SARS-COV-2 Antigen Rapid Test (Saliva)

NTENDED USE
SARS-CoV-2 Antigen Rapid Test (Saliva) is intended for the qualitative detection of SARS-CoV-2 Antigen (Nucleocapsid protein) in human saliva samples in vitro.
The positive results indicate the existence of SARS-CoV-2 antigen. It should be further diagnosed by combining the patient’s history and other diagnostic information [1]. The positive results do not exclude bacterial infection or other viral infection. Pathogens detected are not necessarily the main cause of disease symptoms.
The negative results do not exclude SARS-CoV-2 infection, and should not be the only basis for treatment or patient management decisions (including infection control decisions). Pay attention to the patient’s recent contact history, medical history and the same signs and symptoms of COVID-19, if necessary, it is recommended to confirm these samples by PCR test for patient management.
It is for laboratory personnel who have received professional guidance or training and have professional knowledge of in vitro diagnosis, also for relevant personnel who have received infection control or nursing training [2].

REAGENT STORAGE AND STABILITY
Store the kit at 2-30°C/ 36-86°F, dry, out of direct sunlight, valid for 24 months. Do not freeze the kit. The test device should be used within 60 minutes after opening the foil pouch. For production date and expiration date, please refer to the product label.