The COVID-19 Antigen Saliva Test Kit is used for the qualitative detection of novel coronavirus (COVID-19) antigen in saliva sample, only for in vitro diagnostic use. The novel coronaviruses 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 is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively. This product is sold only for professional use.
This kit is based on the principle of highly specific antibody-antigen reaction and colloidal gold labeling immunochromatographic analysis technology. The reagent contains COVID-19 monoclonal antibody prefixed in the test area (T) on the membrane and the COVID-19 monoclonal antibody coated on the label pad-colloidal gold mixture. The sample is dripped into the sample well and reacts with the COVID-19 monoclonal antibody which is bound to the pre-coated colloidal gold particles when testing. Then the mixture is chromatographed upwards with capillary effects. If it is positive, the antibody labeled by colloidal gold particles will first bind to the COVID-19 virus in the sample during chromatography. Then the conjugates are bound by the COVID-19 monoclonal antibody fixed on the membrane, and a red line appears in the test area (T). If it is negative, there's no red line in the test area (T). Whether the sample contains COVID-19 antigen or not, a red line will appear in the quality control area (C). The red line appearing in the quality control area (C) is the standard for judging whether there are enough samples and whether the chromatographic process is normal, and it also serves as the internal control standard for the reagent.
1. This kit is only for the detection of COVID-19 antigen in human saliva.
2. The accuracy of the test depends on the sample collection, handing, storage and operation procedure. Improper sample collection, improper storage of samples, unfresh samples, or repeated freeze-thaw cycles of samples will affect the test results.
3. The test cassette only provides qualitative detection of the SARS-COV-2 in the sample. If you need to detect the specific content of an indicator, please use the relevant professional instruments.
4. The test result of this kit is for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests, and treatment responses.
5. Due to the limitation of the method of antigen detection reagents, its analytical sensitivity is generally lower than that of nucleic acid reagents. Therefore, the experimenters should pay more attention to the negative results and need to make a comprehensive judgment in combination with other test results. It is recommended to review the suspicious negative results by using nucleic acid detection or virus culture identification methods.
6. Analysis of the possibility of false negative results: 1.Unreasonable sample collection, transportation and processing, and too low concentration of tested substances in samples may lead to false negative results. 2.Genetic variations of virus can cause changes in antigenic determinants, which can lead to false negative results. This is more likely to occur by using monoclonal antibody reagents. 3.The optimal sample type and sampling time (peak virus titer) after infection have not been verified, so collecting samples fractionally, in multiple parts on the same patient may avoid false negative results
MATERIALS PROVIDED (Per Single TEST)
1 x One pouch contains a test cassette and a desiccant. The desiccant is for storage purposes only and is not used in the test procedures.
1 x Sample extraction buffer
1 x Plastic cup
1 x Pipette dropper
1 x Reaction tube
1 x Package Insert (Instructions)
THE PRODUCT IS REGITERED WITH THE NDO