INTENDED USE
The Monkeypox Virus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Monkeypox antigen in human skin lesion swab, or mucous membrane swab specimen in individuals who are suspected of monkeypox-like symptoms or recent contact with monkeypox infected patients.
INTRODUCTION
Monkeypox is used to be a viral zoonosis with symptoms very similar to those in smallpox patients, caused by by infection with Monkeypox virus. It is an enveloped double-stranded DNA virus that belongs to the Orthopoxvirus genus of the Poxviridae family. Human monkeypox was first identified in humans in 1970 in the Democratic Republic of the Congo. Recently in 2022, the monkeypox virus is spreading across the world, with reports of cases in the U.K., Spain, Portugal, the U.S and some more countries. In humans, the symptoms of monkeypox are similar to but milder than the symptoms of smallpox. Monkeypox begins with fever, headache, muscle aches, and exhaustion. The incubation period (time from infection to symptoms) for monkeypox is usually 7−14 days but can range from 5−21 days. The virus enters the body through broken skin (even if not visible), respiratory tract, or the mucous membranes (eyes, nose, or mouth). Animal-to-human transmission may occur by bite or scratch, bush meat preparation, direct contact with body fluids or lesion material, or indirect contact with lesion material, such as through contaminated bedding. Human-to-human transmission is thought to occur primarily through large respiratory droplets. Respiratory droplets generally cannot travel more than a few feet, so prolonged face-to-face contact is required. Other human-to-human methods of transmission include direct contact with body fluids or lesion material, and indirect contact with lesion material, such as through contaminated clothing or linens.
The Monkeypox Virus Antigen Rapid Test is designed as a simple tool in detection of Monkeypox for regular clinical diagnosis.
MATERIALS
Materials Prov
Materials
Materials Provided
- Foil pouches, each contains one test cassette, and one disposable dropper with desiccant bags
- Assay buffer tubes (0.8ml each)
- Disposable sampling swabs
- Paper tube holder
- Instruction for use
Materials Required But Not Provided
- Timer
Materials Required but Not provided
TEST PROCEDURE
Allow the rapid test, specimen, buffer, and/or controls to equilibrate to room temperature (15 - 30°C) prior to testing.
- Bring the pouch to room temperature before opening. Remove the rapid test cassette from the sealed pouch and use it as soon as possible.
- Place the test device on a clean and horizontal surface. Suck the treated sample extraction from the assay buffer tube and place 3 drops into the specimen well (S) of the test cassette. Start the timer.
- Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.
INTERPRETATION OF RESULTS
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