KaiBiLi COVID-19 Antigen Rapid Test Device is an in vitro diagnostic test based on the principle of immunochromatography for the qualitative detection of 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swab or nasopharyngeal swab. The detection is based on the antibodies which were developed specifically recognizing and reacting with the nucleoprotein of 2019 Novel Coronavirus. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Patients with negative result should be treated as presumptive. Negative results do not rule out SARS-CoV2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be confirmed with a molecular assay, if necessary, for patient management.

Component:

• COVID-19 antigen test devices

• Sterilized swabs

• Extraction tubes (with 0.5mL extraction buffer)

• Nozzles with filter

• Tube Stand

• Package Insert