Product Features
The SARS-CoV-2 Antigen Rapid Test is a lateral flow test for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals suspected of COVID-19 within the first seven days of the onset of symptoms. The test can also test specimens from individuals without symptoms.
Performance
Relative Sensitivity: 97.1% (95% CI: 93.1%-98.9%)*
Relative Specificity: 99.5% (95% CI: 98.2%-99.9%)*
Accuracy: 98.8% (95% CI: 97.6%-99.5%)*
*95% Confidence Intervals
Test Highlights
Results in 15 minutes
Nasal swab specimens
Room temperature storage
Excellent performance compared to molecular methods
24 months at 2-30°C
Flowflex™️ SARS-CoV-2 Antigen Rapid Test (Self-Testing)
Operating Instructions
Flowflex™️ SARS-CoV-2 Antigen Rapid Test (Self-Testing)
- Product Specifications
- Feature Specification
- Test Format Cassette
- Specimen Format Anterior nasal swab specimens
- Detects The nucleocapsid protein antigen from SARS-CoV-2
- Sample Volume 4 drops of the prepared specimen
- Relative Sensitivity 97.1% (95% CI: 93.1%-98.9%) 95% Confidence Intervals
- Relative Specificity 99.5% (95% CI: 98.2%-99.9%) 95% Confidence Intervals
- Accuracy 98.8% (95% CI: 97.6%-99.5%） 95% Confidence Intervals
- Test Time 15 minutes
- Shelf Life 24 Months
- Store Temperature 2 – 30 °C
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2#Individual%20EUAs
Emergency Use Authorization ACONlab Flowflex Ag Letter of Authorizations
