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March 2021

Hotgen antigen self-tests

Due to the current situation, more and more individuals are requesting rapid antigen tests that are easy to use and can be performed in the comfort of their own homes. Today we would like to introduce the Coronavirus 2019-nCoV Antigen Test from Hotgen, which is approved as a layman's test for self-testing by private individuals and which you can purchase from our shop. The uncomplicated and painless sample collection from the anterior nasal region makes the handling very easy and the result can already be read after 15 minutes.  

General information on rapid antigen tests

With the aid of an antigen test, viral components of the SARS-CoV-2 virus
can be detected in a sample taken. This sample material is obtained
e.g. via a nasal or throat swab. The sample is first brought into contact with a test liquid so that the virus components can be detached from the swab and transferred to the liquid. This test liquid is then applied to the respective antigen test and then slowly migrates over the entire test strip. This takes an average of 15 minutes. If viral components are present in the sample, they react with coloured molecules at the detection line and a colour band is formed. This results in a qualitative detection of SARS-CoV-2 virus components (antigens). A second color reaction at the control line ensures that the test is functional.

General information on rapid antigen tests

#1 Easy and painless application

Taking the Anterio Nasal Test sample is uncomplicated and painless.
It is a simple swab from the front of the nose. The swab only has to be inserted approx. 1.5 cm into the nose and rotated.

#2 Fast and reliable

The test result can be read off after just 15 minutes, similar to a pregnancy test, a colour bar can be read off. Furthermore the Hotgen test has a high specificity (99,13 (99.13 %) and sensitivity (95.37 %). The specificity tells
whether uninfected persons are also recognized as healthy and sensitivity determines whether diseased persons are also really recognized as such.

#3 Tested and officially listed

The Hotgen Antigen Test has a special approval for self-administration by laypersons (according to § 11 paragraph 1 of the Medical Devices Act, file number: 5640-S-057/21). The test has been evaluated by the Paul Ehrlich Institute and is also listed by the Federal Institute for Drugs and Medical Devices.

#4 Everything in one package

The 1-pack contains everything you need for the test:
A collection swab, sample extraction buffer and a disposal bag.

Small FAQ about the antigen rapid test

What is the rapid antigen test for?

- Rapid antigen tests are currently used in nursing homes, hospitals or schools to test staff or residents on a regular basis. Since February, antigen tests approved for laypersons may also be given to private individuals in order to be able to provide additional safety in specific situations in everyday life.

When is a rapid antigen test most reliable?

- The result of the antigen test depends on the viral load in the sample taken. Especially when the viral load is very high, i.e. a person is very infectious and there is a high probability that he/she will infect other people, this is also indicated by a positive test result in the antigen test. Only in the early as well as the final phase of the infection, when not very many viruses are detectable, it is possible that they will not be detected by a rapid antigen test. However, in this phase the infected person is also not very highly contagious.

How often should rapid antigen tests be performed?

- Since the result of the rapid antigen test only provides a snapshot of the current infectivity, the test should be repeated regularly. The amount and frequency of contacts also depends on the individual. Depending on the situation, it may make sense to test twice a week or even daily.

What is the difference between a rapid antigen test for professionals and an antigen self-test for lay people?

- The sample collection for rapid antigen tests for professional users is usually done via a nasal or oral pharyngeal swab, which is quite uncomfortable and can only be done by a second person. Also, the instructions and product description are designed for medical professionals, which makes it difficult to understand for people who have little or no knowledge in this area. The amendment to the Medical Devices Dispensing Ordinance of 03.02.2021 now also allows the dispensing of rapid antigen tests for private individuals for their own use, which have a marketing authorisation for Germany.

Is there a reporting obligation for rapid antigen tests?
- Positive results of rapid antigen tests are reportable. You should contact the respective health authority or a doctor.

Can the rapid antigen tests also detect the new mutations?
- Yes, even with the two new virus variants B.1.1.7 and B.1.351, the
rapid antigen tests can still provide reliable results, as it is not the spike protein but the nucleocapsid antigen that is detected.

How do I dispose of the used antigen test components?
- You can dispose of the test components in the residual waste. Since this is potentially infectious material, the test components should be securely packaged in an extra trash bag and placed with the rest of the trash in a tightly sealed container.

.If you have any further questions, please visit our FAQ page: https://wingguard.de/pages/faq

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