

COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)
Intended Use
The product is intended for the detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.
A recommendation that the kit and analyzer are intended for use by healthcare and laboratory professionals.
For professional use only.
Specifications
Test Item |
Sample |
Sample Volume |
Reaction Time |
Storage Condition |
Shelf Life |
COVID-19 Antigen |
Human nasal swab |
200μL |
15 min |
4℃~30℃ |
18 months |
Main Components
1. COVID-19 Antigen test strip in a sealed pouch with desiccant..................25 tests
2. QR code card for calibration .......................................................................1 piece
3. User Manual ...............................................................................................1 piece
4. Sample Extraction Reagent tube ................................................................1 piece
5. Sample Extraction Vial (Optional) .............................................................25 pieces
6. Nasal Swabs (Optional) .............................................................................25 pieces
Storage And Validity
- Store the test kit at 4℃~30℃ up to the expiration date printed on package.
- Test strip should be used within 1 hour once the foil pouch is opened.
Applicable Device
- LS-1100 Dry Fluorescence Immunoassay Analyzer
- LS-2100 Dry Fluorescence Immunoassay Analyzer
- LS-4000 Dry Fluorescence Immunoassay Analyzer
- LS-3000 Automatic Fluorescence Immunoassay Analyzer