SARS-Cov-2 Antigen Rapid Test Kit

• INTENDED USE

The SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence immunochromatography)  is  intended for vitro qualitative detection of nucleocapsid antigens of SARS-CoV-2 in human nasopharyngeal swab (NPS) and Oropharyngeal swab(OPS).

For professional in vitro diagnostic use only. 

• CLINICAL SIGNIFICANCE

The SARS-CoV-2 belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the SARS-CoV-2 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. SARS-CoV-2 antigens can usually be detected in upper respiratory tract samples during the acute phase of infection. A positive result indicates the presence of viral antigens, but the clinical and medical history and other diagnostic information must be combined to determine the infection status. For areas with limited PCR resources, antigen testing can be used for aiding in the diagnosis of SARS-CoV-2 suspect patients.

• PRODUCT SPECIFICATION

Specimen: Nasopharyngeal swab (NPS) and Oropharyngeal swab(OPS)

Reaction Time: 15 min

Storage Temperature: 4-30℃

Packing Size: 25 Test/Kit

Qualification: CE