INTENDED USE

This kit uses immunochromatography technology to qualitatively detect monkeypox virus antigen in human lesion exudate, scab or oropharyngeal swab samples. It is suitable for the early aid of monkeypox virus infection diagnosis and screening.

PRINCIPAL

The test kit is a qualitative membrane strip based immunoassay for the detection of monkeypox virus antigen in human lesion exudate, scab or oropharyngeal swab samples. In this test procedure, monkeypox virus antibody is immobilized in the test line region of the test card. After a lesion exudate or scab sample is placed in the sample well, it reacts with monkeypox virus antibody coated particles that have been applied to the sample pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized monkeypox virus antibody. If the sample contains monkeypox virus antigen, a colored line will appear in the test line region indicating a positive result. If the sample does not contain monkeypox virus antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of sample has been added and membrane wicking has occurred.

Storage and Stability

•Store the test kit between 4°C~30°C in a place out of direct sunlight, product expiration date 24 months.
•After the foil pouch is opened, the test card should be used as soon as possible within 1 hour.

Precautions

•This kit is a disposable in vitro diagnostic reagent, please do not reuse, and do not use expired products.
•The aluminum foil pouch contains a desiccant and should not be taken internally.
•Fresh samples are recommended.
•Components in different lot kits should not be cross-used to avoid erroneous results.
•The temperature of the experimental environment should be avoided from being too high, and the test card should be restored to room temperature before opening it to avoid moisture absorption.
•After the test, the used test card, sample diluent etc. will be disposed of as biomedical waste.
•Please pay attention to safety measures during operation, such as wearing protective clothing and gloves.
•As with all diagnostic reagents, the final diagnosis should be made by the physician after taking into account the various test indicators and clinical symptoms.