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.
SUMMAR
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
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
PERFORMANCE CHARACTERIST
1. Sensitivity, Specificity and Accuracy
The relative sensitivity and specificity of the Monkeypox Virus Antigen Rapid Test has been studied with the simulative positive cases and clincal negative cases. Below are the data we observed.
Method |
Gold standard reagent (PCR) |
Total Results |
Monkeypox Virus Antigen Rapid Test |
Results |
Positive |
Negative |
Positive |
10 |
0 |
10 |
Negative |
0 |
201 |
211 |
Total Result |
10 |
201 |
211 |
Relative Sensitivity: 100.00% (95%CI: 67.91%~100.00%)
Relative Specificity: 100.00% (95%CI:97.74%~100.00%)
Accuracy: 100.00% (95%CI:97.85%~100.00%)
COMPANY PROFILE
Hangzhou lmmuno Biotech Co., Ltd is the original organization in lmmuno Group, which has engaged in this industry for more than 10 years. The team of Hangzhou lmmuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage.In the past few years we focused on the human medical diagnostic field which mainly cover the following directions: rapid tests for vector-borne diseases(VBDs), rapid tests for sexually transmitted diseases (STDs), rapid tests for respiratory system diseases, rapid tests for digestive system diseases and rapid test for drug of abuse. For now, we are paying more attention to the diagnosis of neglected tropical diseases (NTDs). With strong R&D ability we are capable to develop and produce test kits for customers in a short time, and our product quality is ahead of similar products in the market.

