SARS-CoV-2 Antigen Rapid Test Kit-ShenZhen Kindle Medical Devices Co.LTD

SARS-CoV-2 Antigen Rapid Test Kit

This kit is used for the in vitro qualitative detection of SARS-CoV-2 antigens in human nasal secretions.

This kit is only used as a supplementary test for suspected cases with a negative nucleic acid test for the SARS-CoV-2, or used together

with nucleic acid for the diagnosis of suspected cases. It cannot be used as a basis for the diagnosis and exclusion of pneumonia caused by

SARS-CoV-2 infection, nor is it suitable for screening of the general population. This kit is only for use by medical institutions. The test results

combined with clinical and other laboratory indicators can be used for the auxiliary diagnosis of SARS-CoV-2 pneumonia.

SARS-CoV-2 is a β-coronavirus. SARS-CoV-2 pneumonia is an acute respiratory infectious disease, and the population is generally

susceptible. The source of infection currently seen is mainly patients infected by SARS-CoV-2, and asymptomatic infection may also become

the source of infection. According to the current epidemiological investigation, the incubation period is 1-14 days, mostly 3-7 days. Mainly

manifested as fever, dry cough, and fatigue. A few patients have nasal congestion, runny nose, sore throat, myalgia and diarrhea.

This kit uses the principle of immunochromatography. The test card uses colloidal gold as a tracer to detect the SARS-CoV-2 N antigen

in human nasal secretions. Coat the nitrocellulose membrane of the test strip with anti-SARS-CoV-2 N antigen monoclonal antibody (capture

antibody) as the detection line (T line), coat goat anti-mouse IgG antibody on the quality control line (C line), and fix the colloid Gold binding

anti-SARS-CoV-2 N antigen monoclonal antibody (N antigen-conjugate) gold label pad. After adding a liquid sample to the sample pad, the N

antigen-conjugate is rehydrated and released into the migrating fluid sample. These N-antigen-conjugates can recognize and link N-antigens.

Driven by capillary force, the mixed solution migrates on the T line and the C line to pre-immobilize the capture antibody and goat anti-mouse

IgG antibody, respectively. Subsequently, the agglutination of the conjugate released from the coupling pad, such as the triplet structure of N

antigen-conjugate, N-antigen and capture antibody in a sandwich format, will be captured on the "T line" on the NC membrane. The uncaptured

N antigen-conjugate is recognized by the goat anti-mouse IgG antibody and fixed in the C line. This is an internal control that reflects the

effective release of the N antigen-conjugate from the C line. During detection, when the sample contains the SARS-CoV-2 SARS-CoV-2

antigen and the concentration is higher than or equal to the minimum detection limit, the antibody binds to the antigen marker and is captured by

the second antibody in the detection area (T line) to form a red reaction line. When the red reaction line appears in the area, the result is judged

as positive; when the red reaction line does not appear in the detection area, the result is judged as negative. Under normal testing conditions, the

quality control area (C) should be colored to indicate that the test is valid.