INTENDED USE
The Ebola Antigen Rapid Test is an in vitro diagnostic single-use immunoassay for the qualitative detection of antigens from viruses within the Ebola virus genus but does not differentiate between these viruses. lt is designed for qualitative determination of Ebola antigen in Human whole blood,serum or plasma as an aid in the diagnosis of Ebola infection.

SUMMARY AND EXPLANATION THE TEST
Ebola hemorrhagic fever is a severe, often-fatal disease in humans and nonhuman primates that has appeared sporadically since its initial recognition in 1976. Ebola virus is one of three genera of the family of RNA viruses called the Filoviridae. There are four species of Ebola virus affecting humans: Bundibugyo virus (BDBV), Sudan virus (SUDV), Tai Forest virus (TAFV), and Ebola virus (EBOV) strains. The presence of Ebola virus antigens indicate that the individual may be currently infected and capable oftransmitting the virus.
Ebola antigens are captured and visualized by colloidal gold labeled with Ebola antibodies generating a visible line in the test zone for a positive sample.

PRINCIPLE
This kit uses the double – antibody sandwich method of immunochromatography to detect the Ebola virus antigen in samples. It generates a test line in the membrane test line area, enabling rapid qualitative detection of the Ebola virus antigen.
During the testing process, when the sample is added to the sample – loading well, if the sample contains the Ebola virus antigen and its content is not lower than the minimum detection limit of this product, it will first bind to the colloidal gold – Ebola virus monoclonal antibody 1 complex on the glass fiber membrane. When this complex flows to the test line, it binds to the Ebola virus monoclonal antibody 2 fixed on the test line and forms an immune complex with the colloidal gold label, causing a red line to appear on the T line, indicating a positive result. If the Ebola virus antigen is absent in the sample or its content is lower than the minimum detection limit of this product, no red line will form on the test line (T line), indicating a negative result. The quality control product (C) is coated with sheep anti – mouse IgG polyclonal antibody, and a line should appear on the quality control line (C line) to prove that the kit is working properly.