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MEXACARE with top ratings

In addition to the independent evaluation by the Paul Ehrlich Institute, Stiftung Warentest has now also given the MEXACARE antigen rapid test top marks.

MEXACARE performs very well with a high level of measurement accuracy across all virus concentrations and, according to Stiftung Warentest, the omicron mutation is also easily detected.

Further clinical studies are currently underway to demonstrate the reliable detection of the virus variant BA.5.

The first results already show a clear recognition of the new mutation.

The final study on this will be published separately.



The independent PEI has awarded the MEXACARE Corona Antigen Rapid Test best values ​​in its own test procedure.

The MEXACARE Corona Antigen rapid test is one of the few tests that, according to the PEI internal test procedure, reliably detects omicrons and has a sensitivity of 100% (Ct.<25) and 80% (Ct.25-30).

This means that the antigen rapid test from the German quality manufacturer MEXACARE is one of the leaders in the overall assessment of the PEI.

Test Procedure PEI: Pools were aliquoted, frozen, shipped, and thawed for assay evaluation. For each test, 50 μl of a pool (Panel 1 V1, V2) or 25 μl (Panel 2) with the components provided by the test, e.g. B. swabs and buffers analyzed.


CE-Certification for 3 more years

MEXACARE proved once again that the highly sensitive production processes, the entrepreneurial management and the quality approval requirements of the German diagnostics company, which are becoming increasingly strict according to the IVDR, were passed by the independent notified body without any major deviations.

The major main audit is valid for 3 years and the CE certificate is therefore secured for the German and European market.

Despite an extreme growth phase in 2021, all regulations were met to ensure consistent quality as a German manufacturer of rapid diagnostics.

The regulatory hurdles for the IVDD directive will be tightened in 2022, so MEXACARE GmbH has already proven that it is prepared for the further stricter rules and can look to the coming financial years with confidence.

„MEXACARE GmbH is subject to regular, strict controls of its entire quality management system, which is certified according to DIN-ISO 13485:2016. As part of the annual review by the certified MDC, we had already successfully completed the annual surveillance audit in September 2021 without any major deviations from the requirements required by the standards. MEXACARE was thus very well prepared for the changes to the new IVD directive and the 3-year main audit that had just been passed with full re-certification as a manufacturer of in-vitro diagnostics,“ says Lutz Rothe, Managing Director of MEXACARE GmbH.

In terms of personnel, MEXACARE GmbH has invested in 3 more highly qualified employees and has grown in the regulatory area and is professionally positioned to cope with the increased requirements of the regulatory approval process.

All the quality management documents requested were transparently presented to the auditors of the approval supervision and all processes, as well as studies, approval data and the detailed documentation were presented.

“Every single internal and external process is put through its paces and even a minor deviation can have serious consequences for the continued existence and development of the company. As a German manufacturer, we are particularly proud that the independent inspection authority has approved us as an ISO 13485-certified manufacturer of diagnostics for the next 3 years without a major deviation, so that we were once again able to prove our valued quality and reliability to our customers and business partners,“ says Knut Butzinger , CEO of MEXACARE GmbH.

This DIN ISO 13485:20216 main audit, which lasts several days, corresponds in principle to the granting of a „new“ manufacturer license and includes, among other things, the detailed and most precise review of the product developments, the manufacturing process, the review of the clinical studies and the individual approvals through to the detailed review of the concluded contracts with service providers and partners.



An independent study is to investigate whether the MEXACARE CORONA Home Test Antigen and the MEXACARE COVID-19 Antigen Rapid Test can detect the wild-type, delta and omicron variants of SARS-CoV-2.

The effectiveness of the variant detection is determined in comparison to the sensitivity of the test kit to the wild-type virus. It is also stated whether the sensitivity to the variants is judged to be satisfactory. The test described in this study is a simple, rapid, and laboratory-based qualitative test designed to assess whether the rapid antigen tests detect the delta and omicron variants (+/-) compared to wild-type virus ( original variant, „Wuhan“). A series of viruses diluted in culture medium is used for this purpose.

Testing of the MEXACARE CORONA Home-Test Antigen and the MEXACARE COVID-19 Antigen Rapid Test shows that both tests perform very well at the tested dilutions and both the delta and omicron variants are of comparable magnitudes to the wild type (Wuhan ) can prove.



Another well-known automotive group is convinced of the quality and supply chain management of MEXACARE GmbH, as well as of the fast logistics and on-time delivery – within 48 hours.

The German quality and the particularly high sensitivity convinced the group to choose MEXACARE.

Due to the production in Germany, MEXACARE always has a full central warehouse in order to guarantee a smooth supply chain.



SUPERVALU trusts in the quality of MEXACARE GMBH.

MEXACARE is very pleased to have won the trust of the UK-based premium retailer – SuperValu.

Thus, another large international company joins the portfolio of the group of companies.

With the international expansion of MEXACARE GmbH, the highly sensitive MEXACARE Covid-19 antigen home tests will be available for the first time in Ireland, UK.

When selecting the Covid-19 rapid tests to be sold, SUPERVALU consciously relies on products with the highest quality standards in order to provide the population with sensitive, rapid diagnostic tests.

“The purchase price should only play a secondary role for any responsible company in a pandemic emergency. The safety and sensitivity, which is guaranteed with the MEXACARE rapid tests, should always come first. With SUPERVALU we have gained an important strategic sales partner who values ​​quality and manufacturing in Germany, ”says Knut Butzinger, CEO of MEXACARE.

After a process lasting several weeks, the framework contract was sealed and the first orders were delivered on time to Dublin within a few days after the contract was signed – with a logistics fleet.

MEXACARE’s professional supply chain management controls and monitors the weekly supply chains and guarantees timely delivery, even across national borders.

MEXACARE GmbH is the only German and European manufacturer that has received full CE certification for a COVID-19 antigen home test and a COVID-19 antibody home test from the regulatory authorities.



The drugstore chain Rossmann awarded the German quality manufacturer MEXACARE the renewed order for the production of digital pregnancy tests of the well-known, own brand „Facelle“.

Just like in the past, MEXACARE has now developed a further test for the drugstore chain’s rapid test portfolio, based on Rossmann’s strict guidelines.

The initial stock was delivered in several truck loads.

As a certified in-vitro diagnostics company that has been audited by the approval authority (notified body) without deviations, MEXACARE is characterized by, among other things, local expertise, German quality, direct access to raw materials such as plasma – which are extremely important for the development and validation of rapid tests – as well as through fast delivery times, our own logistics fleet and absolute transparency in the development, manufacture and distribution of high-quality and proven rapid diagnostics.

MEXACARE is demonstrably in a sustainable position to meet the high quality standards as a leading German manufacturer of in-vitro diagnostics.

In addition to pregnancy tests, MEXACARE has already served other orders from the Rossmann drugstore chain and is now present with another new product in over 2500 branches throughout Germany.

MEXACARE GmbH is already planning further large-scale orders from the food retail sector in order to ensure a standardized, excellent and consistent quality of the quick test to be purchased across the whole of the retail sector.

Mexacare also manufactures well-known products for distribution in pharmacies.

As an excellent quality manufacturer and one of the few companies in the world that has CE certification for the COVID-19 antigen and antibody home test, well-known companies such as Stada, Puren, Actavis, MedVec and Rossmann have been placing their trust in MEXACARE GmbH as a contract manufacturer for years.

“We are very happy about the good and sustainable business relationship as a supplier for Rossmann and so we can prove once again that all the rapid tests we produce meet the high quality standards of well-known, internationally established companies. In addition to the COVID-19 relevant large orders to the government of Austria and Baden-Württemberg, hospital and nursing home chains as well as non-profit organizations, we have now successfully started the parallel production of further rapid tests from our portfolio. This will make a significant contribution to the further growth and expansion of our company ”, says Knut Butzinger, CEO of MEXACARE GmbH.



In this year’s multi-day audit, MEXACARE once again demonstrated that quality, professionalism and production in Germany pay off.

The highly sensitive development and production processes, the strict qualitative approval regulations, as well as the corporate responsibility of the German diagnostics company were carefully checked by the independent approval body and the audit was successfully passed without any deviations.

Despite an extreme growth phase in 2021, all approval requirements were met in order to guarantee the consistent, high quality as a German manufacturer of rapid diagnostics.

The regulatory hurdles for IVDD Directive (IVDR) will be tightened in 2022, which is why MEXACARE GmbH has already proven in 2021 that it is prepared for the further stricter rules.

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After MEXACARE was the first German company to receive CE certification for the antibody home test in spring 2021, MEXACARE is now the first German ISO-certified manufacturer of in-vitro diagnostics to have another full CE certification for the MEXACARE antigen home test from the notified body CE0483 received.

The full CE certification, with up to 600 pages of documentation, thus replaces the temporary special approval of the BfArM, under which the currently available rapid tests were brought into circulation temporarily (using a comparatively simple and intransparent express procedure) and outside of the regular approval procedure.

With a sensitivity of 99.9% – even with a high Ct value of up to 34 – the home antigen test from the German in-vitro diagnostics manufacturer MEXACARE is extremely sensitive, and thus also the earliest stages of a potential detect infection.



Against the background of the current pandemic situation in Germany, the Association of the Diagnostics Industry, VDGH, calls for a realignment of the national test strategy.

Above all, the antibody tests that have long been used in other health systems (e.g. France, Italy, GB, Austria) should play an important role.

With the increasing vaccination coverage of the population, antibody diagnostics are becoming much more important than before.

Antibody tests can help in three important areas:

In demonstrating the effectiveness of the vaccines available!

Here, antibody tests can be used to determine evidence-based knowledge about the effectiveness of the vaccines. In addition, an individual success control, as well as the acquisition of new knowledge in patients with previous illnesses (e.g. immunosuppressed patients) is guaranteed.

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The need for rapid tests remains high. In order to be able to meet the great demand, the German diagnostics manufacturer MEXACARE is opening its own test centers.

The first own test center was successfully started in Bad Münstereifel, as the exclusive partner of the City Outlet, in order to reliably test the local retail trade and the population with verifiably 99.9% sensitive tests (even with a Ct value of 34).

With up to 400 tests per day (including symptom query, registration, data collection and actual test execution), the capacities of the MEXACARE rapid test center are well used.

MEXACARE also offers other rapid test centers a 30-day supply of the safe MEXACARE COVID-19 home test antigen without the need for pre-financing.

MEXACARE thus makes a sustainable contribution to fighting pandemics, because responsible testing only makes sense with safe tests in order to get the pandemic under control.



There are problems with the delivery of corona rapid tests in Baden-Württemberg. The state government justifies this with nationwide bottlenecks.

With this background, the Heidelberg diagnostics company distinguishes itself as a reliable strategic partner of the state government and currently supplies almost 1 million antigen home tests to the state of Baden-Württemberg.

In direct consultation with the ministry, delivery should take place within 5 working days to up to 350 locations in the state.

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MEXACARE GmbH is the first medium-sized ISO-certified manufacturer of in-vitro diagnostics to receive approvals for Corona (SARS-CoV-2) home tests. After MEXACARE was the first company to receive full CE certification for the MEXACARE IgG / IgM antibody home test from the notified body – CE0483 – the Federal Ministry for Drugs and Medical Devices (BfArM) has now also granted special approval for the MEXACARE CORONA-19 antigen home test.



MEXACARE receives the official delivery contract for SARS-Cov-2 (Covid-19) antigen tests for the Republic of Austria.

Another government trusts the quality of the German diagnostics company MEXACARE.

The Republic of Austria convinced the 99.9% sensitivity in the particularly important Ct range between 20-34, validated studies, the fast delivery, the customer service and the years of experience of MEXACARE – in the production, validation and approval of rapid diagnostic preparations.


März, KW 15

MEXACARE is among others. Present in Focus, Süddeutsche Zeitung, Aachener Zeitung, Wallstreet Online and other media.

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Self-tests for all – Mexacare from Heidelberg is in the starting blocks. Report by Wolfgang Brauer.




Knut Butzinger, founder of Mexacare, joined Pat on the show to talk about the ten-minute anti-gene tests being delivered to the German and Austrian governments.

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MEXACARE GmbH is the first and only German ISO-certified manufacturer of in-vitro diagnostics to receive full approval for the Corona (SARS-CoV-2) antibody home test. MEXACARE is the first German diagnostics company to obtain full CE certification for the MEXACARE IgG/IgM antibody home test from the Notified Body (CE0483)! After MEXACARE had already submitted the necessary technical documentation and lay studies for a full approval procedure for its antibody home test in April 2020, the first approval for the COVID-19 antibody home test has now come.