COVID-19 Ag Rapid Test Device (NASAL)

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.

Kit Content

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

Performance Characteristics

Clinical Evaluation

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