CLUNGENE® Covid-19 Antigen Rapid Test, Approval Private Use / Self-administration by Lay Persons, Perfect for families and companies, File Number Special Approval 5640-S-168/21 – BfArM Listing (reimbursable) – PZN: 16943382 (5 tests per box)24. March 2021
COVID-19 Anbio Xiamen Antigen Rapid Test Kit (colloidal gold) – BfArm: AT195/21 – BfArM Listing (reimbursable) – Detects Delta virus variant B.1.617.2 (20 tests per box)4. April 2021
HOTGEN Covid-19 Antigen Rapid Test, Approval Private use / Self-application by laymen, Ideal for families and companies, CE0123, BfArM listing (reimbursable) – PZN: 08012178 – PEI evaluated (5 tests per box)
The Covid-19 test for individuals (layman application)
The easy and painless application makes this test especially suitable for seniors, children and people with handicap!
Covid-19 test ideal for:
- Kindergartens / day care centers
- Schools / universities
- Tour operators
- Airlines / shipping companies
- Hotels / hospitality industry
- Catering establishments
- Public events, trade shows, and conventions
- Companies that cannot afford a home office
- Large businesses/factories/manufacturing facilities
- Nursing facilities
- Opticians / podiatrists / medical supply stores
- Nail studios
- Cosmetic studios
- Public facilities
- Fitness studios
Package content per unit:
- 5 Pack COVID-19 HOTGEN Antigen Rapid Test
- 5 piece coronavirus antigen test cassette
- 5 piece Sampling tube with cap and extraction buffer
- 5 piece Sterile swab
- 5 piece Disposable disposal bag
- 1 piece Instructions for use
- Sensitivity: 95,37%
- Specificity: 99,13%
- PZN: 08012178
- EU-RAT Listing No. 2807
HOTGEN Covid-19 antigen rapid test with lay approval
Rapid tests represent an important part in the follow-up of COVID-19 infection events. However, a regular test typically requires medically trained professionals to perform. An alternative product is now available in the form of the HOTGEN Covid-19 Rapid Antigen Test. The tests are provided with approval for private use. Thus, even laypersons are able to use the test.
Scope of the test kit
Each box of the HOTGEN Covid-19 antigen rapid test kit contains one test. The test kit consists of:
- Test cassette
- Sample tube
- nasal swab
- Waste bag
- Instructions for use
How the rapid test works
The lay-approved tests work on the same principle as other COVID-19 rapid tests. They require a swab from the nose or throat to provide evidence of viral infection. The key difference from a regular pharmacist’s test is that the swab is taken from the anterior nasal or pharyngeal cavity, rather than the posterior region. Therefore, the test procedure does not require a medically trained professional to properly perform specimen collection.
The use of the test for lay people – who potentially benefits from this product
This lay-approved test can be used in diverse places where rapid testing procedures are required. This applies to a wide variety of facilities, companies and government agencies. Important end users include kindergartens, schools and universities. Public institutions, banks, production facilities of companies, gastronomy, hotel and travel industry also benefit from tests for laymen. The same applies to hairdressers, nail and cosmetic studios.
In principle, the use of the test is suitable wherever regular hygiene and distance rules cannot be observed or do not provide sufficient protection. Also, the lack of medically trained professionals suggests tests with approval for private use. Because of its easy and painless application, this test particularly facilitates sample collection from sensitive target groups such as children, seniors, or people with handicaps.
Quality and safety of the COVID-19 antigen rapid test
The test kit is equipped with all the necessary utensils for a rapid test procedure. Independent of laboratory facilities, these tests can be used for home or on-site in the respective professional environment. The recommendation is to use disposable gloves to perform the test and to create the most hygienic test environment possible. Users should disinfect the surface on which they place the test kit or its components.
The sensitivity of this test is 96.62%, and the specificity is 99.76%. This results in an accuracy of 97.31 %. The test result is available after 15 to 20 minutes.
Special approval by BfArM and Paul Ehrlich Institute (PEI)
With the file number 5640-S-057/21, the special approval was granted by the BfArM (Federal Institute for Drugs and Medical Devices) in accordance with Section 11 (1) of the German Medical Devices Act (MPG). This means that rapid tests suitable for laypersons for the detection of SARS-CoV-2 have been approved. In addition, the HOTGEN Covid-19 antigen rapid test complies with the requirements of the Paul Ehrlich Institute (PEI), the Federal Institute for Vaccines and Biomedical Medicinal Products.
Notes on sale by PSA partners
Thanks to the special approval, sales via PSA partners can also be made to private individuals. In addition to purchasing smaller quantities of 10 or more, we also accept wholesale requests. Accordingly, we supply a large customer base, which passes on these tests for laymen to the respective end customers.
You have further questions about our offer? Contact us and we will be happy to help you. Order the BfArM-approved rapid test and other high-quality protective equipment now from PSA-Partner.
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