The kit is used for in vitro qualitative detection of SARS-CoV-2 antigen in saliva samples.
As a new type, SARS-CoV-2 is a kind of β-CoVs. It can cause viral pneumonia, with main clinical manifestations of fever, fatigue and dry cough. A few patients are accompanied by nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Critical cases often develop dyspnea and/or hypoxemia after a week, and those at serious condition rapidly progress to acute respiratory distress syndrome, septic shock, kidney failure and death.
This product adopts a lateral flow immunoassay method for the qualitative detection of SARS-CoV-2 Ag in saliva samples from suspected patients. In the acute phase of infection, antigens are usually detected in saliva samples. Positive result indicates the presence of viral antigens, but the clinical relevance of the patient's medical history and other diagnostic information is also necessary to determine the infection status. A positive result can not exclude bacterial infection or co-infection with other viruses.
The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests.
This kit is an immunoassay based on the principle of double antibody sandwich technology. As an indicator marker, the 2019-nCoV monoclonal antibody labelled with a marker is sprayed on the binding pad. During the test, the SARS-CoV-2 Ag in the sample is combined with the labelled 2019-nCoV monoclonal Ab to form an Ag-Ab complex. This complex migrates upwards on the membrane by capillary effect until it 12 is captured by another 2019-nCoV monoclonal Ab pre-coated at the test line to form a sandwich complex. If there is SARS-CoV-2 Ag in the sample, a red band will appear in the T area of the reading window. Otherwise, it is a negative result. The control line (C) is used for program control and should always be displayed if the test procedure is executed correctly.
Read the instructions carefully before testing. Please return all reagents to room temperature before testing, and the test should be performed at room temperature. Do not eat, smoke, chew gum or similar items within 30 minutes prior to test. If the saliva secretion is insufficient or there is food residue in the mouth, you can use adequate water gargle.
【Test Method 1 】
1. Take out the test card, take off the hat at the bottom of the test card and expose the absorbent pad.
2. Put the absorbent pad between the upper and lower lips, close the lips, concentrate the saliva in the front of the mouth, and soak the absorbent pad in the saliva. (You need to keep the absorbent pad in close contact with saliva, too little saliva or the absorbent pad can't contact saliva may cause test errors).
3. Wait for about 1-2 minutes and observe the reading window of the test card, when the red liquid is found flowing, take out the test card from the mouth and put on the hat. Place the test card flat on the desktop.
4. Start the timer, and read the results after 15min. The result after 20min is invalid.
【Test Method 2】
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