In Vitro Detection of MPXV DNA From Human Skin Lesion Specimens
Purpose
The ViroKey MPXV PCR Test is a real-time PCR test intended for the qualitative detection of DNA from monkeypox virus (MPXV) in human skin lesion material, including swabs of lesion exudate, roofs from more than one lesion, or lesion crusts.
Results are for the identification of MPXV and should be interpreted in conjunction with other clinical and laboratory findings. Positive results are indicative of the presence of MPXV DNA and negative results do not preclude the absence of MPXV DNA. Negative results must be combined with clinical observations, patient history, and epidemiological information.
For availability in your country, please contact your Freshstart Medical sales representative. Availability is subject to country’s regulatory approval.
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Ordering Information
ViroKey MPXV PCR Test
Item Number: 301124
Pack Size: 4×24
Zoonotic Diseases
Specifications
Regulatory Status
RUO
Workflow
Manual (Automated workflow available on-demand)
Sample Types
Human skin lesion specimens (including swabs of lesion exudate, lesion roofs or crusts)
Gene Targets
J2R & E9L
Limit of Detection
10 copies/reaction
Analytical Reactivity
Detects both Congo Basin and West African clades of MPXV*
* Tested with Twist Bioscience’s Synthetic human Monkeypox Virus (hMPXV) Controls
Turnaround Time
1.5 hours
Hands-On Time
0.5 hours
Controls
Positive Control (PC) or Negative Control (NC)
FEATURES AND BENEFITS
Open-channel capabilities
Walk-away automation
Supports different sample types
In-built thermomixer module that supports Sentosa SX Extraction kit
Preset run protocols for the Sentosa SX workflow
Color coding on tube holder to match reagent cap color to ensure correct positioning of reagents. Inscribed names provide further confirmation on the right placement
Small and compact footprint (W107;H67;D61 cm) (W42;H26;D24 in)
ID tracking functionality to ensure sample traceability
Primary tube handling
Barcoding of samples to reduce manual input error rates and saves time
Pre-scan with optical sensor before each run to ensure sufficient quantity and types of tips and labwares
Continuous audit trail with user specific digital signatures in compliance to CFR 21 Part 11
Connectivity to other instruments in workflow
Easy-to-clean, low maintenance & service requirement
Contact Us
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