SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) is a lateral flow immunoassay intended for the qualitative detection of nucleoprotein from SARS-CoV-2 innasal swabs,pharyngeal swabs,saliva. It is suitable for self-testing as a test and provides a preliminary test result to aid in the diagnosis of infection with individuals suspected of COVID-19.

Advantage

1. The detection time is short,and results are available within 15 minutes
2. Use nasal swabs, nasopharyngeal swabs, throat swabs, and saliva samples
3. Using imported raw materials,and the products have a high sensitivity and specificity.
4. Ideal high-capacity COVID-19 screening reagent, which can supplement Nucleic Acid testing
5. Simple and convenient operation, no special equipment and training are required
6. The product has passed many national certifications and laboratory tests

Specification Type

Specification：1T/box, 5T/box,10T/box,20T/box,25T/box,50T/box,100T/box

Sample types：nasopharyngeal swabs, nasal swabs, throat swabs and saliva samples

nasal swabs：Sensitivity： 96.38%；Specificity：100%

throat swabs：Sensitivity： 97.41%；Specificity：99.53%

Saliva：Sensitivity： 97.48%；Specificity：99.65%

SUMMARY AND EXPLANATION OF THE TEST

The novel coronavirus belong to the β genus.COVID-19 is an acute respiratory infectious disease. People are generally susceptible.

Currently, the patients infected by the novel coronavirus are the main source of infection;asymptomatic infected people can also be an infectious source.Based on the current epidemiological investigation,the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough.Nasal congestion,runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Antigen detection is a common method for the diagnosis of infection with novel coronavirus. This test is an immunological diagnostic test used for detection of SARS-CoV-2 nucleoprotein antigen based on the colloidal gold-immunochromatography assay. This method is rapid and convenient to use and requires few equipment.It can be performed within 15-20 minutes by self-test.

TEST PRINCIPLCE

This kit adopts colloidal gold-immunochromatography assay .

The test card contains:

1. Colloidal gold-labeled mouse nucleoprotein monoclonal antibody and quality control antibody complex.
2. Nitrocellulose membranes immobilized with test lines (T line ）and one quality control line (C line).

When an appropriate amount of sample is added to the sample well of the test card, the sample will move forward along the test card under capillary action.

If the sample contains an antigen of SARS-CoV-2, the antigen will bind to the colloidal gold-labeled SARS-CoV-2 antibody, and the immune complex will be captured by the monoclonal anti-human antibody immobilized on the nitrocellulose membrane to form a burgundy line , showing that the sample is positive for antigen.

TEST PROCEDURE

Saliva swabs

Innasal swabs，pharyngeal swabs