FastPlex Monkeypox Real-time PCR Detection Kit

Monkeypox virus (MPXV) is an endemic zoonotic orthopoxvirus (OPX) found in West and Central Africa. The majority of human monkeypox (MPX) infections are reported from the Congo Basin in the Democratic Republic of Congo (DRC). MPXV is transmitted to humans from a primary zoonotic source, and it is also capable of human-to-human transmission. While the animal reservoir of MPXV remains unknown, several genera of African rodents (Cricetomys, Graphiurus, Funiscirurus) have been identified as potential reservoirs responsible for the transmission and maintenance of the virus. Contact with wildlife, often occurring in rural communities in the DRC that rely on bushmeat as a protein source, is believed to increase the risk of human infection with MPXV.

The FastPlex Monkeypox Real-time PCR Detection Kit is designed for the qualitative detection of Monkeypox virus (MPXV) DNA in serum or lesion exudate samples. It utilizes real-time polymerase chain reaction (RT-PCR) combined with Taqman fluorescent probe technology for the qualitative detection of Monkeypox virus DNA. The MPXV F3L gene DNA detection probes are fluorescently labeled with FAM, the MPXV B6R gene DNA detection probes are fluorescently labeled with HEX, and the internal control detection probe is fluorescently labeled with Cy5.

Positive results indicate the presence of MPXV DNA; however, clinical correlation with patient history and other diagnostic information is necessary to determine the patient's infection status. Positive results do not exclude the possibility of bacterial infection or co-infection with other viruses. The detected agent may not be the definitive cause of the disease. Negative results do not rule out MPXV virus infection and should not be the sole basis for patient management decisions. They must be interpreted in conjunction with clinical observations, patient history, and epidemiological information.

The FastPlex Monkeypox Real-time PCR Detection Kit is intended for use by trained clinical laboratory personnel who are specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

Features of the RainSure FastPlex Monkeypox Real-time PCR Detection Kit include:

1. Fast detection: The kit can provide results within 1 hour using the fast amplification mode of the newly launched Fast-16 portable real-time PCR platform. It has high specificity and sensitivity, allowing for the detection of low concentrations of the virus in samples.

2. Wide coverage: The detection range of the kit encompasses both the West African branch and the Central African (Congo Basin) branch of MPXV.

3. Convenient transportation: The kit offers two forms of reagent (lyophilized and liquid). The lyophilized powder can be stored at room temperature for an extended period, facilitating long-distance transportation and effectively reducing reagent transportation costs.

4. Fully compatible with any real-time PCR equipment.

5. Large volume loading: Up to 23 μL.

6. Multigene detection: F3L gene (FAM), B6R gene (HEX), and internal reference gene (Cy5).

7. Sample detection limit: 500 copies/ml (real-time PCR)