Simplexa® VZV Swab Direct Kit
The first and only FDA Cleared stand-alone molecular assay for VZV
Direct detection of varicella-zoster virus DNA in cutaneous and mucocutaneous lesion swab specimens.
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Disease state
Varicella-zoster virus (VZV) infections cause primary (chickenpox) or secondary infection (shingles)1. VZV is highly contagious, spread by exposure to individuals shedding the virus by person-to-person contact, vesicular fluid aerosol inhalation from skin lesions, and aerosolized respiratory secretions.
Complications of VZV infection include bacterial skin infections, adult pneumonia, and in children, soft tissue infections. Severe complications include:
- Encephalitis.
- VZV infection of internal organs.
- Postherpetic neuralgia in immunocompromised individuals.
- VZV can complicate pregnancy; newborns of infected mothers may develop congenital varicella syndrome or neonatal varicella.
VZV is a leading cause of adult encephalitis, second only to HSV. Approximately 90 percent of the population will be infected by age 15 and are at risk for developing encephalitis caused by VZV.
Varicella-zoster virus infection causes two clinically distinct forms of disease depending on whether an individual is experiencing a primary (chickenpox) or secondary infection (shingles)
The value of Simplexa® VZV Swab Direct Kit
Fast and accurate detection of VZV with the seamless flexibility for differential diagnosis with HSV 1&2
Proven VZV testing efficiencies
One test for a wide range of mucocutaneous and cutaneous lesions of VZV with only 50µl of unextracted sample input and uncompromised performance in 60 minutes.
Delivers diagnostic confidence and testing flexibility
Greater than 97% clinical sensitivity and 99% specificity.
The ability to run separately or alongside the Simplexa® HSV 1 & 2 Direct and the Simplexa® VZV Direct (CSF) on the same disc at the same time.
How the Simplexa® VZV Swab Kit works
Simplexa® VZV Swab Direct is an in-vitro qualitative real-time PCR assay with a simple workflow, enabling unextracted primary sample and ready-to-use PCR reagent loading on a re-usable Direct Amplification Disc on the compact LIAISON® MDX system designed for operational simplicity, flexibility, and quality assurance for utility across any clinical lab —qualitative detection of varicella-zoster virus (VZV) DNA from patients with signs and symptoms of VZV infection.
Sample-to-answer
Scan 1-8 primary unextracted samples per run, ready-to-use single-use reaction mix vials, and the 8-well Direct Amplification Disc. Simply load samples and reagents directly onto the disc, place the disc on the LIAISON® MDX Instrument and press run for results in 60 minutes.
Intiutive LIAISON® MDX Studio Software
Integrated QC checks and reporting for individual assays or use the multi-assay suite feature for compatible assays - Simplexa® VZV Direct is compatible with the Simplexa® VZV Swab and HSV 1&2 Direct assays in the same run: view PCR curves and QC Charts, interface with LIS and even during run access software.
Most comprehensive sample types covered
Cutaneous and mucocutaneous lesion swabs can be collected from locations including anorectal, genital, nasal, ocular, oral, urethra, skin, and others.
Simplexa® VZV Direct Swab workflow
Scan, load and go
Ready to use
- No prep & No waste
- Single use reagents (24 reactions)
- No mixing, pouring or rehydrating
Simple & easy workflow
- No extraction needed, direct sample input
- Liquid sensor to ensure adequate sample volume metered: No precise pipetting required
- CLIA Moderate Complexity
Scanning
- Scan the assay definition QR code (upon first use only)
- Scan the lot-specific QR code on a vial or card
- Scan the disc barcode
- Scan the sample barcode
Loading
In each Disc Wedge:
- Load 50 µl of sample
- Load 50 µl of reaction mix (= 1 vial content)
- Close the foil and remove the tab
- Disc may be re-used up to 8 times (until all Wedges are utilized)
- Close the foil and remove the tab
Load and run
Load the disc onto the LIAISON® MDX and start the run. The results and a final report are automatically generated by the software.
To be used on the LIAISON® MDX Instrument
The LIAISON® MDX is an innovative and powerful real-time PCR instrument with two consumable disc options: the 8-well Direct Amplification Disc and the 96-well Universal Disc for higher volume testing.
Supported by an expanding menu of molecular assays, the system provides easy-to-understand results with the ability to check amplification curves after a run. All of this in a compact footprint measuring only 12″ by 8″ by 12″ so that it can fit into laboratories of any size.
Simplexa® VZV Swab Direct ordering info
Part Name |
Kit Size |
Registration Status |
Part Number |
|---|---|---|---|
|
Simplexa® VZV Swab Direct Kit |
24 |
IVD | MOL3655 |
|
Simplexa® VZV Positive Control Pack |
10 |
- | MOL3660 |