Monkeypox Virus Antibody Test Kit (Colloidal Gold)

INTENDED USE
Babio® Monkeypox Virus Antibody Test Kit (Colloidal Gold) is intended for qualitative detection of antibodies to monkeypox virus antibody in whole blood, serum and plasma samples. It is intended for use in medical institutions by trained staff as an aid for the diagnosis of clinical conditions related to infection with monkeypox virus.

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 Antibody Test Kit (Colloidal Gold) is an immunological diagnostic test  used for detection of monkeypox virus antibody  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 Principle
The Monkeypox Virus Antibody Test Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay.
The test cassette consists of: 
1) a red colored conjugate pad containing recombinant Monkeypox Virus antigens conjugated with colloidal gold  and a control antibody conjugated with colloidal gold；
2)a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with non-conjugated recombinant Monkeypox Virus antigens, and the C line is pre-coated with a control line antibody.
When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. Anti- Monkeypox Virus antibody, if present in the specimen, will bind to the Monkeypox Virus conjugates. The immunocomplex is then captured on the membrane by the pre-coated Monkeypox Virus antigen forming a red colored T line, indicating a Monkeypox Virus antibody positive test result. Absence of the T line suggests a negative result.
The test contains an internal control (C line) which should exhibit a red colored line regardless of color development on the T line. If the C line does not exhibit, the test result is invalid, and the specimen must be retested with another device. 

Reagents And Materials Supplied

Interpretation Of The Result

Positive：a red line appears at the position of the quality control line (C line) and the detection line (T line) , which indicates the test result of monkeypox virus antibody in the sample was positive.
Negative: If only the C band is present, indicates that no monkeypox virus antibody is detected in the specimen. The result is negative. 
Invalid: The control line fails to appear.Review the procedure and repeat the procedure with a new kit. If the problem persists, discontinue using the test kit immediately and contact your local distributor.