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.
Sales inquiry / B2B
Interested in bulk orders or reseller pricing? Contact us – we will get back to you as soon as possible.
Or email us directly at sales@parahealth.de
Data sheets & Downloads
Frequently asked questions about this product
How does the Hotgen Corona Rapid Test work?
The Hotgen Corona Antigen Rapid Test uses colloidal gold immunochromatography technology. Simply insert a nasal swab 1.5cm into the nostril, rotate gently for 10 seconds, insert into the extraction buffer, and apply 3 drops to the test cassette. Results appear within 15 minutes. Two lines (C and T) indicate a positive result, while only the control line (C) indicates negative.
How accurate is the Hotgen COVID-19 test?
The Hotgen test demonstrates excellent clinical performance with 97.51% sensitivity (520 positive samples detected out of 533) and 100% specificity (325/325 negative samples correctly identified). Overall agreement with RT-PCR reference standard is 98.48%. The test has been validated against 40+ pathogens with no cross-reactivity, ensuring reliable results even during co-circulating respiratory illness season.
What should I do if my test result is positive?
If your test shows a positive result, isolate immediately from others. Contact your GP or healthcare provider for further guidance. Consider getting a PCR confirmation test if required by your healthcare system. Follow your local health authority's guidelines regarding quarantine period, testing of close contacts, and when it is safe to return to normal activities.
What does it mean if the test line is very faint?
Any visible line at the T (test) position, regardless of intensity or faintness, indicates a positive result. A faint line may suggest a lower viral load, but it is still a positive result. The control line (C) must always appear for a valid test. If the control line is absent, the test is invalid and should be repeated.
Can children use this test?
Yes, children under 18 can safely use the Hotgen Corona Rapid Test under adult supervision. The gentle 1.5cm nasal swab depth makes it suitable and comfortable for all ages, from small children to adults. Adult guidance is recommended to ensure proper swab insertion and sample collection.
How should I store the test?
Store the Hotgen test at temperatures between 2-30°C in a dry place. The test has a 36-month shelf life when sealed in its original pouch. Once the pouch is opened, use the test within 30 minutes. Do not freeze the test or expose it to extreme temperatures, as this may affect accuracy.
What is included in each test?
Each Hotgen Corona Antigen Rapid Test kit contains: 1x test cassette, 1x sterile nasal swab, 1x pre-filled extraction buffer vial, 1x biohazard disposal bag, and 1x instruction for use (IFU) available in 6 languages: German (DE), English (EN), French (FR), Italian (IT), Spanish (ES), and Portuguese (PT).
Why does parahealth sell individual tests instead of multipacks?
We believe in flexibility - you choose exactly the quantity you need without forced pack sizes. Volume pricing applies automatically: from 20 units at €0.52 each, down to €0.23 per test for orders of 9,600 or more. This way, whether you need 1 test or 10,000, you pay a fair price for your exact requirements.
Frequently Asked Questions
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.