COVID-19 Antigen Rapid Test (Oral Fluid) ,Detection Of SARS-CoV-2 Nucleocapsid Protein Antigens
COVID-19 Antigen Rapid Test (Oral Fluid) , Detection of SARS-CoV-2 nucleocapsid protein antigens
COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens present in human oral fluid.
For professional in vitro diagnostic use only.
INTENDED USE
The COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.
Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
SUMMARY
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.
PRINCIPLE
The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens in human oral fluid specimen. SARS-CoV-2 nucleocapsid protein antibody is coated in the test line region. During testing, the specimen reacts with SARS-CoV-2 nucleocapsid protein antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2 nucleocapsid protein
antibody in test line region. If the specimen contains SARS-CoV-2 Antigens, a colored line will appear in test line region as a result of this. If the specimen does not contain antigens to SARS-CoV-2, no colored line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
REAGENTS
The test contains anti-SARS-CoV-2 nucleocapsid protein antibody as the capture reagent and anti-SARS-CoV-2 nucleocapsid protein antibody as the detection reagent.
DIRECTIONS FOR USE
Allow the test device, collection device, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
Specimen Collection
Important: Before collecting oral fluid, instruct the patients not to place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes prior to collection.
Instruct the patients to deeply cough 3-5 times. It is recommended to collect oral fluid after deep coughing in the morning.
①Remove the collection device and collect oral fluid specimen.
If there’s not enough oral fluid collected, repeat the above specimen collection steps.
Specimen Extraction
②Mix the buffer with the collected oral fluid. Gently shake or squeeze the tube with mixture for 10 seconds to mix well.
NOTE: The storage of the specimen after extraction is stable for 2 hours at room temperature or 24 hours at 2-8°C.
Test Reaction
Remove the test device from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
③Add Extracted specimen to the Test Device, Wait for the colored line(s) to appear.
Read the result at 15 minutes. Do not interpret the result after 20 minutes. Refer to the Procedure Card for detailed information of the testing procedure.
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COVID-19 Antigen Rapid Test Oral Fluid Detection Of SARS-CoV-2 Images
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