Description
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 the clinical presentation and results of other laboratory tests.
The results are used for the detection of SARS-CoV-2 nucleocapsid protein antigens. During the acute phase of infection, an antigen is usually detectable in upper respiratory specimens.
The test is a qualitative membrane immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens in human oral fluid specimens. Antibodies to the SARS-CoV-2 nucleocapsid protein coat the area of the test lines.
During the test, the sample reacts with the antibody-coated particles of the SARS-CoV-2 nucleocapsid protein in the test. The mixture then migrates up the membrane by capillary action and reacts with the SARS-CoV-2 nucleocapsid protein antibody in the region of the test lines.
If the sample contains SARS-CoV-2 antigen, a colored line will appear in the test line region as a result.
If the sample does not contain SARS-CoV-2 antigen, no colored line will appear in the test line region, indicating a negative result.
As a procedural control, a colored line will always appear in the control line region, indicating that the correct volume of specimen has been added and membrane wicking has occurred.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is required to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The identified agent may not be the definitive cause of the 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 test if necessary for patient management. Negative results should be considered in the context of the patient's recent exposures, medical history, and the presence of clinical signs and symptoms consistent with COVID-19.

How to use
Allow the test fixture, pickup device, buffer, and/or controls to reach room temperature (15-30°C) before testing.

Sample collection :
The oral fluid sample should be collected using the collection bag provided with the kit. Follow the detailed instructions for use.
No other collection devices should be used with this test.
Collected oral fluid may be used at any time of day.
Samples should be tested as soon as possible after collection. If the oral fluid is not processed immediately, it is stable for up to 8 hours at room temperature and for 24 hours at 2 to 8°C.
Important: Before collecting oral fluid, instruct patients not to put anything into their mouth, including food, drink, gum, or tobacco products for at least 10 minutes before collection.

Ask patients to cough deeply 3-5 times. It is recommended to collect the oral fluid after a deep cough in the morning.
Remove the collection device and collect oral fluid sample. If not enough oral fluid has been collected, repeat the steps above for specimen collection.
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