Immunity test kit

for antigensmonkeypoxclinical

The Monkeypox Virus Ag Test Kit is a gold immuno-chromatographic assay (GICA) that is intended for the qualitative detection of the nucleocapsid protein Antigen from Monkeypox Virus in oropharyngeal swaband saliva specimens directly from individuals who are suspected of Monkeypox Virus by their healthcare provider, with or without signs and symptoms of Monkeypox Virus. Results are for the identification of Monkeypox Virus nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine 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 should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out Monkeypox Virus and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with Monkeypox Virus. The Monkeypox Virus Ag Test Kit is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. Storage and Expiry Date 2. The Test Cassette should be used within 2 hour once it has been removed from the foil pouch.