Monkeypox Virus MPXV IgG/IgM Antibody Rapid Test Kit In Human Serum Plasma Or

INTENDED USE

The Monkeypox Virus IgG/IgM Antibody Rapid Test Kit is a rapid, qualitative and convenient immunochromatographic in vitro assay for the differential detection of IgM & IgG antibodies to Monkeypox Virus (MPXV) in human serum, plasma or whole blood samples aid in the diagnosis of Monkeypox Virus infection. Monkeypox is a zoonotic orthopoxvirus that incidentally causes disease in humans similar to smallpox. Transmission can occur through contact with bodily fluids, skin lesions, or respiratory droplets of infected animals directly or indirectly via contaminated fomites. Following viral entry from any route (oropharynx, nasopharynx, or intradermal), the monkeypox virus replicates at the inoculation site then spreads to local lymph nodes. Next, an initial viremia leads to viral spread and seeding of other organs. This represents the incubation period and typically lasts 7 to 14 days with an upper limit of 21 days.

PRINCIPLE

This kit is based on the principle of colloidal gold immunochromatography for the qualitative detection of MPXV antibodies in human serum, plasma or whole blood samples. The colloidal gold-labeled recombinant MPXV antigen and rabbit IgG colloidal gold marker were coated on a gold label pad, and the mouse anti-human IgM monoclonal antibody and mouse anti-human IgG monoclonal antibody were coated on the detection line (T line) position on the nitrocellulose membrane. The control line (C line) was coated with goat anti-rabbit IgG polyclonal antibody. When an appropriate amount of sample to be tested is added to the sample well of the test cassette, the sample will move forward under the action of chromatography. If the sample contains a novel coronavirus antibody, the antibody can bind to a colloidal gold-labeled recombinant new coronavirus antigen to form an immune complex. The immune complex will continue to undergo The inside of the nitrocellulose membrane flows forward. When the immune complex passes the T line, it binds to the coated the mouse anti-human IgM monoclonal antibody and mouse anti-human IgG monoclonal antibody to form a complex and agglutinates. The free colloidal gold marker and Goat anti-rabbit IgG polyclonal antibody coated at the line binds and develops color. Negative samples develop color only at

Technical Parameters:

COMPONENTS

Component of the test strip in the cassette:

Sample pad: contains buffered salts and detergents.

Label pad: contains gold-labeled recombinant MPXV antigen and rabbit IgG.

Nitrocellulose membrane:

Control line: contains Goat anti- rabbit IgG polyclonal antibody and buffer.

Test line: contains mouse anti-human IgM monoclonal antibody and mouse anti-human IgG monoclonal antibody and buffer.

Absorbent pad: made of highly absorbent paper

MATERIALS SUPPLIE

Cassettes ●Sample buffer ●Pipette droppers ●Lancets ●Alcohol swab ●Instructions For Use

MATERIAL REQUIRED BUT NOT PROVIDED

● Clock or Timer ● Specimen collection containers

WARNINGS AND PRECAUTIONS

1. This product is a single-use in vitro diagnostic reagent. Do not reuse it. Do not use it if it is expired.

2. Each component of the kit cannot be used in batches.

3. The positive result obtained by using this kit needs further confirmation by other methods.

4. The temperature of the experimental environment should be avoided. The reaction temperature should be 10~30℃, and the reaction humidity should be less than 60%. The test cassette stored at low temperature should be equilibrated to room temperature before opening to avoid moisture absorption.

5. The intensity of the color of the test line is not necessarily related to the titer of the antibody in the sample, and the result interpreted after 15 minutes is invalid.

6. The components of the kit and the waste produced by the test are treated as infectious pollutants.

7. For clinical reference only, and cannot be used as a basis for confirming or excluding cases alone.