Intended use
This product is used for the qualitative detection of SARS-CoV-2 (COVID-19) IgM and IgG Antibodies in human serum, plasma, whole blood or fingertip blood.
How to use it
Principle
This kit is a colloidal gold immunochromatographic testing product for the qualitative determination of IgM and IgG antibodies against novel coronavirus (COVID-19) in human serum, plasma, whole blood or fingertip blood. Antibody-antigen sandwich one-step assay has been used in this detection. For the test line (M line and G line), colloidal gold conjugated COVID-19 antigen is used as a detector and coated on the conjugate pad, and mouse anti-human IgM antibody and mouse anti-human IgG antibody are used as the two captures and coated separately on nitrocellulose membrane. For the quality control line (C line), colloidal gold conjugated rabbit IgG is used as a detector and coated on the conjugate pad and goat anti-rabbit IgG antibody is used as the capture and coated on nitrocellulose membrane. When a sample is loaded on the conjugate pad, the IgM or IgG antibody against the virus antigen in the sample specifically binds to the virus antigen that is conjugated with gold, forms an IgM or IgG antibody-antigen gold complex, then the complex migrates on the nitrocellulose membrane and is captured by mouse anti-human IgM or IgG antibody and immobilized on the nitrocellulose membrane, and then red bands appear on the detection line (M line and G line). The gold labeled rabbit IgG is captured by goat anti rabbit IgG antibody and forms a red quality control line (C line) on the nitrocellulose membrane at the same time.
Sample requirements
1. The sample can be whole blood or serum, plasma. The anticoagulants used for plasma collection could be sodium citrate, EDTA.2Na or heparin. Venous blood or fingertip blood should be collected in sterile condition.
2. The sample should be tested immediately after collection.
3. If immediately testing is not available, the sample can be stored at 2-8¡æ for 48 hours and -20¡æ(not for whole blood) for 3 months. While in the testing, the samples need to be restored to room temperature at 10-30¡æ before loading.
Performance Characteristics
1.Tests evaluated by an independent clinical laboratory showed that Novel Coronavirus (COVID-19) IgG/IgM Antibody Test Kit (Colloidal Gold) gave 91.4% of sensitivity and 97.1% of specificity compared to fluorescence RT-PCR assay.
2. Tests evaluated in our laboratory showed that Novel Coronavirus (COVID-19) IgG/IgM Antibody Test Kit (Colloidal Gold) gave 100% positive response in 20 of the positive control and 99% negative response in 200 of health human serum samples..
Storage and validity
This kit shall be stored at 4¡æ-30¡æ,with a validity period of 12 months. After the aluminum foil bag is opened, it should be used within 15 minutes.
