Rapid SARS-CoV-2 Antigen Test Card
- Self-test received notified body approved CE marking on April 1, 2021
- FDA grants EUA for Rapid SARS-CoV-2 Antigen Test Card (Home Test) on April 6 2022
- A home test for the rapid qualitative detection of SARS-CoV-2 virus antigen in anterior nasal swabs within 7 days of symptom onset
Product Information
Performance Characteristics
- Sample type: nasal swab
- Time to result: 15-20 min
- Sensitivity: 96.77%
Specificity: 99.20%
Accuracy: 98.72% - Layperson study statistics:
- 99.10% of non-professionals carried out the test without requiring assistance
- 97.87% of different types of results were interpreted correctly
- Clinical study finished by Tricore Reference Laboratories and has met the requirement of FDA EUA
- Multiple variants can be accurately detected, including Delta and Omicron
Specifications
Various packaging specifications available:
- 1 Test/Kit
- 2 Tests/Kit
- 4 Tests/Kit
- 5 Tests/Kit
- 8 Tests/Kit
- 10 Tests/Kit
- 20 Tests/Kit
- 40 Tests/Kit
Components contained:
- Test Card in sealed pouch
- Pre-filled buffer
- Sterilized swab
- Tube holder (1/2 Tests/Kit on packaging)
- Quick Reference Instructions
Box/Carton Specifications
| 1 Test/Kit | 2 Tests/Kit | 4 Tests/Kit | 5 Tests/Kit | |
|---|---|---|---|---|
| Box Size | 155*60*15mm | 155*60*17mm | 155*60*32mm | 155*60*37mm |
| Carton Size | 335*420*350mm | 335*470*350mm | 335*335*350mm | 335*410*350mm |
| Gross Weight | 7.8kg 250 tests (250 boxes)/carton | 10.0kg 500 tests (250 boxes)/carton | 6.9kg 400 tests (100 boxes)/carton | 8.3kg 500 tests (100 boxes)/carton |
| 8 Tests/Kit | 10 Tests/Kit | 20 Tests/Kit | 40 Tests/Kit | |
|---|---|---|---|---|
| Box Size | 155*60*50mm | 155*60*60mm | 155*120*60mm | 205*145*65mm |
| Carton Size | 335*550*350mm | 335*650*350mm | 335*640*350mm | 435*615*375mm |
| Gross Weight | 12.6kg 800 tests (100 boxes)/carton | 14.5kg 1000 tests (100 boxes)/carton | 14.5kg 1000 tests (50 boxes)/carton | 19.6kg 1600 tests (40 boxes)/carton |