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FlowFlex

FlowFlex

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Flowflex™ SARS-CoV-2 Antigen Rapid Test

Flowflex 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. Before being approved by CE for self-testing, ACON Flowflex SARS-CoV-2 Antigen Rapid Test was approved for self-testing (layperson use) in multiple European nations in recent months, like Germany, France, Austria, Netherlands, Portugal, Denmark and Czech, making Flowflex SARS-CoV-2 Antigen Rapid Test the most popular antigen test in the self-testing market. 


Test And Approved

The COVID-19 Antigen Rapid Test of FlowFlex is a certified COVID-19 Antigen Rapid Test that has been approved as a CE for self-testing. These kits have been endorsed by the Red Cross in Germany. They are now looking at rolling out into other countries. These are CE marked and can be used in the UK given registered with the above bodies.


Precautions

• Do not eat, drink, smoke or vape 30 minutes prior to or during

the test.

• Do not use the test if any part is damaged.

• All used test materials should be safely disposed of in the

household waste.

• Wash hands thoroughly before and after use.

• Avoid using samples that contain blood.

• Assistance with the swabbing and testing process may be

required by those with hand and vision issues.


Storage and handling

• The test kit should be stored at temperatures between

2 - 30 °C. Do not freeze.

• Do not use the test after the expiration date printed on the

sealed pouch.

• Test should be performed at temperature range 15 - 30 °C.


In your test box you should have: 

• Extraction Buffer Tube Holder

• Test Cassette in sealed pack

• Extraction Buffer Tube in sealed pack

• Waste Bag

• Disposable Swab


Who this test is suitable for?

Adults aged 18+ : Self-test and report, with assistance if needed.

Adolescents aged 12 -17: Self-test and report with adult supervision. The adults may conduct the test, as necessary.

Children under 12: Should be tested by an adult. Do not conduct this test if you do not feel confident testing a child.

 

Results Interpretation 

Positive Results: Coloured bands will appear at both test line (T) and control line (C). This indicates a positive result for the SARS-CoV or SARS-CoV-2 antigens in the specimen.


Negative Results: The coloured band will appear at the control line (C) only. This indicates that the concentration of the SARS-CoV or SARS-CoV-2 antigens does not exist or is below the detection limit of the test.


Invalid Result: No visible coloured band will appear at the control line (C) after performing the test. The directions may not have been followed correctly or the test may have deteriorated. It is recommended that the specimen be re-tested.


The FlowFlex® Rapid Lateral Flow Antigen Test Kit uses the latest patented technology to detect proteins, ensuring that it can detect new strains of the COVID-19 virus. Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test.


Benefits:

• Full Home Test Approval in the UK and EU. 
• We have clinical trials from various countries which show a combined Accuracy: 99.3% (Relative Specificity: 99.6%, Relative Sensitivity: 97.1%)
• U.K. Government validated at Public Health England, Porton Down Laboratories.
• Registered with and CE Marked and ISO certified.
• Available in single packaging or in boxes of 25 to meet your requirements.
 

Specifications:

• Test time: 15 minutes
• Sensitivity:97.1%
• Specificity:99.6%
• CE MARK
• Sample type: Nasopharyngeal swab and oropharyngeal swab
• Quantity: 20 tests/kit

 

Performance:
• Relative Sensitivity: 97.1% (83.8%-99.9%)*
• Relative Specificity: 99.6% (97.7%-99.9%)*
• Accuracy: 99.3% (97.5%-99.9%)*
• *95% Confidence Intervals


Test Highlights:
• Cassette Format
• Detects the nucleocapsid protein antigen from SARS-CoV-2
• Nasal Specimen sample
• Results in 15 minutes
• 2-year shelf Life


The FlowFlex SARS-CoV-2 Antigen Rapid Test 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. Industry-leading accuracy. The UK Government Public Health England, Porton Down Laboratory, which reviews all lateral flow tests for the DHSC/UK Government, has validated our test to have exemplary accuracy at multiple viral loads, including for asymptomatic patients, and across the new different variants.

 

• Nasal swab specimens
• Results in 15 minutes
• Excellent performance compared to molecular methods
• Room temperature storage
 

Box Contains : (Individuals)

Included in the Individuals:

• 1 x Individually sealed test cassettes
• 1 x Individually sealed disposable lower nostril swabs (1-2 cm into the lower nostril)
• 1 x Pre-filled buffer tubes (Huge timesaving & stops wastage of fluid)
• 1 Positive Control Swab
• 1 Negative Control Swab
• 1 Package Insert
• Instructions
 

The easy to use format of the test makes it extremely easy to test with ease.

• Open and use the swab to gently rotate inside the nostril.
• Insert the swab into the buffer tube containing 2 ml of Lysis Solution. 
• Stir the swab in the solution and press to the bottom of the bottle.
• Add 3-4 drops of the solution onto the test card and await result.
 

Product component quality. Our lateral flow test has a unique patented sensitivity enhancement system in our test cassette. Whilst all other cassettes use the colloidal gold method, which is significantly less sensitive for detecting the CoV-SARS-2 antigen. This is in part what allows our test to be so accurate across any specimens and sample collection method.