Freeze-dried Monkeypox Virus Nucleic Acid Detection Kit (fluorescence PCR method)

【Intended Use】

This kit is used for in vitro qualitative detection of monkeypox virus DNA in swab samples of lesional rashes, pustular surfaces or exudates of patients suspected of monkeypox infection and other patients who need to be diagnosed or differentially diagnosed with monkeypox virus infection. It should not be used as the sole basis for patient management decisions.

【Detection Principle】

This kit is designed with specific primers and probes for the Monkeypox Virus F3L Gene, and uses real-time fluorescent polymerase chain reaction (qPCR) and fluorescent Taqman® probe technology to amplify and detect specific genes of the monkeypox virus. It also monitors the entire process of sampling, extraction, and detection of the sample to be tested through human internal standards to avoid false negative results. 

The kit is a fully premixed lyophilized system that contains the nucleic acid amplification enzyme, UDG enzyme, reaction buffer, and specific primers and probes required for monkeypox virus detection. After adding the reconstitution solution and the extracted sample nucleic acid, it can be directly tested.

【Advantages】

• With BTK-8 PCR Analyzer, up to 30min. to complete detection.(Can be adapted to various internationally used PCR analyzers).

• Minimum limitation of detection: 200 copies/mL.

• Contains UDG enzyme, effectively avoiding false positive results caused by nucleic acid amplification.

• Human conserved genes are used as internal standard monitoring to avoid false negative results in the entire process from sampling, nucleic acid extraction to detection and analysis.

• The operation is simple. The enzymes, primer probes, and reaction buffers required for the detection process have been freeze-dried in the detection system, and no manual liquid preparation and packaging operations are required.

【Package Specification】

Note:

1. Components of different batches cannot be mixed.

2. Please prepare your own sampling kit and nucleic acid extraction or purification reagents. The recommended extraction reagent is the nucleic acid extraction reagent of Wuxi Bioteke Biotechnology Co., Ltd. (Article No.: AU52111, Registration No.: Suxi Xiebei 20190105).

3. Use the same batch of reagent kits to perform negative control and positive control tests at least once a day to ensure that the environment is pollution-free and the reagents and instruments are effective.

4. The "Monkeypox Virus Freeze-dried Reagent" must be used on the machine within 2 hours after reconstitution. The "Monkeypox Virus Freeze-dried Reagent" that has not been used up after opening can be sealed and stored at -20±5℃. If the freeze-dried powder leaks or deliquesces, do not continue to use it.

【Storage Conditions and Shelf Life】

The test kit can be transported at room temperature within 1 month.

The test kit is valid for 12 months when stored at -20±5℃, and no more than 6 months when temporarily stored at 2~8℃, 

No more than 7 times of repeated freezing and thawing.

The temperature during transportation must not exceed 37°C.

【Product qualifications】