Simplexa™ VZV Direct
Only targeted FDA cleared in vitro qualitative PCR assay for the direct detection of VZV from CSF samples
Accurate and rapid targeted diagnosis of VZV in CSF Samples with seamless compatibility with Simplexa™ HSV 1 & 2 Direct for effective diagnosis of viral meningitis/encephalitis.
Powered by Bioz
Disease state
Varicella-zoster virus (VZV) infections cause primary (chickenpox) or secondary infection (shingles). 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 is a highly contagious pathogen associated with chickenpox, shingles, and a multitude of secondary infections, including encephalitis
The value of Simplexa™ VZV Direct
The only targeted FDA cleared PCR assay for diagnosing VZV CNS infections
Fast molecular workflow for CSF samples
CLIA moderate complexity assay provides results in approximately one hour - no DNA extraction is required.
Operational efficiencies with minimum CSF sample input
Uncompromised performance from 50μL of CSF sample ideal for pediatric and adult testing.
Delivering diagnostic confidence
100% Positive Percent Agreement (clinical sensitivity)
99% Negative Percent Agreement (clinical specificity) in prospective studies
How Simplexa™
VZV Direct works
Simplexa™ VZV 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 in cerebrospinal fluid (CSF) from patients with signs and symptoms of meningitis, encephalitis, or both.
Sample-to-answer workflow with timely results
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.
Intuitive 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 direct compatible with the Simplexa™ VZV Swab Direct and HSV 1 & 2 Direct assays in the same run. View PCR curves and QC Charts, interface with LIS and even access software during the run.
Simplexa™ VZV Direct 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
Scan
- 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
Load
In each Disc wedge:
- Load 50 µl of sample
- Load 50 µl of reaction mix
- Close the foil and remove the tab
Run
- Load the disc onto the LIAISON® MDX and start the run. The results and a final report are automatically generated by the software.
- Close the foil and remove the tab Disc may be re-used up to 8 times (until all Wedges are utilized)
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 Direct ordering info
Part Name |
Kit Size |
Registration Status |
Part Number |
|---|---|---|---|
|
Simplexa™ VZV Direct Kit |
24 |
IVD | MOL3650 |
|
Simplexa™ VZV Positive Control Pack |
10 |
IVD | MOL3660 |