

Product data
| Category: | COVID-19 Antigen Test |
| Manufacturer: | Hotgen |
| SKU: | RT009 |
| EAN: | 6970297534073 |
| Best before: | 30.09.2026 |
| Test method: | Schnelltest (RDT),Selbsttest (Eigenanwendung) |
| Sample type: | Abstrich |
| IFU languages: | ENDEFRITESPT |
| PZN: | 8105940 |
Hotgen Corona Antigen Rapid Test (Colloidal Gold) for Home Use Nasal
Benefits:
- Easy self-testing at home
- Fast results in 15 minutes
- CE certified medical device
- No laboratory required
- Simple nasal swab collection
- High sensitivity and specificity
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Description
Hotgen Corona Antigen Rapid Test — Germany's Most Trusted COVID-19 Self-Test
The Hotgen Coronavirus (2019-nCoV) Antigen Rapid Test is one of the most widely used and recognised COVID-19 self-tests in Germany and across Europe. CE-certified by TÜV (CE 0123), PEI-evaluated, and BfArM-listed — this test has become synonymous with reliable SARS-CoV-2 detection. Each test is individually packaged with everything you need for a fast, accurate result in just 15 minutes. At parahealth, you buy individually — pick exactly the quantity you need and benefit from volume pricing starting at just €0.23 per test.
How the Hotgen Corona Test Works
The Hotgen COVID-19 test uses colloidal gold immunochromatographic technology with a double-antibody sandwich method targeting the SARS-CoV-2 N-protein. When the SARS-CoV-2 antigen in the sample binds to colloidal gold-labelled antibodies, it forms a complex that migrates along the test strip. A visible coloured line at the T-position indicates a positive result, while the C-line confirms the test has worked correctly.
The test procedure is straightforward: gently insert the swab 1.5 cm into each nostril, rotate 4–6 times for at least 15 seconds, then place the swab into the pre-filled extraction buffer tube. After squeezing and mixing, apply 4 drops to the test cassette and read the result after 15 minutes. Results should not be read after 30 minutes.
Clinical Performance & Accuracy
The Hotgen Corona Antigen Rapid Test has been extensively validated in clinical studies:
- Diagnostic sensitivity: 97.51% (520/533 confirmed positive samples)
- Diagnostic specificity: 100% (325/325 confirmed negative samples)
- Overall agreement with RT-PCR: 98.48%
Reproducibility studies showed 100% agreement across different operators and testing days. The test is validated for use within the first 7 days of symptom onset and can also detect infections in asymptomatic individuals, though sensitivity may be lower when viral loads are very low.
No Cross-Reactivity — Validated Against 40+ Pathogens
The Hotgen test has been tested against more than 40 respiratory viruses, bacteria, and fungi with no cross-reactivity detected. This includes all common coronaviruses (HCoV-229E, OC43, NL63, HKU1), Influenza A subtypes (H1N1, H3N2, H5N1, H7N9), Influenza B, RSV, Adenovirus, Parainfluenza, Rhinovirus, MERS-CoV, Mycoplasma pneumoniae, Streptococcus, Bordetella pertussis, and many more. Additionally, no interference was found with over 25 common medications and endogenous substances.
What's Included — Each Test Contains
- 1× SARS-CoV-2 antigen test cassette
- 1× sterile nasal swab (individually sealed)
- 1× sample extraction buffer tube (pre-filled)
- 1× biohazard specimen bag
- 1× multilingual instruction leaflet (DE, EN, FR, IT, ES, PT)
Every test is individually foil-sealed for maximum shelf life and hygienic single use. This makes it ideal for distribution in pharmacies, workplaces, and institutional settings where individual packaging is required.
Who Is This Test For?
The Hotgen COVID-19 self-test is designed for home use by individuals aged 18 and over. Children and young people under 18 may use the test under adult supervision. Common use cases include:
- Households & families: Quick testing when symptoms appear — cough, sore throat, fever, loss of taste or smell
- Before visiting vulnerable people: Test before visiting elderly relatives, nursing homes, or hospitals
- Workplaces & offices: Regular screening for employees with customer contact
- Events & gatherings: Pre-event testing for concerts, conferences, family celebrations
- Travel: Some destinations still require negative COVID tests for entry
- Schools & childcare: Gentle nasal swab at just 1.5 cm depth makes it suitable for supervised testing of children
Storage & Shelf Life
Store at 2–30°C (room temperature). The sealed test cassettes have a shelf life of 36 months from the date of manufacture. Once the aluminium foil pouch is opened, the test must be used within 30 minutes. The extraction buffer tube, once opened, should be used within 2 hours at room temperature or within 2 months if refrigerated at 2–8°C. Always check the expiry date printed on the packaging before use.
Certifications & Regulatory Approvals
- CE 0123 — certified by TÜV Rheinland, one of Europe's most respected notified bodies
- BfArM listed — registered with the German Federal Institute for Drugs and Medical Devices
- PEI evaluated — performance evaluated by the Paul Ehrlich Institute
- PZN 8105940 — registered in the German pharmacy product database
- EU-Eudamed — clinical performance data publicly accessible via the European medical device database
Manufacturer: Beijing Hotgen Biotech Co., Ltd. — one of the world's largest rapid test manufacturers with over 1 billion COVID tests produced.
Volume Pricing — From €0.23 Per Test
At parahealth, you buy individual tests (not pre-packaged multipacks) and benefit from automatic volume discounts. The more you order, the less you pay per test — ideal for pharmacies, medical practices, care facilities, and companies. Check the price tier table above for your quantity. For orders exceeding 10,000 units or recurring supply contracts, contact our B2B team at sales@parahealth.de for a custom quote.
Why Buy From parahealth?
- Direct importer: We source directly from manufacturers, cutting out middlemen for the best prices
- Berlin warehouse: AutoStore-powered logistics for fast, accurate order fulfilment
- Free shipping from €100: On all orders within Germany
- Trusted by 350,000+ customers since 2021 — rated 4.8★ from 300+ reviews
- B2B & B2C: Switch between net and gross pricing at any time
Product data
| Category: | COVID-19 Antigen Test |
| Manufacturer: | Hotgen |
| SKU: | RT009 |
| EAN: | 6970297534073 |
| Best before: | 30.09.2026 |
| Test method: | Schnelltest (RDT),Selbsttest (Eigenanwendung) |
| Sample type: | Abstrich |
| IFU languages: | ENDEFRITESPT |
| PZN: | 8105940 |
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
Questions about
this product.
Answers from our medical editorial team. More questions? Write to us.
Mon–Fri, 8:00 to 20:30
How does the Hotgen Corona Rapid Test work?
How accurate is the Hotgen COVID-19 test?
What should I do if my test result is positive?
What does it mean if the test line is very faint?
Can children use this test?
How should I store the test?
What is included in each test?
Why does parahealth sell individual tests instead of multipacks?
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.
