title: Clinical validation of the Lyra direct HSV 1+2/VZV assay for simultaneous detection and differentiation of three herpesviruses in cutaneous and mucocutaneous lesions.
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.
authors: 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.
authors: Feinan
authors: F
authors: Fan
authors: Department of Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
authors: Jeffrey
authors: J
authors: Stiles
authors: Department of Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
authors: Albina
authors: A
authors: Mikhlina
authors: Department of Laboratory Medicine, Futian Hospital, Guangdong Medical College, Shenzhen, China.
authors: Xuedong
authors: X
authors: Lu
authors: Department of Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
authors: N Esther
authors: NE
authors: Babady
authors: 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 tangy@mskcc.org.
authors: Yi-Wei
authors: YW
authors: Tang
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006566:Herpesviridae Infections / Q000175:diagnosis* / Q000821:virology; D018259:Herpesvirus 1, Human / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D018258:Herpesvirus 2, Human / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009092:Mucous Membrane / Q000821:virology*; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods; D011446:Prospective Studies; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012867:Skin / Q000821:virology*; D018140:Varicellovirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*