Product data
| Category: | Respiratory Combo Test |
| Manufacturer: | fluorecare |
| SKU: | RT048 |
| EAN: | 6971348761301 |
| Best before: | 31.01.2028 |
| Test method: | At-home test (self-administered),RDT |
| Sample type: | Abstrich |
| IFU languages: | ENDEESITPL |
| HSC-ID: | 1967 |
| PZN: | 19205851 |
fluorecare Corona & Influenza A/B & RSV Antigen Combo Test
Benefits:
- Multi-pathogen detection (4 tests in 1)
- Read results after 12 minutes
- CE certified medical device
- No laboratory required
- High sensitivity and specificity
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Description
fluorecare 4-in-1 Combo Rapid Test: COVID-19, Influenza A/B & RSV
One test, four answers. The fluorecare SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit detects COVID-19, Influenza A, Influenza B, and RSV from a single nasal swab: individually packaged for maximum flexibility. CE-certified (CE 2934) and designed for reliable home screening during cold and flu season.
4-in-1 Detection: One Swab Targets Four Respiratory Pathogens
Why run separate tests when one does it all? The fluorecare combo test differentiates between SARS-CoV-2, Influenza A, Influenza B, and RSV in a single cassette using colloidal gold immunochromatography. Each pathogen has its own clearly marked result line: no guesswork. In the clinical evaluation reported in the instructions for use, specificity was 100% for each of the four analytes.
Clinically Validated: High Accuracy Across All 4 Pathogens
Tested on 818 subjects for COVID-19 and 668 for Influenza/RSV, the fluorecare combo delivers reliable results across all targets:
- COVID-19: 92.93% sensitivity (99.05% at Ct≤25), 100% specificity, 96.82% overall accuracy
- Influenza A: 92.04% sensitivity, 100% specificity, 98.65% overall accuracy
- Influenza B: 90.91% sensitivity, 100% specificity, 98.80% overall accuracy
- RSV: 95.45% sensitivity, 100% specificity, 99.55% overall accuracy
The SARS-CoV-2 limit of detection (LoD) stated in the instructions for use is 49 TCID50/mL.
Read the Result After 12 Minutes: Simple Nasal Swab
Anterior nasal swab at a depth of 2.5 cm. The instructions for use specify use from 2 years of age. For persons aged 2–14, sample collection and testing should be performed by adults or parents aged 18–60. Persons aged 14–17 may collect samples and perform the test under the supervision of adults or parents aged 18–60. Read the result after 12 minutes; do not read it after 20 minutes. The kit includes the test cassette, sterile nasal swab, pre-filled extraction tube with buffer solution, and instructions for use.
How to Perform the fluorecare 4-in-1 Test
Open the extraction tube and remove the blue stopper. Insert the sterile nasal swab 2.5 cm into each nostril and rotate 5 times against the nasal wall. Place the swab into the extraction tube, break at the score line, and secure the cap. Squeeze the swab 10 times, wait 1 minute, then apply 2 drops per sample well on the test cassette. Read results after 12 minutes (do not read after 20 minutes). Each pathogen has a separate detection line: you can test for all four simultaneously or individually.
SARS-CoV-2 Nucleocapsid Antigen Detection
The test detects the SARS-CoV-2 nucleocapsid antigen. The instructions for use list Alpha, Beta, Gamma, Delta, and Omicron among the identifiable SARS-CoV-2 variants and report cross-reactivity and interference testing for the organisms and substances listed there.
Package Contents
- 1x individually sealed test cassette with desiccant
- 1x sterile anterior nasal swab
- 1x pre-filled extraction tube with buffer solution (0.5 mL normal saline)
- 1x instruction for use (EN, DE, ES, IT, PL)
Storage & Shelf Life
Store at 2-30 degrees C in a dry place, protected from light. Do not freeze. Test kit validity: 24 months from manufacture. For the current batch expiry date, see the expiry information shown near the price. Once the foil pouch is opened, use the test within 1 hour. Perform the test at room temperature (20-25 degrees C).
Bulk Orders for Pharmacies & Healthcare Providers
This product is supplied as a pack containing 1 test. For larger orders, use the quantity selector and consult the current volume pricing on this page.
Regulatory Information
Manufactured by Shenzhen Microprofit Biotech Co., Ltd. CE-marked under IVD Directive 98/79/EC. Notified Body: CE 2934. EC Representative: CMC Medical Devices & Drugs, S.L. (Malaga, Spain). For in vitro diagnostic use only. For self-testing use. PZN: 19205851. REF: MF-71.
Product data
| Category: | Respiratory Combo Test |
| Manufacturer: | fluorecare |
| SKU: | RT048 |
| EAN: | 6971348761301 |
| Best before: | 31.01.2028 |
| Test method: | At-home test (self-administered),RDT |
| Sample type: | Abstrich |
| IFU languages: | ENDEESITPL |
| HSC-ID: | 1967 |
| PZN: | 19205851 |
Regulatory notices
- CE-certified in-vitro diagnostic (IVD)
- Intended for self-testing by lay users
- For single use only
- Read instructions carefully before use
- Store at room temperature (2-30 degC)
- For sealed goods that cannot be returned for health protection or hygiene reasons, the statutory right of withdrawal does not apply if the hygiene seal has been removed after delivery. We do not offer voluntary returns for tests beyond your statutory rights. Your statutory rights concerning defective goods remain unaffected. Please see our return policy for details.
Data sheets & Downloads
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B2B inquiry
Bulk order or reseller?
Invoice payment & account manager.
Pharmacies, practices, clinics, institutions, agencies and businesses: dedicated account manager, custom pricing.
Or email us directly at sales@parahealth.de
Frequently asked questions
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What does the fluorecare 4in1 Combo Test detect?
How accurate is the fluorecare 4in1 rapid test?
How long does it take to get results?
Can children use the fluorecare 4in1 test?
Which COVID-19 variants does the test detect?
What pack sizes are available and are bulk orders possible?
Frequently asked questions about parahealth
Find answers to the most common questions about ordering, shipping, and our products.
Are your products clinically tested and safe?
Yes, all our medical devices and diagnostic tests undergo rigorous clinical testing and validation to ensure safety, accuracy, and efficacy. We comply with all relevant medical device regulations and quality standards.
What is your return policy?
Consumers have the statutory right of withdrawal described in our return policy. For sealed goods that are unsuitable for return for health protection or hygiene reasons, this right does not apply if the hygiene seal has been removed after delivery. We do not offer voluntary returns for tests beyond statutory rights. For other medical supplies, we assess voluntary return requests individually; items must be unused and any hygiene seals must be intact. Business customers have no statutory consumer right of withdrawal; voluntary returns of other medical supplies require an individual agreement. Statutory rights concerning defective goods remain unaffected.
How long does shipping take to Germany?
Estimated total delivery time to Germany is 1–3 business days, including order processing. Shipping costs and available delivery methods are shown at checkout.
Do you provide support for professional/clinical use?
Yes, we offer dedicated support for healthcare professionals and clinics, including product training and technical assistance.
What are your B2B payment and shipping terms?
B2B customers receive customized payment terms and shipping arrangements. Please contact our wholesale team for details.
Do you offer bulk orders or wholesale pricing?
Yes, we offer B2B wholesale pricing for pharmacies, clinics, and medical practices. Contact us for volume pricing and terms.
Will I receive tracking information?
Yes, all orders include tracking information sent via email so you can monitor your shipment.
Do you ship internationally?
We ship to the destinations available at checkout. Estimated total delivery times are 5–11 business days elsewhere in Europe and 4–12 business days outside Europe. Shipping costs are calculated at checkout.
Where do you ship from?
We ship from our state-of-the-art AutoStore Warehouse in Berlin, Germany, ensuring fast and efficient order processing and delivery.