Ann Lab Med.  2018 Sep;38(5):440-445. 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

• Lee CK
• Chai CN
• Capinpin S
• Ang A
• Ng SY
• Lee PL
• Ng CW
• Yan G
• Lee HK
• Chiu LL
• Jureen R
• Yan B
• Loh TP

• KMID: 2434733
• DOI: http://doi.org/10.3343/alm.2018.38.5.440

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.

Keyword

Herpes simplex virus; Genital infections; Skin infections; Luminex ARIES; Sample-to-result; Performance evaluation

MeSH Terms

Biological Science Disciplines
Cerebrospinal Fluid
DNA
Encephalitis
Herpes Simplex*
Herpesvirus 1, Human
Herpesvirus 2, Human
Humans
Meningitis
Real-Time Polymerase Chain Reaction*
Simplexvirus*
Skin
DNA

Figure

• 

  Fig. 1 Luminex ARIES HSV 1&2 assay limit of detection (LoD). (A) The LoD of the ARIES assay for detecting herpes simplex virus type 1 (HSV-1) strain type 96 in artificial universal transport medium (UTM) controls. (B) The LoD of the ARIES assay for detecting HSV-1 strain type 96 in artificial cerebrospinal fluid (CSF) controls. (C) The LoD of the ARIES assay for detecting herpes simplex virus type 2 (HSV-2) strain type 09 in artificial UTM controls. (D) The LoD of the ARIES assay for detecting HSV-2 strain type 09 in artificial CSF controls.

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