Ann Lab Med 2018; 38(5): 440-445  https://doi.org/10.3343/alm.2018.38.5.440
Evaluation of the Luminex ARIES HSV 1&2 Assay and Comparison with the FTD Neuro 9 and In-house Real-Time PCR Assays for Detecting Herpes Simplex Viruses
Chun Kiat Lee, M.S.1, Chean Nee Chai, M.S.1, Sharah Mae Capinpin, M.T.1, Alynn Ang, B.S.1, Sau Yoke Ng, B.S.1, Peak Ling Lee, B.S.1, Christopher Wai Siong Ng, B.S.1, Gabriel Yan, M.D.2, Hong Kai Lee, Ph.D.1, Lily-Lily Chiu, M.S.1, Roland Jureen, M.D.1, Benedict Yan, M.D.1, and Tze Ping Loh, M.D.1,3
Department of Laboratory Medicine1, National University Hospital, Singapore; Department of Medicine2, National University Health System, Singapore; Biomedical Institute for Global Health Research and Technology3, National University of Singapore, Singapore
Corresponding author: Chun Kiat Lee
https://orcid.org/0000-0002-6065-0000
Department of Laboratory Medicine, National University Health System 5 Lower Kent Ridge Road, Singapore 119074, Singapore
Tel: +65-6772-4175
Fax: +65-6772-4407
E-mail: chun_kiat_lee@nuhs.edu.sg
Received: November 17, 2017; Revised: December 15, 2017; Accepted: May 3, 2018; Published online: September 1, 2018.
© Korean Society for Laboratory Medicine. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: Human herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) are responsible for a plethora of human diseases, of which cutaneous and mucocutaneous infections are the most prevalent. In its most severe form, HSV infection can cause meningitis/encephalitis. We compared the Luminex ARIES HSV 1&2 assay (Luminex Corp., Austin, TX, USA), an automated sample-to-result molecular solution, to two non-automated HSV DNA assays.
Methods: A total of 116 artificial controls were used to determine the analytical performance of the ARIES assay. Controls were prepared by spiking universal transport medium (UTM) and cerebrospinal fluid (CSF) samples from patients who tested negative for HSV by an in-house HSV-1 and -2 DNA assay with reference materials (SeraCare Life Sciences, MA, USA; ZeptoMetrix Corp., MA, USA). Another 117 clinical samples were then used to compare the clinical performance of the ARIES assay with those of an in-house assay and the FTD Neuro 9 assay (Fast Track Diagnostics, Junglinster, Luxembourg).
Results: The analytical sensitivity (95% limit of detection) of the ARIES assay was 318 copies/mL (UTM samples) and 935 copies/mL (CSF samples) for HSV-1 strain 96 and 253 copies/mL (UTM samples) and 821 copies/mL (CSF samples) for HSV-2 strain 09. No cross-reactivity was observed in samples spiked with 14 non-HSV microorganisms. Compared with the reference result (agreement between the in-house and FTD Neuro 9 results), the ARIES assay had overall concordance rates of 98.2% (111/113) and 100% (113/113) for HSV-1 and HSV-2, respectively.
Conclusions: The ARIES assay appears to be an excellent alternative for rapid detection and differentiation of HSV in skin and genital infections, meningitis, and encephalitis.
Keywords: Herpes simplex virus, Genital infections, Skin infections, Luminex ARIES, Sample-to-result, Performance evaluation



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