猴痘抗原快速检测卡

广州华南生物工程有限公司

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NAME: Monkeypox Virus IgM/IgG Antibody Rapid Test Kit (Lateral Chromatography)

PRODUCT SPECIFICATION: 1 Test/Kit; 5 Test/Kit; 25 Tests/Kit

INTENDED USE:

The Monkeypox Virus IgM/IgG Antibody Rapid Test Kit is used for the qualitative detection of Monkeypox Virus IgM/IgG antibody in human serum, plasma or whole blood sample. It is intended for in vitro diagnostic use, and for professional use only.

PRINCIPLE:

The Monkeypox Virus IgM/IgG Antibody Rapid Test Kit is designed to simultaneously detect and differentiate IgG and IgM antibodies to monkeypox virus in human serum, plasma, whole blood. The Monkeypox Virus IgM/IgG test device has 3 pre-coated lines, "G" (Monkeypox IgG Test Line), "M" (Monkeypox IgM Test Line) and "C" (Control Line) on the surface of the membrane. The "Control Line" is used for procedural control. When a specimen is added to the sample well, anti-Monkeypox IgGs and IgMs in the specimen will react with recombinant Monkeypox virus envelope proteins conjugates and forms antibody -antigen complex. As the complex migrates along the test device via capillary action, it will be captured by the relevant anti-human IgG and or anti-human IgM immobilized in two test lines across the test device and generate a colored line. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

CAUTIONS:

1. This kit is for In Vitro Diagnostic use only. 2. For healthcare professionals and professionals at point of care sites. 3. Do not touch the reaction area of test strip. 4. Please read all the information in this leaflet before performing the test. 5. The test kit should remain in the sealed pouch until use. 6. All specimen should be considered potentially hazardous and handled in the same manner as an infectious agent. 7. Do not use test kit beyond the expiration date. 8. To avoid erroneous results, specimen must be processed as indicated in the test procedure section. 9. Testing should be applied by professionally trained staff working in certified laboratories or clinics at which the sample(s) is taken by qualified medical personnel. Wear protective clothing such as laboratory coats, disposable gloves, and eye protection. 10. Do not reuse test cassette and dropper. 11. The test result should be interpreted by the physician along with clinical findings and other laboratory test results. 12. Disposal: All specimen and the used-kit has the infectious risk. The used test cassette should be discarded according to federal, state and local regulations.

广州华南生物工程有限公司