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The Solana HSV 1+2/VZV Assay is a multiplex in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2), and Varicella-zoster virus (VZV) nucleic acids isolated and purified from cutaneous or mucocutaneous swab specimens obtained from symptomatic patients.

The Solana HSV 1+2/VZV Assay consists of two major steps: (1) specimen preparation, and (2) amplification and detection of target sequence specific to HSV-1, HSV-2 and/or VZV using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe.

Using HDA technology the target sequences are amplified by HSV-1, HSV-2 and/or VZV specific primers and detected by HSV-1, HSV-2 and/or VZV specific fluorescence probes included in the Reaction Tube. A competitive process control (PRC) is included in the Process Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by specific primers and detected by a PRC specific fluorescence probe.

Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s five USB ports. Solana HSV 1+2/VZV is also supported by the power of Virena®.

Features & Benefits

FeatureBenefit
HDA technology

Rapid method of nucleic acid amplification that does not require thermal cycler

Lyophilized Master Mix reagent

Easy-to-use format, just add processed sample to rehydrate

Small, easy-to-use instrument

Eliminates the need for dedicated molecular space and costly capital equipment, allowing for testing in smaller labs

CLIA moderately complex

Requires minimal training

Refrigerated storage

No freezer needed, 2˚C to 8˚C storage

Long shelf life

Currently 12 months from date of manufacture

Room temperature at set up

No ice or cooling block required

Product Specifications

Product Spec NameProduct Spec Data
Sample type

Cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus type 1, herpes simplex virus type 2 and/or varicella-zoster infection.

Time to results

Approximately 50 minutes

Reagent storage conditions

Process Buffer and Reaction Tubes; 2˚C to 8˚C

Control storage conditions

2˚C to 8˚C

Sample preparation storage conditions (cultured enriched broth)

Room temperature (up to 30 °C) for up to 48 hours, 2° to 8°C or –20°C for up to 7 days prior to processing.

Sensitivity

Cutaneous: HSV-1 100.0%, HSV-2 92.3%, VZV 100%; Mucocutaneous: HSV-1 100%, HSV-2 99.1%, VZV 100.0%; Non categorized HSV-1 100%, HSV-2 100%, VZV 100.0%

Specificity

Cutaneous: HSV-1 98.0%, HSV-2 94.4%, VZV 96.5%; Mucocutaneous: HSV-1 96.4%, HSV-2 97.2%, VZV 98.6%; Non categorized HSV-1 97.9%, HSV-2 96.6%, VZV 94.1%

Ordering Information

Catalog NumberDescription
M302

Solana HSV 1+2/VZV Assay Kit

M118

Solana HSV 1+2/VZV Control Set

Product Documentation