Hotgen Coronavirus Antigen Rapid Self-Test, Nasal, 1 Test: Result in 15 Minutes

Self-test for home use, individually wrapped. You buy single tests rather than prepacked multipacks and order exactly the quantity you need.

Hotgen Coronavirus (2019-nCoV) Antigen Rapid Test for Self-Testing

A simple nasal swab, a result in 15 minutes, no laboratory required.

The Hotgen Coronavirus (2019-nCoV) antigen rapid self-test is one of the best known and most widely used COVID-19 self-tests in Germany and across Europe. It is CE marked (CE 0123, TÜV SÜD Product Service GmbH), listed with the German Federal Institute for Drugs and Medical Devices (BfArM), assessed by the Paul Ehrlich Institute and registered in the German pharmacy product database under PZN 8105940.

The test detects SARS-CoV-2 antigens in anterior nasal swab specimens. The swab is inserted only about 1.5 cm into the nostril, which is far more comfortable than a throat or nasopharyngeal swab. After 15 minutes you read the result directly on the test cassette.

The test is validated for use within the first seven days of symptom onset and can also detect infections in people without symptoms. Sensitivity may be lower at very low viral loads.

When to use this test

• Households and families: quick testing when symptoms appear, such as cough, sore throat, fever or loss of taste and smell
• Before visiting people at higher risk: ahead of visits to elderly relatives, care homes or hospitals
• Workplaces and offices: regular screening, particularly for customer-facing staff
• Events and celebrations: before concerts, conferences or family gatherings
• Travel: some destinations still require a negative test on entry
• Schools and nurseries: the gentle 1.5 cm nasal swab is also suitable for supervised testing of children

Key benefits

• Fast result: readable after 15 minutes, no instrument and no laboratory needed
• High accuracy: 97.51 % diagnostic sensitivity and 100 % diagnostic specificity in the manufacturer's clinical study
• Comfortable sampling: only approx. 1.5 cm into the anterior nasal area
• Designed for lay users: illustrated step-by-step instructions plus a video tutorial via QR code
• Suitable for children: usability studied in children aged 2 to 13 years with 100 % diagnostic sensitivity (13/13) and 100 % diagnostic specificity (21/21)
• Variant detection: samples containing the Omicron, Delta, Gamma, Beta and Alpha variants were detected in the study
• Sensitive detection: limit of detection of 200 IU/ml, referenced to the 1st WHO International Standard for SARS-CoV-2 antigen
• No cross-reactivity: validated against more than 40 respiratory viruses, bacteria and fungi
• Individually sealed: each test hygienically wrapped in aluminium foil, ideal for pharmacies, employers and facilities that hand out single units
• Long shelf life: 36 months from manufacture
• No refrigeration required: store at 2 to 30 °C
• Safe disposal: a biohazard bag is included with every test
• Multilingual instructions: German, English, French, Italian, Spanish and Portuguese

How the test works

The Hotgen test uses colloidal gold immunochromatography with a double-antibody sandwich method targeting the SARS-CoV-2 nucleocapsid protein (N protein). When antigen in the sample binds to the colloidal gold labelled antibodies, a complex forms and migrates along the test strip. A visible coloured line at the T position indicates a positive result, while the C line confirms that the test ran correctly.

How to perform the test

1. Wash and dry your hands thoroughly. All components should be at room temperature.
2. Peel open the sampler packaging at the handle end and take out the swab. Do not touch the fabric tip.
3. Insert the swab approx. 1.5 cm into one nostril until slight resistance is felt. Using moderate pressure, rub it along the nasal wall 4 to 6 times for at least 15 seconds.
4. Repeat in the other nostril using the same swab.
5. Open the coloured cap of the tube and insert the swab into the extraction buffer.
6. Soak the swab for at least 15 seconds, rotating it at least 3 times and squeezing the swab head 3 times.
7. Squeeze the sides of the tube as you remove the swab, then close the tube with the coloured lid.
8. Open the foil pouch, take out the test cassette and place it on a flat surface.
9. Open the transparent cap of the tube and add 4 drops to the sample well marked "S".
10. Read the result after 15 minutes. A result read after 30 minutes is invalid.
11. Dispose of all used components in the enclosed biohazard bag and disinfect your hands.

Always follow the instructions for use supplied with the product.

Interpretation of results

A faint test line is also a positive result.

Clinical performance (manufacturer data)

Cross-reactivity: The test was evaluated against more than 40 respiratory viruses, bacteria and fungi with no cross-reactivity. These include human coronaviruses (HKU1, 229E, OC43, NL63), MERS-CoV, adenoviruses, human metapneumovirus, Influenza A (H1N1, H3N2, H5N1, H7N9), Influenza B (Yamagata, Victoria), parainfluenza viruses, enteroviruses, rhinoviruses, RSV, Chlamydia pneumoniae, Legionella pneumophila, Streptococcus pneumoniae, Mycobacterium tuberculosis, Bordetella pertussis, Mycoplasma pneumoniae, Haemophilus influenzae, Candida albicans and Staphylococcus aureus.

Interference: No interference from more than 25 common medicines and endogenous substances, including phenylephrine, oxymetazoline, mometasone, fluticasone, zanamivir, oseltamivir, zinc lozenges, saline nasal spray, throat lozenges, levofloxacin, azithromycin, ceftriaxone, meropenem, tobramycin, mucin and biotin. Also without effect: human anti-mouse antibodies (HAMA) up to 800 ng/ml and whole blood up to 10 % (v/v).

Certifications and registrations

• CE 0123, certified by TÜV SÜD Product Service GmbH, one of Europe's most respected notified bodies
• Listed with BfArM, the German Federal Institute for Drugs and Medical Devices
• Assessed by the Paul Ehrlich Institute
• PZN 8105940, registered in the German pharmacy product database
• EUDAMED, clinical performance data accessible via the European medical device database

The manufacturer is Beijing Hotgen Biotech Co., Ltd., one of the world's largest rapid test manufacturers with more than one billion COVID tests produced.

Technical specifications

Contents per test

• 1 × SARS-CoV-2 antigen test cassette, individually sealed in aluminium foil
• 1 × sterile nasal swab, individually sealed
• 1 × prefilled sample extraction tube with buffer solution
• 1 × biohazard specimen bag
• 1 × multilingual instructions for use (DE, EN, FR, IT, ES, PT)

Also required: a clock or timer.

Single tests instead of multipacks

You buy single tests rather than prepacked multipacks and order exactly the quantity you need. This suits pharmacies, medical practices, care facilities and companies that hand out tests individually. For larger volumes from 10,000 units or recurring supply agreements, contact our B2B team at sales@parahealth.de.

Why buy from parahealth

• Direct importer: sourced directly from the manufacturer, with no intermediaries
• Warehouse in Berlin: AutoStore-based logistics for fast and accurate order fulfilment
• More than 350,000 satisfied customers since 2021, rated 4.8 out of 5 stars from over 300 reviews
• B2B and B2C: switch between net and gross display at any time

Important information

• For in vitro diagnostic use. Please read the instructions for use completely before performing the test.
• Children and young people under the age of 18 should perform the test under adult supervision.
• The test is qualitative and cannot quantify the concentration of SARS-CoV-2 antigen.
• A positive result indicates a possible infection and should be confirmed by PCR in accordance with local rules. Please contact your doctor.
• A negative result does not rule out infection, for example if the viral load is below the limit of detection. Contact your doctor if symptoms persist or worsen.
• Do not make any medical decisions without consulting your doctor.
• Do not drink the extraction buffer and avoid contact with eyes and skin. Keep out of reach of children.
• Each test cassette is for single use only and must not be used by more than one person.
• Do not interchange components from different kits. Do not use if the pouch is damaged.
• For use with human specimens only.
• Collect used components in the enclosed biohazard bag and dispose of them in accordance with local regulations.