INTENDED USE
This product is used for the qualitative detection of IgG and IgM antibodies to monkeypox virus antibody in human serum, plasma or whole blood in vitro. Monkeypox virus (MPV) is a double-stranded DNA virus that belongs to the Poxviridae family with variola virus. The symptoms of infection are similar to those of smallpox, such as fever, headache, swollen lymph nodes, cough and extreme pain all over the body. Commonly known as "monkey smallpox", it is a Dangerous virus that can be spread through direct contact with a patient or infected animal, or through a patient's bodily fluids. The monkeypox virus was first discovered in monkeys from Africa in a laboratory in Copenhagen, Denmark, in 1958, and the world's first human case of monkeypox was reported in the Congo in 1970. A total of two virus strains have been found, the West African strain is less virulent; the other Congo Basin strain is more virulent and almost lethal. Judging from the prevalence of monkeypox in humans, the pathogenicity and infectivity of monkeypox are weaker than those of smallpox, but monkeypox is susceptible to many different animals and has a wide distribution range, which is easy to cause epidemics.
TEST PRINCIPLE
This product adopts the double antigen sandwich method and the technical principle of colloidal gold immunochromatography. During the test, the sample is dropped into the sample well of the reagent, and the chromatography is performed under the capillary effect. The human monkeypox abtibody (IgG and IgM) in the sample binds to the colloidal gold-labeled monkeypox monoclonal antigen, diffuses to the test area, and is captured by coated monkeypox monoclonal antibody II (anti-humam IgG and anti-human IgM), forming a complex to aggregate in the test area (test line IgG and test line IgM); the quality control area is coated with goat anti-mouse IgG antibody, which captures the colloidal gold-labeled antibody to form a complex and aggregate in the quality control area. The highly specific antigen-antibody reaction and colloidal gold immunochromatography technology are combined to qualitatively detect the content of IgG and IgM antibodies to monkeypox virus in serum, plasma or whole blood.Test principle: the combination of the analyte with the capture antibody on the membrane and the colloidal gold labeled antibody produces a color change, and the color intensity change has a correlation with the concentration of the analyte.
STORAGE AND STABILITY
The buffer shall be stored at 4℃ - 30℃ with a shelf life of 24 months. The test reagent shall be stored at 4℃ - 30℃ with a shelf life of 18 months. The test reagent should be used within 1 hour after opening. Please check the production date and shelf life on the label.
SAMPLE PREPARATION
- Monkeypox IgG/IgM Rapid Test Kit (Colloidal gold Assay) can be performed with serum, plasma and whole blood.
- To collect finger prick whole blood samples. Wash the patient's hand with soap and warm water or clean with an alcohol swab. Allow to dry. Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger. Puncture the skin with a sterile lancet. Rub the hand gently from wrist to palm to finger to form a rounded drop of blood over the puncture site. Transfer the finger blood sample to the cassette by using the micropipette/ dropper immediately.
- Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed samples.
- Test should be performed immediately after sample collection.
- Serum and plasma samples may be stored at 2-8℃ for up to 3 days. For long-term storage, samples should be kept below -20℃. Whole blood collected by venipuncture should be stored at 2-8℃ if the test is to be run within 2 days of collection. Do not freeze whole blood samples. Whole blood collected by fingertip should be tested immediately.
- Bring samples to room temperature prior to testing. Frozen samples must be completely thawed and mixed well prior to testing. Samples should not be frozen and thawed repeatedly
INTERPRETATION OF RESULTS
- Positive: a purplish red band appears on both the test line (T) and quality control line (C). The purplish red band on the IgG line indicates that IgG is detected; the purplish red band on the IgM line indicates that IgM is detected.
- Negative: a purplish red band only appears on the quality control line (C).
- Invalid: no purplish red band appears on the quality control line (C), indicating incorrect
operation or deterioration of the reagent. In this case, please read the operation manual
carefully again and retest with a new reagent.