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.
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.