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Coronavirus Test Kit

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Product Details

[Product Name] 

Generic name: 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based) 


[Packaging Specifications] 

50 Tests /Package 


[Intended Use] 

The kit is suitable for the qualitative detection of 2019-nCoV IgG/IgM antibodies in human serum, plasma and whole blood. 2019-nCoV is a Betacoronavirus, with enveloped particles of round or oval shape, often pleomorphic, and a diameter of 60-140 nm. Its genetic characteristics are significantly different from SARS-CoV and MERS-CoV. Current studies show that 2019-nCoV shares > 85% genome identity to bat SARS-like coronavirus (bat-SLCoVZC45), which was identified in Wuhan viral pneumonia cases in 2019. On January 12, 2020, the WHO officially named this virus as Novel Coronavirus (2019-nCoV), and renamed to SARS-Cov-2 on February 11 2020. The disease caused by SARS-Cov-2 is COVID-19. Normally, the human body produces IgM and IgG antibodies after virus infection. IgM antibody levels normally start rising within 1 week and reach peak titer within 2-3 weeks after initial infection. IgG antibody appears later than IgM antibody. It usually appears at day 14 after infection, reaches peak titer in the 5 th week after infection, and lasts for 6 months or even several years. When IgG titer in the convalescence period of a patient increases or decreases 4 times or more compared with that in the acute period, it has clinical diagnostic significance for virus infection. 


[Principle] 

The detection kit uses the principle of solid-phase immunochromatography: the separation of components in a blood sample through a medium by capillary force. 2019- nCoV specific IgM and IgG antibodies in blood samples bind to colloidal gold-labeled viral antigen. Each cassette is a dry medium that has been coated with a recombinant 2019-nCoV antigen (conjugate pad), mouse anti-human IgM antibody (“T1” test line) , mouse anti-human IgG antibody (“T1” test line) as well as a reference protein (“C” control line) (Figure 1). Once the diluted serum/plasma/ whole blood /peripheral blood is loaded into the sample well, it diffuses upward via capillary force. When it passes through the conjugate pads, the colloidal gold-labeled 2019-nCoV antigens will bind to 2019-nCoV IgM and IgG, forming colloidal gold-labeled antigenIgM and/or IgG complexes. The complexes continue to flow along the nitrocellulose membrane by capillary force. If 2019 nCoV IgM antibody is present in the sample, the T1 test line will be bound by the mIgM-IgM- colloidal gold-labeled antigen complex thereby generating red color (red T1 line). If there is no 2019 nCoV IgM antibody present in the sample, no color is generated. The unbound immune complexes and antibodies continue to flow to the T2 test line, where mouse anti-human IgG antibody binds with 2019 nCoV IgG antibody to form mIgG-IgG-colloidal gold-labeled antigen complex and generating red color (red T2 line). The unbound colloidal gold conjugates continue to flow and are bound by the line C (Control line), indicating the reaction is completed.


[Storage Conditions and Validity Period] 

The kit should be stored at 4-30°C in its sealed aluminium foil packaging. It is valid for 18 months from date of manufacturing (refer to packaging for expiration information). Once the individual test cassette is opened (4-30 ℃ with < 65% humidity), it should be used within 1 hour. 


[Sample Requirements] 

  1. The assay is suitable for human serum/plasma/whole blood.

  2. Sediments or suspensions may affect results. Remove by centrifugation at 3,000g for 10 min before testing.

  3. Hemolyzed, or hyperlipidemic blood samples should not be tested.

  4. Collect whole blood/plasma samples using a heparin sodium or EDTA anticoagulant blood collecting tube. Samples should be run on the same day as collection. If not, whole blood samples can be stored at 2-8°C for 3 days, and serum/plasma samples can be stored at 2-8°C for 7 days, or at -20 °C or lower for 12 months. Avoid repeated freezing and thawing of samples.

  5. Bring the sample to room temperature (18°C-28°C) before processing. Frozen samples should be completely thawed, and mixed well before testing. Avoid repeated freezing and thawing. 


[Instruction] 

Please read instructions carefully before use. 1. Bring the Test cassette, sample diluent, and sample to room temperature before testing. Conduct test at room temperature. 2. Take out the test cassette from the aluminum foil bag and place it on a flat and dry surface. 3. Add one drop of sample to the sample well of the cassette using a pipette dropper, followed by adding 3 drops of diluent into the same well after opening the cap of the diluent bottle. 4. The results can be interpreted after 10 minutes. 5. After the test, the used test cassette, and pipette dropper shall be discarded as biomedical waste.

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