Monkeypox Virus IgM/IgG Ab Rapid Test
Product Background
Monkeypox is used to be a viral zoonosis with symptoms very similar to those in smallpox patients, caused by by infection with Monkeypox virus. It is an enveloped double-stranded DNA virus that belongs to the Orthopoxvirus genus of the Poxviridae family. Human monkeypox was fifirst identifified in humans in 1970 in the Democratic Republic of the Congo in a 9-year-old boy in a region where smallpox had been eliminated in 1968. Since then, most cases have been reported from rural, rainforest regions of the Congo Basin, particularly in the Democratic Republic of the Congo and human cases have increasingly been reported from across Central and West Africa. In humans, the symptoms of monkeypox are similar to but milder than the symptoms of smallpox. Monkeypox begins with fever, headache, muscle aches, and exhaustion. The main difffference between symptoms of smallpox and monkeypox is that monkeypox causes lymph nodes to swell (lymphadenopathy) while smallpox does not. The incubation period (time from infection tosymptoms) for monkeypox is usually 7−14 days but can range from 5−21 days.
Intended use
The product is a lateral flflow chromatographic immunoassay for the qualitative detection of monkeypox virus IgM/IgG antibody in human whole blood, serum or plasma. It is indicated for use as an aid in the diagnosis and
monitoring of Monkeypox Virus infection.
Operation steps and result interpretatio
IgM Positive: The control line and IgM line (M) are visible in the result window. The test is positive for IgM antibodies.
lgG Positive: The control line and IgG line (G) are visible in the result window. The test is positive for IgG antibodies.
IgM and lgG Positive: The control line, IgM line(M) and IgG line (M) lines are visible in the result window. The test is positive for IgM and IgG antibodies.
Negative: The control line is the only line visible in the result window. No IgG or IgM antibodies have been detected.
Invalid: If the control line does not appear in the result window,the test results are INVALID regardless of the presence or absence of the test line.
NOTE: Insuffiffifficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the
procedure and repeat the test with a new cassette. If problem persists, please contact your local distributor.