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PCR tests are the "gold standard" among corona tests because the test result is the most accurate. The samples are taken by medical personnel - the evaluation by laboratories.

Rapid antigen tests for SARS-CoV-2 work on a similar principle to pregnancy tests. They can only be performed by trained personnel - for this purpose, a nasal or throat swab is taken, similar to the PCR test. However, in contrast to the PCR test, the evaluation takes place directly on site and is available within 15 minutes.

Laity self-tests are intended for use by private individuals. For this purpose, sample collection and evaluation must be correspondingly simple.

In our online shop you can buy small quantities (up to 25000 pieces).

You can order large quantities (from 25,000 pieces) using our order form here. We will then make you an offer adapted to your needs.

Rapid antigen tests can help detect infected individuals and break chains of infection. Once they are widely available, testing can be more regular, widespread and low-threshold. This means better protection for all those who inevitably come into contact, for example in the care and health sectors, in schools and daycare centers, and in retail.

Experts even compare the importance of rapid tests for containing the pandemic with that of vaccinations. Martin Stürmer speaks of "a big step toward freedom.

The Federal Institute for Drugs and Medical Devices (BfArM) maintains a list of rapid tests which, when using the antigen rapid tests of the national test strategy of the federal government, are to be used in accordance with the Coronavirus Test Ordinance of November 30, 2020: List of manufacturers. The list is created using minimum criteria and based on manufacturer information. These minimum criteria are developed by the PEI in consultation with the RKI and adjusted over time.

Not yet - especially not for the private sector. However, anyone who does a positive layman's self-test should have it confirmed by a PCR test, just as in the case of a positive rapid antigen test, and as a precautionary measure should quarantine themselves at home until the result is available.

On 2. February 2021 the Third ordinance to amend the Medical Devices Tax Ordinance (MPAV) came into force. This now also exempts in-vitro diagnostics for personal use from the doctor's stipulation.

At the end of February, the BfArM received the first special approvals, including for the Technomed rapid test we sell from the manufacturer Xiamen Boson Biotech Co., Ltd according to Section 11 Paragraph 1 of the Medical Devices Act (MPG) of antigen tests for self-application by laypersons (self-tests) for the detection of SARS-CoV-2. Further special approvals will follow.

The majority of rapid antigen tests must be performed by medically trained persons and appropriate health and safety measures must be taken into account.

It is particularly important to correctly carry out the nose or throat swab, in which infected tissue is removed from the mouth or nose with a swab. If the smear test is carried out incorrectly, the result of the rapid test may be incorrect.

The accuracy of a test is evaluated using sensitivity (proportion of true positives) and specificity (proportion of false positives).

The efficacy of the product is tested in clinical trials, in which the results of the rapid test are compared with a PCR test.

For example, a 98% sensitivity in a study means that 98% of all positive PCR control samples were correctly detected by the rapid test.

Currently, the dispensing is done to medical or "trained personnel". There are numerous exceptions, such as schools and daycare centers, community facilities, critical infrastructure, as well as government and administration and media and culture. Details can be found in the Federal Gazette (as of 02.02.21).

The BfArM has granted the first special approvals according to §11 paragraph 1 of the Medical Devices Act (MPG) of antigen tests for self-administration by laypersons (self-tests) for the detection of SARS-CoV-2.

Among the first tests approved for this purpose are the Technomed tests with registration number AT116/20. The file number of the special approval of the BfArM is the following: 5640-S-007/21.

The Xiamen Boson Biontech rapid antigen test has been successfully used millions of times throughout Europe and
detects novel mutations reliably.

The Green Spring (Colloidal Gold) Antigen Rapid Test continues to reliably identify all current virus variants. Like most colloidal gold-based rapid tests, this test uses interaction with antigenic sites in the N protein. Mutations from the United Kingdom (B.1.1.7), South Africa (B.1.351), and Brazil (B.1.1.28 P.1) mainly involve changes in the S protein. Therefore, there is currently no evidence that these mutations affect the performance of N-protein-based rapid antigen tests.

Compared to the PCR test, a rapid antigen test is not as sensitive or specific. High-quality rapid tests are those tests that provide as few false-negative and false-positive results as possible, i.e. those that have a high sensitivity >90% and a high specificity >98% > exhibit.

Our products are clinically tested and have a sensitivity between 96.5% (Technomed) and 98.0% (Green Spring). The specificity is also correspondingly high: 99.0% for Technomed and 100.0% for Green Spring.

Rapid antigen tests that have received CE approval are marketable without further conditions or performance criteria. That is why the Federal Institute for Drugs (BfArM) has drawn up a list of certified products. Only products whose performance data correspond to the recommendations of the Paul-Ehrlich-Institut (PEI) are included. The PEI is currently trying to evaluate the products on the market.

The antigen rapid tests we offer are all BfArM listed and have already been successfully evaluated by the PEI.