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Audasia
Your reliable importer of medical technology

Fast and safe care with the
medical products from Audasia

Our Medical Products

Medical products for retailers and end users.
You are a pharmacist, doctor, own a test center or are a dealer? Then request a quote for our products now.

Green Spring® 4 in 1 Antigen-Schnelltest bei audasia kaufen

Green Spring® 4 in 1 Antigen Rapid Test

The Green Spring Antigen Rapid Test is suitable for use by healthcare professionals as well as for self-testing.

Jucheng_SARS-CoV-2_Ag_Schnelltestkit

Jucheng SARS-CoV-2 Ag Rapid Test Kit

The Jucheng SARS-CoV-2 Antigen Rapid Test Kit is for use by healthcare professionals.

GenSure™ COVID-19 Antigen-Schnelltestkit

GenSure™ COVID-19 Antigen Rapid Test Kit

The GenSure™ COVID-19 Antigen Rapid Test Kit is suitable for use by healthcare professionals as well as for self-testing.

Sejoy SARS-CoV-2 Antigen Rapid Test Cassette

The Sejoy Rapid Antigen Test is available for use by healthcare professionals as well as for self-testing.

Sejoy bei audasia kaufen
Alltest-Covid-19-Antigen-Rapid-Testt audasia

Alltest Covid-19 Antigen Rapid Test

The Alltest Covid-19 Antigen Rapid Test is approved for self-testing. It is available as a spit test, as well as a nasal antigen test.

Alltest bei audasia kaufen
PLUSLI-FE-SARS-COV-2-TEST-KITS

pluslife SARS COV-2 Test Kits

The fast, accurate, laboratory-quality results can be used as a clinical reference, optimizing clinical and practice workflows.

pluslife-Logo
PLUSLIFE-MINI-DOCK-TESTGERAeT

pluslife Mini Dock test device

The fast, accurate, laboratory-quality results can be used as a clinical reference, optimizing clinical and practice workflows.

pluslife-Logo
Packung__à_40_Masken__FFP2_Atemschutzmaske_LXD-02_einzelverpackt audasia

FFP2 respirator LXD-02 individually packed pack (40 masks)

Our FFP2 mask fully complies with the European Standard EN149:2001+A1:2009, classification: FFP2 NR, test report of the European notified body 1463.

LXD

About Us

Fast and safe care - with medical products from audasia

The trading company Audasia GmbH is a registered medical company based in Munich, which supplies Corona protection products such as FFP2 masks and rapid antigen tests directly from the manufacturer to you.

We have been supplying medical and pharmaceutical customers since the SARS-CoV2 outbreak and have excellent references and contacts in the PPE field worldwide.

We communicate directly with the manufacturer, thus saving the way through intermediaries and thus costs. Deliveries are made by the shortest possible route from our two regional distribution and fulfillment locations.

Do you have further questions about the company? Please contact us.

Questions & Answers

FAQ – Frequently Asked Questions

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.

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