SARS-Cov-2 Antigen Rapid Test Kit (Colloidal Gold)

• INTENDED USE

This Product is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with SARS-COV-2. Any reactive specimen with the SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) must be confirmed with an alternative testing method(s) and clinical findings.

• 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.

The nasopharyngeal swab (NPS) and Oropharyngeal swab(OPS) detection is a common method for the diagnosis of infection with SARS-CoV-2.

The SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) detects nucleocapsid protein antigen from COVID-19 in the pharynx swab. It can be performed within 20 minutes by minimally skilled personnel with the Immunochromatographic analyzer or not.

• PRODUCT SPECIFICATION

Specimen: Naso/Oropharyngeal swab

Reaction Time: 15 min

Packing Size: 25Test/Kit

Storage Temperature: 4-30℃

Qualification: CE