Product Name: (CFDA&CE) Livzon Diagnostic Kit for Igm/Igg Antibody Group: All Certification: CE, MSDS, ISO13485, Cfda Type: Blood Testing Equipments Classification: Igm/Igg , Rapid Test, Blood Test Transport Package: 20 Person-Share / Box Specification: Box size inner box size 16*14*7Cm, 20 persons/box; Origin: China HS Code: 38220090 Product Description [Test Principle]This product contains one IgM test cassette and one IgG test cassette.The IgM test uses colloidal gold immunochromatography technologyto detect the IgM antibody. TheIgM antibody labeled by colloidal gold is coated on the conjugate pad. Meanwhile, on the cellulose nitrate membrane, the antigens are coated in the test area, and goat anti-mouse antibody is coated in the control area. While testing, the IgM antibody in the testsample (the specific IgM antibody and non-specific IgM antibody) binds with the colloidal gold labeled anti-human IgM antibody and forms an immune complex. The immune complexmoves along the membrane through chromatography. If there is specificIgM antibody to in the test sample, it will be captured by the antigens coated in the test area, forming a visible band (test line); The free colloidal gold conjugate or immune complexcontinues to move forward, and binds specifically with the goat anti-mouse antibody coated in the control area, forming a visible band (control line). If the test sample doesn't contain anyIgM antibody, only a control line will appear. The IgG test uses colloidal gold immunochromatography technology to detect theIgG antibody. The anti-human IgG antibody labeled bycolloidal gold is coated on the conjugate pad. Meanwhile, on the cellulose nitrate membrane, the antigens are coated in the test area, and goat anti-mouse antibody is coated in the control area. While testing, the IgG antibody in the test sample (the specific IgG antibody and non-specific IgG antibody)binds with the colloidal gold labeled anti-human IgG antibody and forms an immune complex. The immune complex moves along the membrane through chromatography. If there is specific IgG antibodyin the test sample, it will be captured by the antigens coated in the test area, forming a visible band (test line); The free colloidal gold conjugate or immune complex continues to move forward, and binds specifically with the goat anti-mouse antibody coated in the control area, forming a visible band (control line). If the test sample doesn't contain anyIgG antibody, only a control line will appear.mple well (S) of IgM test card and IgG test card, and add vertically2 drops (about 100μL) of sample diluent.b) Within 1-15 minutes after sample addition, the result can be interpretedas positive while both the control line and test line appear. If only thecontrol line appears and the test line does not appear in 15 minutes,the result can be interpreted as negative. It is invalid to read result after15 minutes.[Interpretation of Test Result]1. Positive result:a) IgM positive, IgG positive: IgM test cassette appears both controlline (C) and test line (T); IgG test cassette appears both control line (C)and test line (T).b) IgM positive, IgG negative: IgM test cassette appears both controlline (C) and test line (T); IgG test cassette appears only control line(C),but no test line (T).c) IgM negative, IgG positive: IgM test cassette appears only controlline(C), but no test line (T); IgG test cassette appears both control line(C) and test line (T).2. Negative result: IgM test cassette appears only control line(C), butno test line (T); IgG test cassette appears only control line(C), but notest line (T).3. Invalid result: If IgM and/or IgG test cassette appears no control line(C),no matter whether the test line (T) appears or not, the test result is invalid.A repeat test should be done in case of invalid result appears.[Limitations of the Test Procedures]1. The product can only be used for in vitro test of individual's serum,plasma or whole blood samples.2. A infection may not be excluded if the test result is negative.3. The test result is only for clinical reference and should not be regardedas the only reference for clinical diagnosis and treatment. The clinicalmanagement of patients should be considered in combination with theirsymptoms, physical signs, medical history, other laboratory tests (especiallyetiology test), treatment response and information.4. In patients with impaired immune function or receiving immunosuppressivetherapy, the value of serological antibody test is limited.5. IgM antibody positive not only occurs in primary infection, but alsoin secondary infection.6. The IgM and IgG antibody which thisproduct targets does not directly reflect the presencein the sample.[Warnings and Precautions]1. The product is for in vitro diagnosis only.2. Operation and interpretation of the result must be carried out in strict3. The product is intended for qualitative test, and it cannot get a quantitativeresult.4. The kit should be used within the shelf life.5. The test cassettes and pipettes are for single use and cannot be reused.6. Because of the difference in titers of the samples, the test line willshow different color intensity, all of which indicate a positive result. Thecolor intensity of the test line cannot be used as a reference base fordetermining the antibody titer in the sample.7. Before testing, the samples stored at low temperature shall standto reach the room temperature and be well mixed.8. An inactivation of 56ºC incubation for 30 minutes does not influencethe test result.9. Samples and wastes must be handled as potential infectious sources,and the desiccant in the aluminum foil bag is inedible.Name: Zhuhai Livzon Diagnostics Inc.Address: No. 266 Tongchang Road, Xiangzhou District, 519060 Zhuhai,Guangdong, P. R. ChinaName: Shanghai International Holding Corp. GmbH (Europe)