Monkeypox Virus Detection Kit (F-PCR)

INTENDED USE
Monkeypox Virus Detection Kit (F-PCR)  is a lateral flow immunoassay for the qualitative detection of monkeypox virus antigen in human serum, plasma or whole blood samples or rash exudate. It is intended to be used as a screening test and provides a preliminary test result for early diagnosis and management of patients related to infection with Monkeypox.
Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be combined to confirm the test result obtained by this device.

Summary and explanation
Monkeypox is a viral zoonotic disease with symptoms in humans similar to those seen in the past in smallpox patients. Monkeypox occurs in monkeys in the rain forests of central and western Africa, and can also infect other animals and occasionally humans. The clinical manifestations are similar to those of smallpox, but the disease is milder. The virus can be transmitted from animals to humans through direct close contact, and it can also spread from person to person. The main routes of infection include blood and body fluids. However, monkeypox is far less contagious than the smallpox virus.
Monkeypox Virus Antigen Detection Kit (Colloidal Gold) is an immunological diagnostic test used for detection of monkeypox virus Antigen based on the colloidal gold-immunochromatography assay. This method is rapid and convenient to use and requires few equipment. It can be performed within 15-20 minutes by minimally skilled personnel.

TEST PROCEDURE
This kit adopts colloidal gold-immunochromatography assay (GICA).
The test card contains:
1. Colloidal gold-labeled antibody and quality control antibody complex.
2. Nitrocellulose membranes immobilized with one test line (T line) and one quality control line (C line).
When an appropriate amount of sample is added to the sample well of the test card, the sample will move forward along the test card under capillary action.
If the sample contains an antigen of Monkeypox Virus, the antigen will bind to the colloidal gold-labeled Monkeypox Virus antibody, and the immune complex will be captured by the monoclonal anti-human IgM antibody immobilized on the nitrocellulose membrane to form a purple/red T line, showing that the sample is positive for IgM antibody.

Materials Provided

Certification