Monkeypox Virus Nucleic Acid Detection Kit (Real-Time PCR Method) - CE Certified

FireGeneSKU: FG-MPVPCR-96

EU CE-Marked (IVD)

This product is an in vitro diagnostic kit used for the detection of Monkeypox Virus Nucleic Acids. The kit can be used to assess samples from skin swabs, papule or vesicle. The kit specifically amplify and detect the nucleic acid sequence of Monkeypox Virus, and there is no cross-reaction with other related viruses.

• This kit is available in the lyophilized format. It can be shipped and stored in room temperature.

• Contains a assay-in-tube master mix in the PCR tube for the detection of the MPV target and the internal positive control (IPC).

• The limit of detection of this kit is 125 copies /ml.

• No thawing of PCR components. Reconstituted reagents can be freezing-thawing for up to 5 times.

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Product Overview

Background Information

Monkeypox is a viral zoonosis caused by the monkeypox virus that can be transmitted between animals and humans and can also be retransmitted between humans. Based on the current epidemiological investigation, the incubation period is 6 to 13 days, mostly 5 to 21 days. The main symptoms are fever, severe headache, swollen lymph nodes, back pain, muscle aches and weakness. The rash usually begins 1-3 days after a fever and is concentrated on the face and limbs, Lesions can occur at anywhere from a few to thousands of sites, and in severe cases they can combine to cause large chunks of skin to fall off. These rashes are often very painful. When a rash appears, the patient is contagious. The nucleic acid of Monkeypox infections can be detected via real-time PCR in the specimen of blood and throat swabs, papule or vesicle. The current kit includes a set of specific primers and probes pre-mixed in the Master Mix of the kit targeting two specific gene regions of Monkeypox Virus. The first gene is the orthopoxvirus DNA polymerase gene (E9L) for the detection of Eurasian orthopoxviruses other than variola viruses, and the second one is a viral envelope protein gene (B6R), which specifically detects monkeypox virus (MPXV). A set of primers and probes against human RNase P gene is also included as internal control (IC) for sample collection, processing, and detection.

Detection Principle

The detection of nucleic acid of Monkeypox Virus is based on quantitative real-time
PCR technology.In RT-PCR reaction, the forward and reverse primers bind to the specific regions of selected genes and amplify the regions (amplicons); the probes specifically bind to target sequence of the amplicons. Specific primers and probes are designed on the specific gene areas of Monkeypox Virus. Probes consist of a reporter fluorophore at 5' and quenching fluorophore at 3'. The fluorescent signals emitted from reporter fluorophores are absorbed by the quenchers, so it doesn’t emit signals. During amplification, probes bound to templates are cut off by Taq enzyme with 5'-3' exonuclease activity, separating reporter dye from the quencher, generating fluorescent signals, the PCR instrument will then automatically draw a real-time amplification curve based on the signal change, realizing the qualitative detection of Monkeypox Virus at the nucleic acid level.

Specifications

Product Type Molecular Detection
Applications RT-PCR, MPV Nucleic Acids Detection
Compatible Sample Types Blood, skin and throat swabs, papule or vesicle, etc.
Target The orthopoxvirus DNA polymerase gene (E9L) and the viral envelope protein gene (B6R)
Method Real-time fluorescent PCR
Prep Time Results in 2 hours.
Analysis sensitivity > 125 copies/ml
Supported Instruments Ardent GS-PCR3200; ABI7500, ABI Quant Studio models 3/5/6/7/12K; Roche Lightcycler®480/1536/Nano; Agilent Mx3000P/3005P; Qiagen Rotor-Gene 6000/Q; Bio-Rad CFX384/CFX96, Bio-Rad Touch/iQ5; Cepheid Smart-cycler/Smart Cycler II; Eppendorf
Master Cycler.
Storage Room temp (lyophilized)
Shelf-life 12 months

 

Note: please login/signup to download and view the user manual for all specifications and protocol.

Kit Components


24 Tests/Kit 48 Tests/Kit 96 Tests/Kit Main Compositions
Master Mix (Lyophilized) 3 8-tube strips 6 8-tube strips 12 8-tube strips Tris-HCL; Primers; Probes; Enzyme mix including UDG; Taq polymerase; dNTPs; RNasin
Solvent 400 μL 800 μL 1600 μL Tris-HCL; Glycerin; KCL; MgCl2
Positive Control 40 μL 40 μL 40 μL Synthetic DNA Fragments; Tris-EDTA buffer
Nuclease-free Water 0.5mL 0.5mL 0.5mL Nuclease-free Water

 

Restrictions

  1. For In Vitro Diagnostic use only in EU regions.
  2. Research Use Only in the United States.

Files Available (Login to View/Download)

- CE-IVD Marking Certification Letter
- EU Declaration of Conformity
- User Manual

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