【Intended Use】
The Monkeypox Virus Detection Kit (Fluorescence PCR) is a qualitative in vitro real-time PCR test for the detection of nucleic acid from monkeypox virus in oropharyngeal swab, nasopharyngeal swab, serum, plasma and human pustular or vesicular rash specimens from individuals suspected of monkeypox virus infectious. Results are for the identification of monkeypox virus DNA. Positive results are indicative of the presence of monkeypox virus DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude monkeypox virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The Monkeypox Virus Detection Kit (Fluorescence PCR) is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
【Detection Principle】
Monkeypox virus (MPV) is the virus that causes the disease monkeypox in both humans and animals. Monkeypox virus is an Orthopoxvirus, a genus of the family Poxviridae that contains other viral species that target mammals. This test is a qualitative real-time fluorescent PCR enables to amplification of monkeypox virus. Primers and sequence-specific fluorescence probes were designed tailored to detect the highly specific regions of the F3L gene and B7R gene of monkeypox virus. A pair of primers and a probe for detecting endogenous human RNase P gene are included as an internal control to monitor the whole test process and control for inhibition. The probes were attached by fluorophores at the 5’end as a reporter with FAM for the F3L gene and B7R gene, and the specific probe of RNase P is labeled with VIC. The virus DNA in the sample should be purified and enriched with a nucleic acid extraction and purification reagent before detected with this kit.