FireGene announces that its Monkeypox Virus Nucleic Acid Detection Kit (Real-time Fluorescent PCR Method) has recently obtained CE-IVDD approval. This RT-PCT kit can be used to detect suspected cases of MPV infection. Rash fluid, nasopharyngeal swabs, pharyngeal swabs, and serum samples are applicable for the test. The test result is available in 40 minutes after sample collection. This kit is available for diagnostic use in EU regions and research use in the United States.
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 (MPV). 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.
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.
In response to the 2022 monkeypox outbreak, we have developed our Lyophilized Monkeypox Virus Real-Time PCR Kit and obtained CE-IVD approval. The lyophilized kit includes a set of specific primers and probes pre-mixed in the Master Mix targeting two specific gene regions of Monkeypox Virus (MPV). 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). This Lyophilized Monkeypox Virus Real-Time PCR Kit is specifically designed for easy operation without the need for cold chain transportation and storage.
The FireGene's Lyophilized Monkeypox Virus Real-Time PCR Kit is approved for diagnostics purposes in countries that accept CE-marked IVD tests:
- Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
Note: The kit is available for diagnostic use in all countries that accept the EU CE-IVD Mark. This MPV RT-PCR Kit is still available for research use in the U.S. and other countries.
The MPV Nucleic Acid Detection Kit is ready to ship in small and bulk quantities to meet the immediate demand for monkeypox virus testing. This lyophilized MPV RT-PCR Kit can be shipped and stored at room temperature. With the pre-assembled one-step mix bead in the PCR tube, the assay will be ready by simply adding reconstitution buffer to the PCR tube. This kit is also compatible with most RT-PCR instruments (refer to product page for the full list of supported instruments). We are committed to supplying the Monkeypox Virus RT-PCR Detection Kit at an affordable price to help all countries to contain the spread of Monkeypox Virus.