Rapid Antigen Test FlowFlex

Features: 

• Very Highest Sensitivity rating by TGA (ARTG Identifier 382031)
• Detects the nucleocapsid protein antigen from SARS-CoV-2
• Full Home Test Approval Granted in the UK & EU.
• Used and trusted by companies around the world including all UK airports and the NHS.
• Registered with MHRA & CE approved and ISO certified.
• Specimen Format: Nasal Swab
• Results in 15 minutes
• Antigen Home Testing Kit
• Cassette Format
• Option to test at home and upload your test results. Test Results Certificate is then sent to you electronically via email
• Single-use only
• Fully Home Use Approved Detects New Virus Strains including Indian Variant MHRA Registered 

The Covid-19 Rapid Antigen Test FlowFlex detects the presence of protein on the surface of SARS-CoV-2 Virus in nasal swab specimens directly from individuals who are suspected of an active COVID-19 infection. The Covid-19 Rapid Lateral Flow Antigen Test works by mixing the sample with a solution that unleashes the specific viral protein and the buffer solution is dispensed on the cassette which will show a positive or negative test result based on the line shown on the control and test line. The Covid-19 RAT - FlowFlex lateral flow test works rapidly and test result can be interpreted within 15 to 30 minutes. Covid-19 Rapid Antigen Test - FlowFlex is fully Home Use Approved.

The FlowFlex Rapid Antigen Test Kits that we use are suitable for fit to fly purpose and general testing in some destination countries. 

The test kits are also CE certified for self-testing and approved by the UK government, MHRA registered and listed in the EU Commission Directorate-General For Health Food and Safety; the test is currently supplied to The UK, German, Austrian, French and Spanish Governments and all UK airports.

Each Covid-19 Rapid Antigen Test - FlowFlex Nasal Swab Testing Kit contains:

• 1 x Test Cassette
• 1 x Extraction Buffer Tube
• 1 x Disposable Swab
• 1 x Waste Bag

Technical Specification:

• Brand: ACON
• Test Format: Cassette
• Nasal Specimen sample. Anterior Nares Only Test (2-4cm inside the nostril)
• Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer.
• 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
• EXP 29/4/23

Interpretation of Results:

TGA Post-market review of Rapid Antigen Test FlowFlex

Statement On The Omicron Variant

Dec 10, 2021

We at ACON Laboratories, Inc. have been continuously monitoring the emergence of SARS-CoV-2 variants and the Omicron variant is no exception.

The Omicron variant is notable for the significant number of mutations in the Spike protein. Those mutations are not relevant to the Flowflex™ COVID-19 Antigen Home Test, which detects the SARS-CoV-2 Nucleocapsid protein.

According to the GISAID analysis and the pairwise sequence alignment comparison of the Nucleocapsid protein from all of the tested variants (B.1.351, B.1.1.7, P.1, and Delta variant B.1.617.2), there is a high likelihood that the SARS-CoV-2 Omicron Variant (lineage B.1.1.529) is detectable by the Flowflex COVID-19 Antigen Home Test.

We anticipate testing virus samples, once they become available to us, to further verify the performance of our test in detecting the Omicron Variant.

Furthermore, ACON will continue to monitor the evolution of COVID-19 variants in circulation worldwide and evaluate the performance of our assays against Omicron and future variants to maintain the high level of product performance our customers have come to rely upon.

Sincerely,

Michael Lynch
Vice President, Sales and Marketing

Acon's statement on Omicron (B.1.1.529) variant to view the document CLICK HERE