ViroKey MPXV PCR Test

In Vitro Detection of MPXV DNA From Human Skin Lesion Specimens

PURPOSE

ViroKey MPXV PCR Test

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.

FEATURES AND BENEFITS

Reliable Detection

  • Sensitive and robust, specific to both West African and Congo Basin clades
  • Specific to monkeypox viruses with no cross-reactivity to other orthopoxviruses (smallpox, horsepox, vaccinia, cowpox, rabbitpox, camelpox)

Maximizing Laboratory Efficiency

  • No requirement for batching
  • Results within 3.5 hours after extraction
  • Automated workflow available on-demand

Compatible with Various RT-PCR Instruments

  • Applied Biosystems 7500 Fast Real-Time PCR System

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 Target J2R
Limit of Detection 10 copies/reaction
Analytical Reactivity Detects both Congo Basin and West African clades of MPXV*
Analytical Specificity No cross reactivity with other orthopoxviruses
Turnaround Time 1.5 hours
Hands-On Time 0.5 hours
Controls Positive Control (PC) or Negative Control (NC)

 

* Tested with Twist Bioscience's Synthetic human Monkeypox Virus (hMPXV) Controls

PRODUCT FLYERS

ViroKey MPXV PCR Test Flyer RUO EN

ORDERING INFORMATION

ProductPack SizeItem Number
ViroKey MPXV PCR Test 4x24 301124

For availability in your country, please contact your Vela Diagnostics sales representative. Availability is subject to country's regulatory approval.

For more product related documents, please contact us

DOWNLOADS



Product Info
ViroKey MPXV PCR Test Flyer V1.0