ORGENTEC

ORGENTEC is proud of our unique and comprehensive autoimmune and specialty diagnostics portfolio. ORGENTEC is offering more than 200 assays for Alegria®, ELISA, Immunofluorescence and Immunoblot technologies. More than 130 different Alegria® Monotest assays are available.

We are setting high standards with deep autoimmune expertise and scientific knowhow to make a difference and enable laboratory to diagnose complex autoimmune disease.

Since its inception in 1988, Mainz-based ORGENTEC Diagnostika has been a world market leader in the development, production, and marketing of test systems for laboratory autoimmune diagnostics. ORGENTEC as an expert manufacturer has developed more than 200 highly specific ELISA test systems, as well as blot and immunofluorescence tests for diagnosing autoimmune diseases (autoimmune disease diagnostics) and infection serology (infectious disease diagnostics). Many of these are protected by patent rights.

Comprehensive Product Portfolio

We offer test systems for diagnostics and treatment-associated monitoring in the following clinical areas:

  • Diagnosis of inflammatory rheumatic diseases – this is clearly the main focus of our research and development efforts
  • Thrombosis diagnostics – we now offer more than 30 different test systems in this area
  • ANCA diagnostics for the serological detection of autoimmune vasculitides
    thyroid diagnostics, gastroenterology, diabetes diagnostics, etc.
  • ELISA test systems for fully automated infectious disease diagnostics – infection serology

Consistency in Quality and Service

ORGENTEC in vitro diagnostic medical devices (IVD) are CE marked. Our quality management system is certified according to ISO 13485 in the latest version.

Alegria® for autoimmune and infectious diseases diagnostics

Alegria® for autoimmune and infectious diseases diagnostics

Alegria® – The Smart Analyser

The random access analyser Alegria®, based on SMC® Technology developed by ORGENTEC Diagnostika, represents a new dimension in the field of autoimmune diagnostics. It provides a fully automated process for the detection of autoantibodies with a degree of flexibility never before available.

With this system the user is able to conduct special diagnostic procedures tailored to the requirements of his facility. Each patient sample may be handled as an individual test and requires only minimal effort. This frees up new resources to benefit the patient.

This latest development, produced in close cooperation with specialists both in Germany and abroad, is another milestone in the long history of successes by ORGENTEC Diagnostika, and its high quality allows it to fit seamlessly into the existing product line.

Overview of the system’s most important advantages:

  • Automatic analytical system
  • Unrestricted sample selection, individual test parameters
  • SMC® Technology – Sensotronic Memorized Calibration
  • Stable and reproducible test conditions guaranteed by a temperature-controlled incubation unit
  • Over 100 test systems available
  • Each test run may include up to 30 patients with individual results delivered in only 90 minutes
  • Each result is validated by its own standard
Alegria® 2 - Customized panels for better patient care

Alegria® 2 - Customized panels for better patient care

Alegria® 2 – Any assay, any time!

ORGENTEC offers the market’s broadest autoimmune panel, combined with specialty infectious disease, stool inflammation markers and bone metabolism assays. – The fully automated Alegria® 2 instrument is the key to this wide range of test kits.

Alegria® 2 provides a sample-to-result solution utilizing ORGENTEC’s unique and comprehensive Alegria® Monotest portfolio with more than 100 parameters.

The complete product range of Alegria® assays is planned to be available on the new Alegria® 2 instrument by the end of 2022.

The flexibility to run any test from the large ORGENTEC portfolio at any time characterises the Alegria® system. Tailor-made biomarker profiles can be analysed for individual patients based on the requirements of the requesting physician – for optimal patient care.

Key advantages:

  • Fully automated analytical instrument with walk away design
  • Random access of primary tubes, STAT samples and Alegria® assays
  • Continuous loading option with high throughput of up to 240 tests in ~8 hours
  • Customised testing, based on patient needs: access to the complete Alegria® assay portfolio planned by the end of 2022
  • One test strip for one patient sample, each result is validated by its own integrated calibrator and control