What is Monkeypox?
Monkeypox is a rare disease caused by infection with the Monkeypox virus which is part of the same family of viruses as smallpox.

How is Monkeypox Transmitted?
1. The virus transmitted from animal to human is by direct contact with the blood, bodily fluids, or cutaneous or mucosal lesions of infected animals.
2. From human to human is by close contact with respiratory secretions, skin lesions of an infected person or recently contaminated objects.
3. Most reported cases so far have been identified through sexual health or other health services in primary or secondary healthcare facilities and have involved mainly men who have sex with men.

Symptoms of Monkeypox can include:
Is it Important to Have Monkeypox Testing?
Early detection and early diagnosis are crucial for taking measures and then curbing the Monkeypox outbreak. As a leading in vitro diagnostic products manufacturer with 20 years of experience, Singclean has rapidly developed Monkeypox Virus Test Kit Series to help with the massive testing.

Singclean® Monkeypox Virus Antigen Test Kit

Intended Use
Monkeypox virus Antigen Test Kit (Immunochromatography) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigens to the Monkeypox virus in nasal swabs, skin lesions specimens, serum, or plasma specimens. This test provides only a preliminary test result. Therefore, any reactive specimen with the Monkeypox virus Antigen Test Kit (Immunochromatography) must be confirmed with alternative testing method(s) and clinical findings.
 

Product Features
Specifications
 

Materials Provided
*Materials Required but Not Provided
1. Timer
2. Specimen collection container
3. Sterile needle
4. Pipette
5. Centrifuge
6. Disposable latex gloves

Sample Collection
Test Procedure

For Nasal Swab or Skin Lesions Specimens


Interpretation of Results
*Positive:
In addition to the presence of C band, if T band is developed, the test indicates for the presence of Monkeypox virus antigen in the specimen. The result is Monkeypox virus positive.
*Negative:
If only the C band is present, the absence of any burgundy color in the T band indicates that no Monkeypox virus antigen is detected in the specimen. The result is negative.
*Invalid:
The control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

*Precautions
·For laboratory professional use.
·All specimens should be considered potentially hazardous and handled in the same way as an infectious material.
·Read the entire procedure carefully prior to performing any tests.
·The used testing materials should be discarded in accordance with local, state, and/or federal regulations.

*Limitations
1. Use fresh samples whenever possible.
2. Optimal assay performance requires strict adherence to the assay procedure described in this insert sheet. Deviations may lead to aberrant results.
3. A negative result for an individual subject indicates the absence of detectable Monkeypox virus antigen. However, a negative test result does not preclude the possibility of exposure to or infection with the Monkeypox virus.
4. A negative result can occur if the quantity of the Monkeypox virus antigen present in the specimen is below the detection limits of the assay or failed to collect the Monkeypox virus antigen in specimens.
5. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
6. Recent or remote vaccination with a vaccinia-based vaccine (e.g. anyone vaccinated before smallpox eradication, or more recently vaccinated due to higher risk such as orthopoxvirus laboratory personnel) might lead to false positive results.