Faculty Collaboration Database

Validation of the Clinical Performance and Reproducibility of the Savanna HSV 1+2/VZV Assay. J Mol Diagn 2025 Jul;27(7):605-614

Date

04/26/2025

Pubmed ID

40280407

DOI

10.1016/j.jmoldx.2025.03.009

Scopus ID

2-s2.0-105005959969 (requires institutional sign-in at Scopus site)

Abstract

Herpes simplex virus 1 (HSV-1), HSV 2 (HSV-2), and varicella-zoster virus (VZV) cause nondescript cutaneous and mucocutaneous lesions requiring rapid, differential identification for appropriate diagnosis and patient counseling. Decentralized multiplex molecular assays may provide more rapid results than existing methodologies but require clinical validation. This multicenter study evaluated the clinical performance of the Savanna HSV 1+2/VZV Assay against the high-complexity Lyra Direct HSV 1+2/VZV real-time PCR nucleic acid test for the detection of HSV-1, HSV-2, and VZV from clinical specimens. The Savanna HSV 1+2/VZV Assay is an automated, moderate-complexity, real-time PCR assay recently cleared by the US Food and Drug Administration for the simultaneous detection and differentiation of HSV-1, HSV-2, and VZV DNA isolated from lesion swabs. In this study, 744 clinical specimens (531 female, 213 male) were evaluated by Savanna and compared with Lyra. Discrepant result analysis was conducted with the moderate-complexity Solana HSV 1+2/VZV isothermal nucleic acid test. For 744 clinical samples, Savanna exhibited overall, positive, and negative percent agreement of 99.5%, 100%, and 99.3% for HSV-1; 99.9%, 100%, and 99.8% for HSV-2; and 100%, 100%, and 100% for VZV. The Savanna HSV 1+2/VZV Assay exhibited excellent performance in a multicenter, clinical study. Savanna can provide laboratory-equivalent results outside of the central laboratory with the potential to deliver accurate results during the patient visit.

Author List

Faron ML, Caldwell JM, Sabharwal L, Purpora A, Meece J, Bhattarai P, O'Neill J, Christian M, Dhiman NX, Halliday J, Hoff JS, Vause CV, Granato PA

Author

Jessica Hoff PhD Assistant Professor in the Pathology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adolescent
Adult
Aged
Child
DNA, Viral
Female
Herpes Simplex
Herpesvirus 1, Human
Herpesvirus 2, Human
Herpesvirus 3, Human
Humans
Male
Middle Aged
Molecular Diagnostic Techniques
Real-Time Polymerase Chain Reaction
Reproducibility of Results
Sensitivity and Specificity
Young Adult