INTENDED USE

This product is suitable for the qualitative detection of Monkeypox virus in nasopharyngeal swab, nasal swab, oropharyngeal swab, sputum or fecal samples. It provides an aid in the diagnosis of infection with Monkeypox virus.

SUMMARY

Monkeypox is a rare viral infectious disease similar to human smallpox caused by monkeypox virus, and it is also a zoonotic disease. Mainly found in the tropical rain forests of central and western Africa. The main route of transmission is animal-to-human transmission. People are infected with the disease by being bitten by infected animals or by direct contact with the blood and body fluids of infected animals.The Monkeypox virus is a high fatality rate virus,so the early screening test is very important to control the Monkeypox virus spread.

PRINCIPLE

The Monkeypox virus Antigen Detection Kit is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect Monkeypox virus. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibody against the Monkeypox virus; the reaction membrane contains the secondary antibodies for Monkeypox virus. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates absorbed in the reagent pad are dissolved and migrate along with the sample. If Monkeypox virus antigen is present in the sample, the complex of the anti-Monkeypox virus conjugate and the virus will be captured by the specific anti-Monkeypox virus monoclonal antibodies coated on the test line region (T). Absence of the T line suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking effect has occurred.