A rapid test for the qualitative detection of COVID-19 antigen in saliva and nasopharyngeal swab.
INTENDED USE:
The COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Saliva and Nasopharyngeal Swab. The identification is based on the monoclonal antibodies specific for the Nucleocapsid(N)protein of SARS-CoV-2. It is intended to aid in the rapid differential diagnosis of COVID-19 infections. Store as packaged at room temperature or refrigerated (2 to 30 ℃). Read the result at 10 minutes. Do not interpret the result after 20 minutes.
PRINCIPLE:
The COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) is a qualitative, lateral flow immunoassay for the detection of the N protein of SARS-CoV-2 in saliva and Nasopharyngeal Swabs. Within this test, antibodies specific to the N protein of SARS-CoV-2 are separately coated on the test line regions of the test cassette. During testing, the extracted specimen reacts with the antibody to N protein of SARS-CoV-2 that are coated onto particles. The mixture migrates up the membrane to react with the antibody to N protein of SARS-CoV-2 on the membrane and generate one colored line in the test region. The presence of this colored line in the test region indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.
Delivery information: Materials provided: Test cassettes, extraction reagents, collection tubes, saliva collectors, sterile swabs, droppers, package insert in English, workstation.
Caution: For professional in vitro diagnostic use only.