COIVID-19 Driven Flow™ Antigen Home Test Instructional Video
Feature | Benefit |
Results in 3-7 minutes | Time and cost savings |
Small sample size | Eliminates insufficient sampling issues |
Accelerated, driven flow | Designed to defeat uneven, porous assay components |
Two-step process | Easy-to-use with less potential for procedural errors |
Sealed test cassette | Easy to use and discard |
Internal controls included | Confidence in results due to confirmation of test strip functional integrity |
Room temperature storage | No need for refrigeration or wait times for reagents to warm up. Tests can be run immediately as needed. |
Sample type | Antigen Nasal Swab |
Detects | SAR-CoV-2 |
Time to results | 3-7 minutes |
Kit storage conditions | Room temperature (2°C to 30°C/35.6°F to 86°F) |
Internal controls | Included |
Accuracy | Sensitivity: 88.37% (95% CI: 78.79-97.95%)
Specificity: 99.6% (95% CI: 98.80-100%) Accuracy: 97.93% (95% CI: 96.29 – 95.57%) |
Shelf life | 18 months from date of manufacture |
Available Formats
- One test (for COVID-19 symptomatic use)
- Two tests (serial testing for asymptomatic use)
Driven Flow® Technology
Driven Flow® Technology is a true one-step, three minute test with high accuracy. It is attainable through a tightly restricted sample flow-path with additional flow acceleration, and both forward and downward pressures. These pressures add a strong self-washing function during the flow process, resulting in minimization of non-specific binding in the reaction area. Only the specifically bound antibody-antigen complex remains on the Test line/s through the self-wash process.
Driven Flow® Technology can drastically reduce reaction times, improve the accuracy of the assay, and increase confidence in the specificity of the test.
CE Mark
Currently pending clearance for US sales
Contact us for ordering details
Why test COVID-19 Antigen?
Coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus. Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment, some may become seriously ill and require medical attention. The presence of COVID-19 Antigen indicates that an individual is currently infected with COVID-19 with or without symptoms, who can transmit the virus.
How accurate is this test?
The performance of Driven Flow™ Antigen Home Test was evaluated at the period of 01/25/2022 - 02/22/2022. 290 subjects, who were symptomatic or asymptomatic with contact history within 7 days on the presentation, were enrolled at 5 geographically different sites.
The accuracy of 88.37% positive and 99.60% negative were confirmed by EUA authorized SARS-CoV-2 real time PCR tests. Delta and Omicron variants were both detected by DNA sequencing.
What should I do if test positive?
Report positive result to the healthcare provider and seeking for professional assistances. Isolate the patient at home to limit spreading the virus and follow the instruction of healthcare provider.
What if I test negative?
A negative result indicating that COVID-19 virus is not detected in the specimen tested.
If symptoms continuous, a second or third test is recommended or, and contacting your healthcare provider for advice.
- Negative results, from patients with symptom onset beyond seven days, should be treated as presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed.
- Like other devices, false negative might occur due to the concentration of the COVID-19 virus was below the limits of detection, or the testing is not performed correctly.
How long could I keep the specimen after collection?
- Specimens should be tested as soon as possible after collection