REF:

C2301 (Cassette)

INTENDED USE:

Monkeypox Virus Antigen Test Kit is an immunochromatographic assay that use double-antibody sandwich method for qualitative detection of monkeypox virus antigens in human serum, plasma, whole blood, nasopharyngeal swab, lesion exudate and saliva specimens. It is used to aid in the diagnosis of monkeypox virus infection. This device performed manually. The test kit cannot be used as the sole basis for treatment or other management decision. Performance of the test is limited to professional use. The test can be applied to any potential monkeypox virus infection patients.

For in vitro diagnostic use only.

SUMMARY:

The monkeypox virus is a zoonotic disease caused by an orthopoxvirus, and results in a smallpox-like disease in humans. Human monkeypox is primarily endemic in central and western Africa but has recently emerged in the United States. Early symptoms of monkeypox virus infection include fever, headache, muscle pains, fatigue, and swollen glands. After a few days of early symptoms, patients may develop a few to thousands of characteristic lesions on the face, hands, and feet. MPV transmission may occurs through exposure to patients’ saliva/respiratory excretion or exposure to lesion exudates or crusting material. There are currently three detection methods for monkeypox infection: polymerase chain reaction (PCR) tests, Antigen-based and serological test kits. Monkeypox Virus Antigen Test Kit is a rapid test and can give results in 15 mins without any instruments.