COVID-19 Ag Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of N antigen to SARS-CoV-2 present in human nasal swabs. 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.
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.
1). Test device (individually packed in a foil pouch.)
2). Extraction tube
3). Extraction buffer
4). Sterile swab
5). Instruction for use
Materials Required but not Provided
1. Timer 2. Transfer pipette
Relative sensitivity: 126/133= 94.74% (95%CI 89.53%~97.43%)
Relative specificity: 200/200 >99% (95%CI 98.12%~100%)
Overall agreement: (126+200)/(126+0+7+200)*100%=97.90% (95%CI 95.73%~98.98%)
CI: Confidence Interval