Flowflex™ SARS-CoV-2
Antigen Rapid Test Strip (Nasal/Nasopharyngeal)
Flowflex™ SARS-CoV-2 Antigen Rapid Test Strip (Nasal/Nasopharyngeal)
Product Features
The SARS-CoV-2 Antigen Rapid Test Strip is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. The SARS-CoV-2 Antigen Rapid Test Strip can also test specimens from asymptomatic individuals.
Performance
Relative Sensitivity:
Nasal Swab: 97.4% (95% CI: 92.3%-99.5%)
Nasopharyngeal Swab: 97.4% (95% CI: 92.3%-99.5%)
Relative Specificity:
Nasal Swab: 99.8% (95% CI: 98.5%-100.0%)
Nasopharyngeal Swab: 99.8% (95% CI: 98.5%-100.0%
Accuracy:
Nasal Swab: 99.2% (95% CI: 98.0%-99.8%）
Nasopharyngeal Swab: 99.2% (95% CI: 98.0%-99.8%)
Test Highlights
Nasal and Nasopharyngeal swab specimens
Results in 15 minutes
Excellent performance compared to molecular methods
Room temperature storage
Flowflex™ SARS-CoV-2 Antigen Rapid Test Strip (Nasal/Nasopharyngeal)
Operating Instructions
Flowflex™ SARS-CoV-2 Antigen Rapid Test Strip (Nasal/Nasopharyngeal)
Product Specifications
| Feature | Specification |
| Test Format | Strip |
| Specimen Format | Nasal swab specimens and Nasopharyngeal swab specimens |
| Detects | The nucleocapsid protein antigen from SARS-CoV-2 |
| Relative Sensitivity | Nasal Swab: 97.4% (95% CI: 92.3%-99.5%) Nasopharyngeal Swab: 97.4% (95% CI: 92.3%-99.5%) |
| Relative Specificity | Nasal Swab: 99.8% (95% CI: 98.5%-100.0%) Nasopharyngeal Swab: 99.8% (95% CI: 98.5%-100.0%) |
| Accuracy | Nasal Swab: 99.2% (95% CI: 98.0%-99.8%） Nasopharyngeal Swab: 99.2% (95% CI: 98.0%-99.8%) |
| Test Time | 15 minutes |
| Shelf Life | 24 Months |
| Store Temperature | 2 – 30 °C |
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