensitivity values were confirmed for CMV (up to 99.2% specificity in plasma), EBV (up to 100% sensitivity in plasma), and BKV (up to 99% sensitivity in urine).
Conclusion:
The SENTiNAT® 200 platform combined with STAT-NAT® SN200 kits provides a sensitive, precise, and reproducible solution for infection management in immunocompromised patients, ensuring standardized and efficient laboratory workflows.