Audasia
Your reliable importer of medical technology

PCR tests are the “gold standard” among corona tests because the test result is the most accurate. The sample collection is done 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 is carried out directly on site and is available within 15 minutes.

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

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

Through our order form here you can order large quantities (from 25,000 pieces). We will then make you an offer
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 the retail trade.

Experts even compare the importance of rapid tests for pandemic containment 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 that are reimbursed when using the rapid antigen tests of the Federal National Testing Strategy in accordance with the Coronavirus Test Regulation of November 30, 2020: List of Manufacturers. The list will be established using minimum criteria and based on manufacturer information. These minimum criteria will be developed by the PEI in consultation with the RKI and adjusted as they progress.

Not so far – 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 February 2, 2021, the Third Ordinance Amending the Medical Devices Tax Ordinance (MPAV) came into force. It now also exempts in vitro diagnostics for self-testing from the physician’s proviso.

At the end of February, the BfArM granted the first special approvals, among others to the Technomed rapid test from the manufacturer Xiamen Boson Biotech Co., Ltd, which we distribute, in accordance with Section 11 (1) of the German Medical Devices Act (MPG) of antigen tests for self-testing by lay persons 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 occupational health and safety measures must be taken into account.

In particular, the correct performance of the nasal or pharyngeal swab, in which infected tissue is collected from the mouth or nasal cavity with a swab, is important. If the swab is performed incorrectly, the result of the rapid test may be falsified.

The accuracy of a test is evaluated using sensitivity (proportion of correct positive test results) and specificity (proportion of correct false results).

The effectiveness of the product is tested in clinical studies 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 samples from the PCR control 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 lay persons (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 BfArM special approval is as follows: 5640-S-007/21.

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

The Green Spring (Colloidal Gold) Antigen Rapid Test continues to reliably identify all current viral 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%.

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

Antigen rapid tests, provided they have received CE approval, are marketable without further requirements or performance criteria. That is why the German Federal Institute for Drugs and Medical Devices (BfArM) has compiled a list of certified products. Only products whose performance data comply with the recommendations of the Paul Ehrlich Institute (PEI) are included in it. The PEI is currently trying to evaluate the products on the market.

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