Rapid Sars-CoV-2 Ag test (self testing) 1 pc

The SARS-CoV-2 Antigen Rapid Self Test is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal swabs directly from individuals with suspected COVID-19 from their healthcare provider within the first seven days after the onset of symptoms. The SARS-CoV-2 Antigen Rapid Self Test can also be used to test samples from asymptomatic individuals. The SARS-CoV-2 Antigen Rapid Self-diagnosis Test does not distinguish between SARS-CoV and SARSCoV-2.

INTENDED USE
The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. The SARS-CoV-2 Antigen Rapid Test can also test specimens from asymptomatic individuals. The SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of 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. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of
disease. Negative results, from patients with symptom beyond seven days, should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management. Negative results 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. The SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. SARS-CoV-2 Antigen Rapid Test is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.

SUMMARY
The novel coronaviruses belong to the β genus.1 COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Materials Provided
• Test Cassettes • Extraction Buffer Tubes
• Disposable Swabs* • Package Insert
• Biohazard waste bag
* The Disposable Swabs are produced by another manufacturer. Nasal swabs in this kit.