Multicenter clinical evaluation of a fully automated multiplex HSV-1, HSV-2, and VZV real-time PCR assay.

Authors

Joseph Yao, Erin McElvania, Mohammad Al-Ghoul, Parul Patel, Rupinder Kular, Jeffrey Wuitschick, Shihai Huang, John Birdsall, Ekaterina Pestova, Neelam Dhiman

Published in

Journal of clinical microbiology. Pages e0053526. Aug 14, 2026. Epub Aug 14, 2026.

Abstract

Herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), and varicella-zoster virus (VZV) are associated with a range of clinical manifestations depending on the anatomical site of infection. HSV and VZV lesions often exhibit similar phenotypical characteristics, making clinical differentiation challenging. Detection and differentiation of HSV-1, HSV-2, and VZV are essential for diagnosis and treatment management. An automated multiplex real-time PCR assay, Alinity m HSV 1 & 2/VZV assay, was developed to detect and differentiate HSV-1, HSV-2, and VZV. The assay was validated for use with cutaneous and mucocutaneous lesion swab specimens collected in commercial viral transport media from symptomatic patients. The assay demonstrated a limit of detection of 5.90 TCID₅₀/mL for HSV-1, 2.07 TCID₅₀/mL for HSV-2, and 0.055 TCID₅₀/mL for VZV. Testing with clinical swab specimens demonstrated greater than 95% clinical sensitivity and specificity for all three analytes. The Alinity m HSV 1 & 2/VZV assay provides a reliable and accurate method for detection and differentiation of HSV-1, HSV-2, and VZV in lesion swab specimens for improved diagnostic accuracy and patient management.IMPORTANCEHerpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), and varicella-zoster virus (VZV) can cause skin and mucocutaneous lesions that often appear clinically similar, making accurate diagnosis difficult without laboratory testing. Rapid and reliable identification of the causative virus is important because patient counseling, treatment decisions, and infection management differ among these infections. In this multicenter study, a fully automated molecular assay was evaluated that simultaneously detects and differentiates HSV-1, HSV-2, and VZV from a single-lesion swab specimen. Testing of more than 1,200 clinical specimens demonstrated high sensitivity and specificity for all three viruses. The assay also offers a streamlined workflow with minimal hands-on time and rapid turnaround. These findings support the use of this multiplex assay as a practical diagnostic tool that can improve laboratory efficiency and provide clinicians with timely, accurate results to guide patient care.

PMID:
42599190
Bibliographic data and abstract were imported from PubMed on 14 Aug 2026.

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