Package and specification
20 Tests/box (1Test/bag ×20 Bags)
For in vitro qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first 5 days after onset of symptoms. This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, not for at-home testing.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) is an enveloped non-segmented positive-sense RNA virus. It is the cause of coronavirus disease (COVID-19), which is contagious in humans. SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M), and nucleocapsid (N).
The antigen is generally detectable in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results should be treated as presumptive, which do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.
For in vitro diagnostic use only. For professional use only
JOYSBIO Biotechnology’s SARS-CoV-2 Antigen Rapid Test Kit uses an immunocapture method, it is designed to detect the presence or absence of SARS-CoV-2 nucleocapsid proteins in respiratory samples from patients with signs and symptoms of infection who are suspected of COVID-19.
Key components: the anti-nucleocapsid protein antibody and chicken IgY labeled by colloidal gold, the nitrocellulose membrane coated with anti-nucleocapsid protein antibody, and goat anti-chicken IgY antibody.
When specimens are processed and added to the test device, SARS-CoV-2 antigens present in the specimen bind to antibodies conjugated to colloidal gold in the test strip. The antigen-conjugate complexes migrate across the test strip to the reaction area and are captured by a line of antibodies bound on the membrane. A color band will show up when antigen-conjugate is deposited at the Test “T” position and the Control “C” position on the device.