【Product name】

Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Detection Kit (Quantum Dot-based Fluorescence Immunochromatography)

【Packing specifications】

20T/kit, 100T/kit

【Intended Use】

For rapid and qualitative detection of novel coronavirus (2019-nCoV) IgM/IgG antibodies in human whole blood, plasma or serum samples. It is used as auxiliary diagnosis of clinical infections or suspected patients.

【Test Principle】

This kit uses a quantum dot fluorescence immunochromatographic technique to detect the novel coronavirus (2019-nCoV) IgM/IgG antibody. The test strips were prepared with a novel coronavirus-recombined antigen-labeled quantum dot microspheres as a binding pad. The nitrocellulose membrane was coated with anti-human IgG (T1), anti-human IgM (T2), and a new type of coronavirus antigen (C line). During lateral chromatography, when the test sample contains a novel coronavirus antibody (IgG/IgM), it can specifically bind to the antigen labeled on the quantum dot microspheres and be captured by the Anti-Human IgG/IgM at the T1/T2 position to generate Immune complex. The captured quantum dot microspheres are excited by ultraviolet light (wavelength 365nm, power 3W) to generate a red fluorescent signal.

【Main Components】

Note: Do not mix reagents between different batches.

【Storage Conditions and Validity】

4℃~30℃, stored in a dry and dark place, valid for 24 months. See the package box for the production date, production batch number, and expiration date.

【Applicable Instrument】

UV flashlight (wavelength 365nm, power 3W), fluorescence immunoassay analyzer (Suzhou Hemai Precision Instrument Co., Ltd., Cat#FIC-S100, Registration No. 20172401387) or other instruments with the same detection performance.

【Sample Requirements】

1. There is no special requirement for the subject before sample collection, and fasting is not required.

2. Collect serum, plasma, or fingertip blood according to conventional methods.

3. Avoid repeated freeze-thaw samples. Samples stored at low temperature should be equilibrated to room temperature and thoroughly mixed before testing.

【Testing Procedure】

1.  Remove the test card from the aluminum foil bag and place it horizontally on a clean operating table.

2. Add samples

² Serum and plasma samples: add 10μl of sample to the sample well first, then add 100μl of sample dilution buffer (The sample and sample dilution buffer can also be mixed before adding to the sample well.).

² Fingertip blood: 1 drop of fingertip blood sample is directly dripped into the sample well, and then 3 drops of sample dilution buffer can be added. The blood sample and dilution buffer can also be mixed before adding to the sample well.

3. Let it stand still at room temperature for 15 minutes, observe the results. Reading the results after 30 minutes is invalid.

【Positive Judgment Value or Reference Interval】

This kit is a qualitative reagent. There is no reference value for the naked eye interpretation. The referencevalue for the instrument interpretation has been preset in the corresponding software.

【Interpretation of Test Results】