Intended use

The kit is intended to be used for the in vitro qualitative detection of nucleic acid of monkeypox virus in human serum, lesion exudate, oropharyngeal swabs, or nasopharyngeal swab specimens by real-time PCR method.

For professional use only.Neither for self-testing of untrained individuals, nor near-patient testing.

Summary

Monkeypox virus is an orthopoxvirus that causes an infectious disease with symptoms include fever, severe headache, swollen lymph nodes, muscle aches and backache,Chills,exhaustion,rashes. Swollen lymph nodes are a characteristic feature of monkeypox. The monkeypox virus can be transmitted to both humans and animals through an infected animal bite, direct contact with infected bodily fluids, or prolonged close contact ,usually among family members. It is dangerous for children, immunocompromised people ,pregnant women,who are more likely to develop severe disease than adults. Infections during pregnancy can also lead to complications that affect fetal development,WHO reported . The genome is not segmented and contains a single molecule of linear double-stranded DNA, 185000-nucleotide long.The Monkeypox virus can be detected by realtime polymerase chain reaction(RT-PCR).

PRODUCT PARAMETER

PRODUCT PARAMETER
Method	Real-time PCR	Instrument	Real-time PCR analyzer containing fluorescence channels of FAM, HEX/VIC
Reagent	Liquid	Reaction Time	45min
Detection	Monkeypox virus	Interpretation	Negative: IC ＞ 38 or undetermined, Ct > 37 or undetermined Positive :IC ≤ 38,Ct ≤ 37
Sample	Serum, lesion exudate and respiratory tract samples	Certificate	CE