COVID-19 Ag Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 present in human naso-pharynx. This test is for professional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient.
The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.
* Specimen: Nasal Aspiration, Nasal Swabbing, Oropharyngeal Swabbing.
* Rapid test: 15 mins for results
*Convenient storage: 2-30°C
*High sensitivity and specificity
*LOD: 400TCID 50/ml
Principle The COVID-19 Ag Rapid Test Device uses double antibody sandwich immunoassay. The NC membrane pre-immobilized with monoclonal antibodies against SARS-CoV-2 antigen and anti-mouse polyclonal antibodies, and the colloidal-gold conjugated with monoclonal antibodies specific to SARS-CoV-2 antigen. If SARS-CoV-2 antigen present in the sample, a complex formed between the anti-SARS-CoV-2 conjugate and the antigen will be caught by the specific anti- SARS-CoV-2 monoclonal coated on the T region. Results appear in 10 to 20 minutes in the form of a red line that develops on the strip. Whether the sample contains the SARS-CoV-2 antigen 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.
Materials Materials Provided
Test Device (individually packed in a foil pouch)
Sample Collection Tube
Sample Extraction Buffer
Materials Required but not Provided 1. Timer 2. Transfer pipette (for Nasal aspiration collection only)
Relative sensitivity: 129/135= 95.6% (95%CI 93.79%~98.66%)
Relative specificity: 200/200 >99% (95%CI 97.12%~100%)
Overall agreement: (129+200)/(129+0+6+200)*100%=98.21% (95%CI 96.55%~99.36%)
CI: Confidence Interval