fluorecare 4in1 Combo SARS-CoV-2, Influenza A/B & RSV Antigen Rapid Test | 25 Tests | Professional Use

For healthcare professionals only. This product is intended exclusively for professional use in medical practices, hospitals and healthcare facilities. Not for self-testing. Sold to healthcare professionals only.

fluorecare SARS-CoV-2, Influenza A/B & RSV Antigen Combo Rapid Test, 25 Tests

Differential diagnosis of acute respiratory infections at the point of care: one nasal swab, four pathogens, results in 15 minutes.

Fever, cough, runny nose: COVID-19, influenza and RSV infections are often clinically indistinguishable. The fluorecare combo rapid test qualitatively detects and differentiates SARS-CoV-2, Influenza A, Influenza B and RSV antigens in nasal swab specimens. This gives you a sound basis for treatment decisions, isolation measures and further diagnostics while the patient is still in the consultation.

Each test cassette has three separate sample wells for SARS-CoV-2, Influenza A/B and RSV. Depending on the clinical question, you can test for all pathogens at once or for individual ones only. The 25-test pack is designed for routine use in practices and hospitals.

Areas of use

• General practices and paediatric practices
• ENT and internal medicine practices
• Emergency departments and out-of-hours services
• Hospitals and outpatient clinics
• Care facilities and occupational health services

Key benefits

• Multiplex detection: SARS-CoV-2, Influenza A, Influenza B and RSV from a single specimen
• Fast clinical decisions: results in 15 minutes, no instrument required
• High specificity: 100 % for all four pathogens in the manufacturer's clinical study
• High sensitivity at high viral load: 99.05 % positive agreement for SARS-CoV-2 at Ct < 25
• Variant coverage: detects the SARS-CoV-2 nucleocapsid protein, tested with Alpha, Beta, Gamma, Delta and Omicron
• No cross-reactivity between the four target pathogens or with a broad panel of other respiratory pathogens
• Flexible: use all three sample wells or individual ones only
• Efficient workflow: prefilled extraction tubes, no pipetting
• Easy storage: no cold chain required, 2 to 30 °C
• Broad patient range: suitable for patients aged 2 years and older
• Cost-efficient: 25 tests per pack
• CE-marked in vitro diagnostic medical device

Test procedure (overview)

1. Bring the test kit and specimens to room temperature (20 to 25 °C). If taken from the refrigerator, allow 5 minutes to equilibrate.
2. Twist off the cap of the extraction tube, remove the blue inner stopper and place the tube in the holder.
3. Insert the sterile swab approx. 2.5 cm into one nostril and rotate it 5 times against the nasal mucosa. Repeat in the other nostril using the same swab.
4. Squeeze the swab 10 times in the tube, break it at the breakpoint, close the tube and incubate for 1 minute.
5. Open the dropper cap and add 2 drops (approx. 60 µl) to each required sample well (S).
6. Read the result after 15 minutes. Results read after more than 20 minutes are invalid.

Always follow the instructions for use supplied with the product.

Interpretation of results

Any visible test line, regardless of intensity, indicates a positive result.

Clinical performance (manufacturer data)

SARS-CoV-2: positive agreement by Ct value

Negative percent agreement (NPA): 100 %.

Analytical performance

Cross-reactivity: No cross-reactivity between the four target pathogens or with an extensive panel of other organisms, including human coronaviruses (OC43, 229E, NL63, HKU1, MERS), adenoviruses, enterovirus 68, human metapneumoviruses, parainfluenza viruses types 1 to 4, rhinovirus, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Bordetella pertussis, Legionella pneumophila, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Pseudomonas aeruginosa and Candida albicans.

Interference: No interference from substances including whole blood (5 %), mucin, decongestant nasal sprays (oxymetazoline, phenylephrine), cromolyn, fluticasone, budesonide, dexamethasone, oseltamivir, tobramycin, mupirocin, benzocaine, acetylsalicylic acid, diphenhydramine, dextromethorphan and biotin.

Repeatability: 100 % positive agreement across 10 replicate measurements.

Technical specifications

Contents

• 25 × test cassette with desiccant, individually sealed in a foil pouch
• 25 × sterile nasal swab
• 25 × prefilled extraction tube (0.5 ml buffer solution each)
• Instructions for use

Also required: timer.

Important information

• For in vitro diagnostic use by healthcare professionals only. Not for self-testing.
• Always interpret test results in conjunction with patient history, clinical presentation and other findings. A diagnosis must be made by a physician.
• A negative result does not rule out infection, for example if antigen levels are below the limit of detection or the specimen was collected improperly. Further diagnostics are indicated where clinical suspicion persists.
• For single use only. Do not interchange components from different lots.
• Do not use after the expiry date or if the foil pouch is damaged.
• Do not touch the reaction area of the test cassette. Avoid contact of the buffer solution with eyes and skin.
• Treat specimens and used test components as potentially infectious and dispose of them in accordance with local regulations.
• Read the instructions for use completely before performing the test.