PURPOSE OF USE
This Product is used for the in Vitro Qualitative Detection of SARS_CoV-2 Antigen in Human Saliva Samples. This Product is intended for Home Self-Testing as a Rapid Test for Novel Coronavirus Infections. Both Symptomatic and Asymptomatic Infections can be tested. Final Diagnosis should be made by Medical Personnel based on Laboratory Results and Symptom Analysis. This Product is suitable for users 10 Years of Age and older. Parents or authorized Adults should assist Users under 10 Years of Age in performing the Test.
This Product uses the Double Antibody Sandwich Method to detect the SARS-CoV-2 N Protein. If the Sample contains the Coronavirus Antigen, both the Test Line (T) and the Control Line (C) appear and the Result will be positive. If the Sample does not contain Coronavirus Antigen or no Coronavirus Antigen is detected, the Test Line (T) does not appear, only the Control Line (C) appears and the Result will be negative.