Flowflex Lateral Flow Test SARS CoV 2 Antigen Rapid 25 Tests
Flowflex
Infection ControlCOVID-19 Rapid Antigen Lateral Flow Test Kit
Certifications
- CE marked for self Testing (IVD) within the UK and EU.
- Registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for self Test distribution.
- UK Government validated, including evaluation at Porton Down and Oxford (PHE 3a clinical trial).
- Manufactured under ISO 13485–compliant quality management system.
- Meets EN ISO and EU regulatory requirements for in vitro diagnostic medical devices for SARS CoV 2 antigen testing.
- Performance independently evaluated in external studies (e.g. FIND / WHO collaborating evaluations) demonstrating high sensitivity and specificity.
- CE marked for self Testing (IVD) within the UK and EU.
- Registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for self Test distribution.
- UK Government validated, including evaluation at Porton Down and Oxford (PHE 3a clinical trial).
- Manufactured under ISO 13485–compliant quality management system.
- Meets EN ISO and EU regulatory requirements for in vitro diagnostic medical devices for SARS CoV 2 antigen testing.
- Performance independently evaluated in external studies (e.g. FIND / WHO collaborating evaluations) demonstrating high sensitivity and specificity.
COVID-19 Rapid Antigen Lateral Flow Test Kit
Description
The Flowflex Lateral Flow Test SARS-CoV-2 Antigen Rapid - 25 Tests is a CE-marked, UK Government–validated rapid antigen lateral flow test kit for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens. Each kit contains 25 cassette-format tests with English self-test instructions and prefilled extraction buffer tubes. The test provides results in 15 minutes and is intended to aid in the identification of individuals suspected of having an active COVID-19 infection by their healthcare provider within the first seven days of the onset of symptoms, and can also be used for asymptomatic screening. Manufactured by Acon Biotech (Hangzhou) Co., Ltd., the same manufacturer that produced the lateral flow tests distributed by the UK Government, the Flowflex SARS-CoV-2 Antigen Rapid Test has demonstrated high performance in independent evaluations, including validation at Porton Down and Oxford (PHE 3a clinical trial).
Bnefits
- Rapid results in approximately 15 minutes, enabling quick decision-making and isolation where necessary.
- Qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen using anterior nasal (lower nostril) swab specimens.
- Cassette-format lateral flow chromatographic immunoassay that is simple to use at the point of care or for supervised self-testing.
- High diagnostic performance with relative sensitivity around 97.1%, relative specificity around 99.6% and overall accuracy around 99.3% (95% confidence intervals).
- CE marked and ISO-certified manufacturing, with UK Government validation and MHRA registration for self-test use.
- Room-temperature storage (2–30°C) and up to 24-month shelf life from manufacture, improving logistics and stock management.
- Includes all key components required to perform 25 tests (test cassettes, extraction buffer tubes, swabs, waste bags, tube holder and instructions).
- Targets anterior nasal swab only (lower nostril), which is generally more comfortable than nasopharyngeal sampling.
- Validated at Public Health England Porton Down and Oxford 3a clinical trial for performance against reference PCR testing.
- Supplied via approved UK importers and recognised distributors such as Medisave, St John Ambulance and others.
Indications
- In vitro diagnostic use for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal (lower nostril) swab specimens.
- Provides an aid in identifying individuals suspected of an active COVID-19 infection by their healthcare provider within the first seven (7) days of the onset of symptoms.
- Can be used to test individuals with or without symptoms where rapid antigen testing is appropriate, following local public health guidance.
- Self-testing (lay-user) use under national authorisations, with English instructions included for home use or supervised testing.
- Suitable for use in healthcare, workplace, educational and community screening programmes where CE-marked self-tests are accepted.
Composition
- Analyte detected: SARS-CoV-2 nucleocapsid protein antigen (N protein).
- Test cassette containing immobilised anti–SARS-CoV-2 antibodies on a nitrocellulose membrane and colloidal gold–labelled antibodies in the conjugate pad.
- Extraction buffer tubes prefilled with proprietary buffer solution containing surfactants and preservatives (e.g. Triton X-100 and sodium azide in low concentrations, as per IFU).
- Sterile anterior nasal swabs for sample collection (lower nostril).
- Positive control swab containing recombinant SARS-CoV-2 antigen (in some professional-use 25-test configurations).
- Negative control swab (in professional-use 25-test configurations).
- Waste bags and tube holder for safe handling and disposal of test components.
Formulation
- Lateral flow chromatographic immunoassay (cassette format) for qualitative detection of SARS-CoV-2 antigen.
- Specimen type: anterior nasal swab (lower nostril); some professional configurations also validated for nasopharyngeal swabs.
- Test time: read results at 15 minutes (do not read before 15 minutes or after 30 minutes, as per IFU).
- Performance (self-test / nasal use): relative sensitivity approximately 97.1% (95% CI typically reported between ~83.8%–99.9% in UK validation summaries), relative specificity approximately 99.6% (95% CI 97.7%–99.9%), and accuracy approximately 99.3% (95% CI 97.5%–99.9%).
- Storage: 2–30°C (room temperature), do not freeze; stable for up to 24 months from date of manufacture when stored in sealed pouches.
- Intended users: lay users (self-test) or healthcare professionals, depending on local authorisation and kit labelling (self-testing CE configuration for Europe/UK).
Packaging
- One box containing 25 Flowflex SARS-CoV-2 Antigen Rapid Test cassettes (self-test configuration).
- Typical kit contents (25-test self-test configuration): 25 test cassettes, 25 prefilled extraction buffer tubes, 25 disposable nasal swabs, 25 waste bags, 1 tube holder, 1 package insert with English instructions.
- Individually sealed foil pouches for each test cassette with desiccant and printed expiry date/lot number.
- Outer retail carton labelled with brand (Flowflex), product name, CE mark, self-test designation, lot number, expiry date and storage conditions.
- Distributors may supply in original manufacturer cartons, sometimes in outer shipping cases containing multiple 25-test boxes.
Usage
- Check kit contents and verify that all components are present, the pouch is intact and the test is within its expiry date.
- Allow the kit components to reach room temperature (within 15–30°C) before use.
- Blow your nose and wash or sanitise hands thoroughly before sample collection.
- Open the foil pouch immediately before testing and place the test cassette on a flat, clean surface.
- Insert the prefilled extraction buffer tube into the tube holder to prevent spillage.
- Open the swab package at the stick end and remove the sterile swab, taking care not to touch the fabric tip.
- Tilt the head slightly back and gently insert the entire fabric tip of the swab into one nostril (anterior nasal sampling, typically up to 2.5 cm inside the nostril).
- Rotate the swab inside the nostril at least 5 times, ensuring good contact with the nasal wall.
- Using the same swab, repeat the process in the other nostril with at least 5 gentle rotations.
- Insert the swab into the extraction buffer tube, swirl for at least 30 seconds and rotate the swab at least 5 times while squeezing the tube walls to extract the antigen into the buffer.
- Remove the swab while squeezing the sides of the tube to expel liquid from the swab tip, then discard the swab in the waste bag.
- Fit the dropper cap onto the extraction buffer tube securely.
- Add the specified number of drops (typically 4) of processed specimen into the sample well (S) of the test cassette.
- Start a timer and read the result at 15 minutes; do not interpret results after 30 minutes.
- Interpretation: one line at the control region (C) only = negative; two lines (C and T) = positive; no control line (C) = invalid (repeat test with a new cassette).
- Dispose of all used components (test cassette, swab, tube, buffer, waste bag) according to local regulations for clinical or household infectious waste.
- Follow local public health and medical guidance regarding isolation, confirmatory testing and clinical care based on the test result.
Contraindications
- Not intended as the sole basis for diagnosis of SARS-CoV-2 infection; results should be considered in conjunction with clinical evaluation and other laboratory findings.
- Negative results in individuals with symptoms lasting more than 7 days should be considered presumptive and confirmed by molecular (PCR) testing where indicated.
- Not validated for specimen types other than anterior nasal (lower nostril) swabs (and, in professional configurations, nasopharyngeal swabs).
- Do not use the test on individuals who have had recent severe facial or head trauma or surgery, or who are prone to significant nosebleeds, without medical advice.
- Do not use the test after the expiry date or if the foil pouch is damaged or has been open for more than the time specified in the IFU.
- Do not reuse test components; single-use only.
- Not suitable for use in children below the minimum age specified in local self-test guidance without appropriate adult collection or supervision.
Adverse Effects
- Temporary discomfort, tickling or minor pain in the nose during swab insertion and rotation.
- Possible transient sneezing or watery eyes following nasal swab collection.
- In rare cases, minor nosebleeds (epistaxis), particularly in individuals with fragile nasal mucosa or clotting disorders.
- Potential allergic or irritation reactions to buffer reagents in the unlikely event of skin or eye contact (e.g. irritation from surfactants or preservatives); users should avoid contact with buffer and rinse thoroughly if exposure occurs.
Storage Conditions
- Store the unopened kit at 2–30°C (room temperature) in a dry place, away from direct sunlight and moisture.
- Do not freeze the kit or any of its components.
- Keep test cassettes in their sealed foil pouches until immediately before use.
- Observe the expiry date printed on each pouch and the outer carton; do not use expired tests.
- Once a foil pouch is opened, perform the test within the time frame specified in the IFU (typically within one hour) to avoid deterioration.
- Store out of reach of children when not in use.
