INTENDEDUSE
The SARS-CoV-2 antigen IVD kit SWAB is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in human swab, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronvirus antigen. It will provide information for clinical doctors to prescribe correct medications.
SUMMARY
The novel coronaviruses belong to the β genus.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.
PRINCIPLE
The SARS-CoV-2 antigen IVD kit SWAB is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to Novel coroinavirus.
The test strip is composed of the following three parts, namely sample pad, reagent pad and reaction membrane. The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coroinavirus; the reaction membrane contains the secondary antibodies for Novel coroinavirus, and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane.
When the test device was inserted into saliva sample,conjugates dried in the reagent pad are dissolved and migrate along with the sample. If Novel coroinavirus is present in the sample, a complex formed between the anti- Novel coroinavirus conjugate and the virus will be caught by the specific anti- Novel coroinavirus monoclonal coated on the T region.
Whether the sample contains the virus or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C.
The SARS-CoV-2 antigen IVD kit SWAB product can detect SARS-Cov-2 nucleo-protein(mainly) and spike protein.
More than 90% antibody used in SARS-CoV-2 antigen IVD kit SWAB is anti-nucleoprotein of SARS-Cov-2 and target protein is SARS-Cov-2 nucleoprotein.
The rest antibody used in SARS-CoV-2 antigen IVD kit SWAB is anti-Spike protein and target protein is SARS-Cov-2 Constant fragment of Spike protein.
At present, whether the N501Y in the United Kingdom or the 501Y.V2 in South Africa, the variant fragments are mainly the RBD fragment of the S protein, and the target fragments of the antibodies used inNovel Coronavirus SARS-CoV-2 antigen IVD kit SWAB have not been mutated.So,The SARS-CoV-2 antigen IVD kit SWAB can reliably detect the SARS-Cov-2 variants.
So,The SARS-CoV-2 antigen IVD kit SWAB can reliably detect the nucleo-protein and spike protein of genetic SARS-Cov-2 variants.
