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Multicenter Evaluation of the Simplexa VZV Direct Assay for Detection of Varicella-Zoster Virus in Cerebrospinal Fluid and Lesion-Swab Specimens. J Clin Microbiol 2022 Apr 20;60(4):e0235521

Date

03/15/2022

Pubmed ID

35285727

Pubmed Central ID

PMC9020333

DOI

10.1128/jcm.02355-21

Scopus ID

2-s2.0-85128801876 (requires institutional sign-in at Scopus site)   1 Citation

Abstract

Varicella-zoster virus (VZV) is the etiologic agent of varicella (chickenpox) and herpes zoster (shingles) infections commonly involving skin, mucous membranes, and less frequently the central nervous system. Traditional methods for the laboratory diagnosis of these infections are time-consuming, labor-intensive, and often insensitive. As such, these tests are being replaced by more sensitive and rapid molecular methods. This study evaluated the performance of two different molecular assays, the Simplexa VZV Direct and Simplexa VZV Swab Direct, to detect VZV DNA in cerebrospinal fluid (CSF) and lesion-swab specimens, respectively. The Simplexa VZV Direct and Simplexa VZV Swab Direct assays were compared against individual composite reference methods that varied depending on the sample cohort examined. A total of 883 CSF and 452 cutaneous and mucocutaneous prospective, retrospective, and contrived specimens were evaluated in this multicenter study. The results of this study showed that the Simplexa assays demonstrated near perfect agreement (k = 0.98) compared to the composite reference methods for the detection of VZV in CSF and lesion swab specimens. A further comparison between the standard of care molecular assays employed at the site of specimen collection and the Simplexa assays demonstrated excellent agreement (k = 1.0). The Simplexa assays offer rapid and reliable alternatives for the detection of VZV in certain clinical specimens without the need for nucleic acid extraction.

Author List

Pancholi P, Relich RF, Chandrasekaran S, Dunn JJ, Granato PA, Harrington AT, Hansen GT, Ledeboer NA, Li Q, Sims MD, Uphoff TS, Greene W, Young S, Dhiman N

Author

Nathan A. Ledeboer PhD Vice Chair, Professor in the Pathology department at Medical College of Wisconsin




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

Chickenpox
Herpes Zoster
Herpesvirus 3, Human
Humans
Prospective Studies
Retrospective Studies
Specimen Handling