Description
The Flowflex SARS-CoV-2 Antigen Rapid Lateral FlowTest is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of an active COVID-19 infection by their healthcare provider within the first seven days of the onset of symptoms.
- Supplied in a single pack
- Cassette Format
- Detects the nucleocapsid protein antigen from SARS-CoV-2
- Nasal Specimen sample. Anterior Nares Only Test (2-4cm inside the nostril)
- Results in 15 minutes
- CE Marked for Self Test
- Used by NHS track and trace as a home test
- Unique ID QR code number on each cassette
Pack Contents
- 1 x Test Cassette with QR code and unique ID number
- 1 x Extraction Buffer Tube
- 1 x Disposable Swab
- 1 x Waste Bag
- 1 x Package Insert
Features:
- Fully Home Use Approved
- FDA Approved
- Validation from Public Health England Porton Down.
- Full Home Test Approval Granted in the UK & EU
- Registered with MHRA and CE Marked.
- Used and trusted by companies around the world including all UK airports and the NHS.
Detailed Technical Information -
Feature Specification
Test Format
Cassette
Specimen Format
Nasal Swab
Detects
The nucleocapsid protein antigen from SARS-CoV-2
Sample Volume
4 to 5 drops of the prepared specimen
Relative Sensitivity
97.1% (83.8%-99.9%) 95% Confidence Intervals
Relative Specificity
99.6% (97.7%-99.9%) 95% Confidence Intervals
Accuracy
99.3% (97.5%-99.9%) 95% Confidence Intervals
LOD
1.6*102 TCID50/mL
Test Time
15 minutes
Shelf Life
24 Months
Store Temperature
2 – 30 °C