Clinical validation of the Lyra direct HSV 1+2/VZV assay for simultaneous detection and differentiation of three herpesviruses in cutaneous and mucocutaneous lesions

Feinan Fan; Jeffrey Stiles; Albina Mikhlina; Xuedong Lu; N Esther Babady; Yi-Wei Tang

doi:10.1128/JCM.02098-14

Clinical validation of the Lyra direct HSV 1+2/VZV assay for simultaneous detection and differentiation of three herpesviruses in cutaneous and mucocutaneous lesions

J Clin Microbiol. 2014 Oct;52(10):3799-801. doi: 10.1128/JCM.02098-14. Epub 2014 Jul 30.

Authors

Feinan Fan¹, Jeffrey Stiles², Albina Mikhlina², Xuedong Lu³, N Esther Babady², Yi-Wei Tang⁴

Affiliations

¹ Department of Laboratory Medicine, Futian Hospital, Guangdong Medical College, Shenzhen, China Department of Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
² Department of Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
³ Department of Laboratory Medicine, Futian Hospital, Guangdong Medical College, Shenzhen, China.
⁴ Department of Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA Department of Pathology and Laboratory Medicine, Weill Medical College of Cornell University, New York, New York, USA [email protected].

Abstract

We evaluated the Lyra Direct HSV 1+2/VZV multiplex real-time PCR assay for the detection and differentiation of herpes simplex virus 1 (HSV-1), HSV-2, and varicella-zoster virus (VZV) on 695 consecutive cutaneous and mucocutaneous lesion specimens. The intra-assay and interassay coefficient of variation values for the Lyra assay were 0.29 to 1.30% and 2.33 to 2.61%, respectively. The sensitivities, specificities, and positive and negative predictive values were 93.4 to 95.0%, 96.1 to 96.8%, 78.0 to 80.3%, and 99.0 to 99.1%, respectively, in comparison to those of viral culture. The values were further improved when a resolution analysis was performed with a laboratory-developed PCR assay.

Publication types

Research Support, Non-U.S. Gov't
Validation Study

MeSH terms

Adult
Aged
Female
Herpesviridae Infections / diagnosis*
Herpesviridae Infections / virology
Herpesvirus 1, Human / classification
Herpesvirus 1, Human / genetics
Herpesvirus 1, Human / isolation & purification*
Herpesvirus 2, Human / classification
Herpesvirus 2, Human / genetics
Herpesvirus 2, Human / isolation & purification*
Humans
Male
Middle Aged
Molecular Diagnostic Techniques / methods*
Mucous Membrane / virology*
Multiplex Polymerase Chain Reaction / methods
Prospective Studies
Real-Time Polymerase Chain Reaction / methods
Reproducibility of Results
Sensitivity and Specificity
Skin / virology*
Varicellovirus / classification
Varicellovirus / genetics
Varicellovirus / isolation & purification*