Detailed description
1.The SARS-CoV-2 Antigen Rapid Test Kit (Saliva Test) is for in vitro diagnostic use only. This test should be used for the detection of SARS-CoV-2 antigens in human Saliva specimens.
2.The SARS-CoV-2 Antigen Rapid Test Kit (Saliva Test)will only indicate the presence to SARS-CoV-2 in the specimen and should not be used as the sole criteria for the diagnosis of SARS-CoV-2 infections.
3.If the symptom persists, while the result from SARS-COV-2 Rapid Test is negative or non-reactive result, it is recommended to re-sample the patient few hours later.
4.As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
5.If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of SARS-CoV-2 infection.
6.The potential impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated in the test.
7.Due to inherent differences between methodologies, it is highly recommended that, prior to switching from one technology to the next, method correlation studies are undertaken to qualify technology differences. One hundred percent agreement between the results should not be expected due to differences between technologies.
8.Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay