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DiaSys Diagnostic Systems GmbH

Alte Straße 9, 65558 Holzheim
Germany
Telephone +49 6432 9146-0
Fax +49 6432 9146-32
marketing@diasys.de

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Contact

Dr. Guenther Gorka

CEO

Dr. Jan Gorka

CEO

Peter Zöller

CEO; Head of Purchasing

Christophe Bayet

General Manager Global Business / Head of Sales; Responsible for: West-Europe, Maghreb, French-Africa

Péter Aradi

Area Business Director; Responsible for: from East-Europe to East Africa; Scandinavia; Kazakhstan and Uzbekistan

Chee Kian Teo

Area Business Director; Responsible for: South East Asia, Korea, Taiwan, Nepal, Australia, and Kyrgyzstan

Roland Heyer

Area Business Director; Responsible for: South and Middle America, Portugal, Spain, South African countries

Dr. Michael Sprinzl

Area Business Director; Responsible for: Czech Republic and Slovakia

Irene Delseith-Hermsdorf

Head of Marketing / Product Manager Reagents: Lipids & Atherosclerosis

Isabella Wieland

Product Manager Reagents: Diabetes, Electrolytes (except lactate), Liver, Iron Metabolism, Pancreatic Function

Andreas Bäcker

Product Manager Reagents: Cardiac Markers, Inflammatory & Rheumatoid Arthritis, Immune System, Nutrition, Renal Function

David Ehlers

Product Manager Systems: respons® system family, InnovaStar®, SensoStar

Dominik Bender

Product Manager Systems: BioMajesty® JCA-6010/C, StarDust MC15, Water Purification Systems

Carmen Pott

Supply Chain Management; Assistant Purchasing

Sibylle Fein-Kremer

Purchasing Instruments

Our range of products

Our products

Product category: Other diagnostics

COVID-19 Antibody Testing - DiaSys SARS-CoV-2 UTAB FS - coming soon

In response to COVID-19, DiaSys currently develops a serological assay to detect SARS-CoV-2 total antibodies. This test allows identification of individuals who have developed an immune response against the virus, even if they were asymptomatic or never have been diagnosed with the disease.

The SARS-CoV-2 UTAB FS assay is a particle enhanced immunoturbidimetric assays (PETIA) which enable a qualitative resp. semi-quantitative detection of total antibodies to SARS-CoV-2 in human serum and plasma. Since neutralizing antibodies directed against the spike protein can induce protective immunity against viral infection, the new DiaSys assay SARS-CoV-2 UTAB FS targets antibodies directed against the receptor binding domain (RBD) of the viral spike protein. This region is responsible for binding to the host cell receptor, allowing the virus to enter the host cell. The serological test offers high specificity and sensitivity and shows no cross-reactivity to the four human coronaviruses, which share partial sequence homology with SARS-CoV-2. Therefore, it reduces the risk of false positives due to the detection of similar antibodies that may be present. The innovative DiaSys reagent and the dedicated calibrators and controls will be available as liquid-stable products. The suffix UTAB - Universal Total Antibody - in the product name refers to the fact that this test can be applied on almost all clinical chemistry analyzers.

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Product category: Other diagnostics

COVID-19 Antigen Rapid Test - immediately available

DiaSys is pleased to provide a rapid test for qualitative detection of specific antigens in COVID-19. The gold nanoparticle-based immunochromatographic test, SGTi-flex COVID-19 Ag, enables a qualitative determination from nasopharyngeal and oropharyngeal swab. It offers high sensitivity and specificity, and shows no cross-reactivity by other viruses or pathogens. The test delivers results wirhin only 20 - 30 minutes. It does not require any additional materials or device, thereby, increasing the testing capacity, especially in countries that do not have extensive laboratory facilities for molecular testing (polymerase chain reaction or PCR).

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Product category: Other diagnostics

COVID-19 IgM/IgG Antibody Rapid Test - immediately available

With immediate effect, DiaSys offers a rapid test for the detection of IgM and IgG antibodies in COVID-19. The gold nanoparticle-based immunochromatographic test SGTi-flex COVID-19 IgM/IgG allows qualitative determination in whole blood (finger prick blood), serum und plasma. It exhibits high specificity and sensitivity, shows no cross-reactivity by other viruses or pathogens and delivers reliable results within 10 to 15 minutes. The new product will positively contribute to pandemic management because this test is fast, reduces workload on centralized testing laboratories and is the test of choice in resource-limited countries.

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Product category: Other diagnostics

Influenza A&B Rapid Test - immediately available

DiaSys is please to let you know, that we offer a rapid test for influenza A and/or B detection. SGTi-flex Influenza A&B test is a lateral flow immunochromatographic assay based on gold nanoparticles and allows a differential diagnosis of influenza A and/or B. Measurements are performed from samples of nasopharyngeal swab. Supported by high specificity and sensitivity, no cross-reactivity by other viruses or pathogens and ease of use, qualitative and reliable results are available after 3-10 minutes.

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Product category: Other diagnostics

DiaSys Parameters in COVID-19 Monitoring

Laboratory medicine plays an important role in early detection, diagnosis and treatment of COVID-19. The IFCC has published an information guide on biochemical monitoring of COVID-19 patients. DiaSys offers a variety of reagents for parameters that are recommended for monitoring of the disease. For more information on DiaSys parameters in COVID-19 monitoring, please visit the attached pdfs where you can find summaries for each parameter.

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Product category: Other diagnostics

Procalcitonin FS

Serum procalcitonin (PCT) levels are a sensitive marker for severe and systemic bacterial infections. PCT is primarily produced in thyroid C cells as a precursor of calcitonin but expressed in nearly all tissues by stimulation of interleukins and bacterial endotoxins. In healthy individuals, PCT concentrations are usually below 0.05 ng/mL, and a significant increase of PCT up to a thousand-fold appears within a few hours in patients with severe and systemic bacterial infections.

DiaSys Procalcitonin FS is a fluid-stable, particle enhanced immunoturbidimetric assay with outstanding onboard and calibration stability, providing a convenient workflow on clinical chemistry analyzers. Determinations of PCT in serum and plasma within the measuring range from 0.2 ng/mL to 50 ng/mL can be performed with high precision at clinical cut-off levels for sepsis. The performance is complemented by high tolerance to endogenous interferents and various therapeutics used in sepsis management. Procalcitonin FS shows a good correlation to established methods. Results from ring trials and a publication demonstrate the strengths of the assay.

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Product category: Analyser systems / equipment, Other equipment for clinical chemistry

respons®940 – Clinical Chemistry Analyzer

respons®940 is a fully automatic random access analyzer (RAM) with a sample throughput of 400 (640 incl. ISE) tests/hour. Due to durable quartz cuvettes, low reaction volume, maintenance free photometer and intuitively operated software, respons®940 offers the economic use and reliability required in small to medium sized labs. In combination with DiaSys' high quality reagents perfectly matching to respons®940 highest results security and therefore a minimized number of reruns can be assured.

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Product category: Other equipment for clinical chemistry

Water Purification Systems by DiaSys

The accuracy and reliability of measurement results depend to a large extent on the quality of the process water used. 
The DiaSys water purification systems O classic, O mini and O maxi work with coordinated cleaning steps to produce purest water of highest quality. The systems are designed to work perfectly with our analyzers. They produce from 15 L/h up to 55 L/h and have a water buffer tank from 9 L up to 75 L capacity. With these water treatment systems and together with our reagents and analytical instruments, DiaSys offers the complete package for reliable results.
In addition, the respons®920 and respons®940 analyzers offer the option of using an autofilling system to avoid the inconvenience of filling the deionized water tank. The autofilling system is installed directly in the deionized water tank and connected to the water purification system, eliminating the time needed to refill the water tank and eliminating the risk of the analyzer stopping due to lack of water. This makes your laboratory work even more efficient.
DiaSys – Choosing Quality.  Also for laboratory water!

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Product category: Other diagnostics

Total bile acids 21 FS

Increased serum bile acid levels are associated with several diseases such as acute and chronic hepatitis, intrahepatic cholestasis of pregnancy, liver sclerosis, cirrhosis, and cancer. Commercially available assays show limitations regarding the detection of clinically relevant primary and secondary bile acids. DiaSys introduces a liquid-stable, ready-to-use reagent with excellent recovery of diagnostically relevant bile acids (target deviation ≤ 7%). DiaSys Total bile acids 21 FS has a wide measuring range, good precision and long onboard and calibration stability. DiaSys provides a dedicated calibrator for optimum performance and multi-parameter controls for a convenient workflow.

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Product category: Other diagnostics

Lp-PLA2 - Advanced lipoprotein testing

Lp-PLA2 activity has proven to be a biomarker for increased atherosclerotic cardiovascular disease (ASCVD) risk, independently and in addition to traditional risk factors. Lp-PLA2 testing is recommended in 4 major guidelines for patients’ estimated to be at moderate or high CVD risk by traditional risk assessment. In compliance with the NCEP-ATPIII (National Education Adult Treatment Panel III), Lp-PLA2 measurement is recommended in addition to classical risk markers like LDL, Lp(a), and homocysteine.

DiaSys Lp-PLA2 FS measures the activity of the vascular-specific inflammatory enzyme in blood. In 2019, results of a Chinese study, published in the Journal of Clinical Laboratory Analysis, showed that DiaSys Lp-PLA2 FS is superior to other available activity assays. DiaSys Lp-PLA2 FS offers a wide measuring range and superior on-board and calibration stability. Due to the lack of a reference method or reference material for Lp-PLA2, DiaSys has standardized the Lp-PLA2 test system to the reagent specific molar extinction coefficient of 4 nitrophenol, therefore offers a scientifically proven traceability for the reagent.

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Company news

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Nov 18, 2020

Outstanding performance of DiaSys PCT FS - scientifically proven

In July 2020, five months after the product launch, Dupuy (et al.) published the first peer-reviewed publication on Procalcitonin FS in the MDPI (Multidisciplinary Digital Publishing Institute) journal Diagnostics (Vol. 10, Issue 7). The study compared the performance of DiaSys' new procalcitonin assay with BRAHMS PCT Kryptor© and another turbidimetric assay. DiaSys Procalcitonin FS demonstrated its strengths in the study and can truly be accepted as a reliable alternative for clinical use.

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Nov 18, 2020

Water is the key DiaSys new water purification systems

DiaSys is proud to present its new water purification systems: O classic, O mini and O maxi. The accuracy and reliability of test results depend to a large extent on the quality of the process water. This is not only used for cleaning needles and cuvettes but also directly in the measurement for determining blank values or for diluting samples. Particles and impurities in addition to bacteria and ions must be removed from the water. DiaSys water purification systems work with coordinated processing steps to produce purest water of highest quality. With the water purification systems and together with our reagents and analytical instruments, DiaSys offers the complete package for reliable results.

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Nov 17, 2020

New reagent Procalcitonin FS

Precise • Cost-efficient • Time-saving

Our new, liquid-stable and ready-to-use reagent Procalcitonin FS is now available.

DiaSys Procalcitonin FS is a particle enhanced immunoturbidimetric assay for the determination of Procalcitonin (PCT) in serum and plasma on photometric systems. The assay offers a measuring range from 0.2 ng/mL to 50 ng/mL and high precision at clinical cut-off levels for sepsis. No prozone effect was observed up to 1000 ng/mL. Furthermore, Procalcitonin FS has an outstanding onboard und calibration stability. The assay performance is complemented by high tolerance to endogenous interferents and common therapeutics used in sepsis management.

Procalcitonin is a 116 amino acid prohormone of calcitonin. In healthy individuals, serum levels of PCT are very low (< 0.05 ng/mL); upon stimulation by bacterial toxins and inflammatory cytokines, PCT is expressed in nearly all tissues. In patients with systemic bacterial infections, such as sepsis, serum PCT levels rise from
< 0.1 ng/mL up to 1000 ng/mL within a few hours.

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Nov 17, 2020

DiaSys publication at ABC Journal

In cooperation with Fresenius University of Applied Sciences in Idstein and the Technical University of Darmstadt, DiaSys has published an article in the journal Analytical and Bioanalytical Chemistry about the standardization of HbA1c. For many years, DiaSys enjoys a close cooperation with the University of Applied Science Fresenius in Idstein. Fresenius looks back on more than 160 years of scientific tradition from its foundation as a school of chemistry in 1848 – in fact, the founder Carl Remigius Fresenius is seen as the originator of food and diagnostic analytical sciences.

The published article describes the synthesis of two clinically relevant fructosamines Fru-Val and Fru-Val-His via a protected glucosone intermediate, which is a new, fast and efficient protocol for the synthesis and purification of fructosamines in suitable yield and purity.

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Nov 16, 2020

New Reagent for Direct Determination of HDL-cholesterol

DiaSys is pleased to offer HDL-c direct FS, a new homogenous assay for direct determination of HDL-cholesterol (HDL-C). HDL-C monitoring is of great importance for cardiovascular risk assessment since reduced concentrations of HDL-C, especially in combination with elevated triglycerides are associated with high risk of atherosclerotic heart disease.

The new DiaSys method is characterized by a wide measuring range and shows good overall precision and precision in series at the clinical decision limits. The ready-to-use reagent HDL-c direct FS offers long onboard stability and low calibration frequency.

The new test works on all automated clinical chemical analyzers and shows good comparability with commercially available methods for the determination of HDL-cholesterol.

The new test is available in different kit concepts for manual and automated use.

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Nov 16, 2020

DiaSys is Corresponding Member of the IFCC Task Force on COVID-19

Since June 3, 2020, DiaSys is part of the IFCC Task Force on COVID-19.

The major objectives of this Task Force include regular provision of up-to-date information on epidemiology, pathogenesis and laboratory diagnostics of COVID-19. Furthermore, practical recommendations to harmonize the use of diagnostic tests for COVID-19 as well as biosafety measures for sample handling will be developed. In addition, international studies will be organized to improve the knowledge on pathogenesis, diagnostics and therapeutic handling of COVID-19.

In addition to the extensive product portfolio for the companion diagnostics of COVID-19, DiaSys makes another important contribution to the active containment and combat of the coronavirus.

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Nov 13, 2020

New Rapid Test for Influenza A&B Immediately Available

DiaSys introduces a rapid test for determination of influenza A and/or B from samples of nasopharyngeal swab. The SGTi-flex Influenza A&B is a cartridge based immunochromatographic lateral flow assay providing results within a short time combined with ease of use and safe handling. Clearly separated test lines allow a differentiation between influenza A and/or B virus and indicate as well the validity of each measurement by a control line.
For further information on the product, please contact the Product Managers or your responsible Area Business Director.

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Nov 10, 2020

Introducing SARS-CoV-2 UTAB FS - coming soon

DiaSys is pleased to announce an innovative test to detect antibodies against the novel coronavirus SARS-CoV-2. This liquid-stable and state-of-the-art SARS-CoV-2 UTAB FS assay will soon be added to their portfolio along with the dedicated calibrators and controls. It is a particle enhanced immunoturbidimetric, liquid-stable assay allowing a qualitative resp. semi-quantitative detection of total antibodies against SARS-CoV-2 in human serum and plasma. The assay targets antibodies directed against the receptor binding domain (RBD) of the viral spike protein since those antibodies block the interaction between the virus and the host cell receptor, thereby effectively prevent the infection of SARS‐CoV‐2.
As indicated in the suffix of the product name UTAB – Universal Total Antibody - the test can be run on almost all clinical chemistry analyzers. The assay is characterized by high specificity as well as sensitivity and shows no cross-reactivity to other coronaviruses, which share partial sequence homology with SARS-CoV-2.

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Nov 6, 2020

New Rapid Test for IgM/IgG Antibodies in COVID-19 Immediately Available

An urgent need for reliable antibody detection prevails to analyze the spread of COVID-19. It is as well closely linked to vaccine development, safe release of individuals from quarantine, and to develop population lock-down exit strategies.

With immediate effect, DiaSys offers a rapid test for determination of IgM and IgG antibodies in whole blood (finger prick blood). The gold nanoparticle-based immunochromatographic rapid test SGTi-flex COVID-19 IgM/IgG, for qualitative detection of antibodies in COVID-19, exhibits high specificity and sensitivity, and delivers reliable results within 10-15 minutes. For further information on the product, please contact the Product Managers or your responsible Area Business Director.

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Nov 6, 2020

New COVID-19 Antigen Rapid Test Immediately Available

DiaSys is pleased to provide a rapid test for qualitative detection of specific antigens in COVID-19. The new antigen rapid test, SGTi-flex COVID-19 Ag, enables a fast decision making whether quarantine is necessary, to reduce the spread of the virus resp. for screening of individuals with an increased risk of exposure (health care professionals). The gold nanoparticle-based immunochromatographic rapid test is highly sensitive and specific, and easy to perform, without any additional equipment. The new rapid test, which allows determination in nasopharyngeal and oropharyngeal swabs, delivers reliable results within 20 - 30 minutes.
For further information, please contact DiaSys’ Product Managers or your responsible Area Business Director.

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Nov 5, 2020

The New Family Member: respons®940

respons®940 is a random access analyzer with a true throughput of 400 tests/hour (640 tests/hour with ISE) irrespective of whether mono- or 2-component tests are performed.
With an onboard capacity of 36 different methods in mono- or twin containers, 50 bar coded samples plus 30 positions for calibrators, controls or emergency samples, respons®940 offers almost unlimited flexibility in organizing laboratory workflows. Ready-to-use reagents, one-grip loading of reagent containers, integrated bar code reader for samples and reagents, durable hard glass cuvettes, a maintenance free photometric unit as well as a modern software interface turn respons®940 into an all-round system for everyday use.
Due to minimized reagent consumption and the well-known quality of DiaSys reagents with long-term stability and broad measuring ranges which minimizes the need for re-runs, respons®940 represents the economical analyzer for medium sized modern laboratories.

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About us

Company details

Diagnostic Reagents and System Solutions of Outstanding Quality!

DiaSys Diagnostic Systems is a leading specialist in development and manufacturing of diagnostic system solutions. Our goal is to combine high quality with ease of use and to reduce the environmental burden. Focusing on clinical chemistry and immunoturbidimetric tests, DiaSys has introduced more than 100 reagents in user-friendly kits for manual or automated use. DiaSys reagents ensure reliable results in routine and special diagnostics as e.g. diabetes, metabolic syndrome, lipid disorders, iron metabolism, pancreatic, kidney or liver diseases.

The instrumentation portfolio comprises automated clinical chemistry analyzers for small to medium sized laboratories (respons®910, respons®920, respons®940 and BioMajesty®JCA-BM 6010/C), semi-automated analyzers (StarDust MC15) and POCT instruments (InnovaStar® and SensoStar). Additionally, DiaSys offers a broad range of calibrators (TruCal) and quality control material (TruLab).

DiaSys continuously expands its reagent and system portfolio.

At the beginning of 2020, DiaSys launched a new sensitive marker for severe and systemic bacterial infections – Procalcitonin FS. DiaSys Procalcitonin FS is a fluid-stable, particle enhanced immunoturbidimetric assay with good precision at clinical cut-offs for sepsis. The assay has an outstanding onboard and calibration stability. The performance of Procalcitonin FS is comparable to established methods, presenting a reliable alternative for clinical chemistry analyzers.

DiaSys is an ISO certified company since 1996 (ISO 13485). To date, customers and partners in more than 100 countries rely on DiaSys’ quality.

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Company data

Foundation

1991

Area of business
  • Laboratory Equipment
  • Diagnostics