Product data
| Category: | Respiratory Combo Test |
| Manufacturer: | fluorecare |
| SKU: | RT048 |
| EAN: | 6971348761301 |
| Best before: | 11.12.2027 |
| Test method: | Selbsttest (Eigenanwendung),RDT,Schnelltest (RDT),At-home test (self-administered) |
| 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)
- Fast results in 15 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 Covers All Major Respiratory Infections
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. Clinical studies confirm high performance across all four target pathogens with 100% specificity for each analyte.
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 extremely low SARS-CoV-2 limit of detection (LoD) of just 49 TCID50/mL catches infections early, even before symptoms fully develop.
Fast Result in 12 Minutes — Simple Nasal Swab
Comfortable anterior nasal swab at just 2.5 cm depth — suitable for individuals aged 2 and above (children under 14 with adult supervision). Results are available in just 12 minutes. Everything you need is included: test cassette, sterile nasal swab, pre-filled extraction tube with buffer solution, and clear instructions.
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.
Detects All Major SARS-CoV-2 Variants Including Omicron
Based on nucleocapsid protein detection, the fluorecare combo test reliably identifies all major SARS-CoV-2 variants — Alpha, Beta, Gamma, Delta, and Omicron. Extensively validated against over 50 respiratory pathogens and common medications with zero cross-reactivity, ensuring accurate differentiation between COVID-19, flu, and RSV.
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. Current batch expiry: December 2027. 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
The fluorecare 4-in-1 combo test is a must-have for pharmacies during respiratory illness season. Check the volume discount tiers on this page for your best per-test price. Also available in 2-pack and 5-pack configurations. Fast shipping and dedicated B2B support from parahealth — your trusted partner for diagnostics.
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: | 11.12.2027 |
| Test method: | Selbsttest (Eigenanwendung),RDT,Schnelltest (RDT),At-home test (self-administered) |
| 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)
- Please note that the product you have selected is subject to a limitation of the right of return according to Sec. 312g para. 2 no. 3 BGB. As this product is a medical device, returns are excluded for hygiene reasons.
Data sheets & Downloads
B2B inquiry
Bulk order or reseller?
Invoice payment & account manager.
Pharmacies, practices, clinics, institutions, agencies and businesses: dedicated account manager, custom pricing.
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?
We offer a 14-day return policy for private customers. Products must be unused and in original packaging. Please note that B2B and wholesale customers are subject to different terms. Contact our wholesale team for details.
How long does shipping take to Germany?
Standard shipping to Germany takes 1-2 business days from our Berlin facility. We also offer expedited options at checkout for faster delivery.
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?
Yes, we ship worldwide from our Berlin facility. International shipping times vary by destination.
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.