The BioVendor Group CLIA brand has arrived through the cooperation of companies within this biotechnology group based in Brno, Czech Republic. Their development and manufacture of diagnostic kits for the new KleeYa® analyzer from Diatron has created an automated, entirely European solution using a modern chemiluminescence method - CLIA. In recent years CLIA has won recognition in the diagnostic world, replacing traditional methods such as ELISA and RIA thanks to the reduction in measurement time and automation.

The collaboration between BioVendor R&D development division for innovative biomarkers and technologies, engaged in research since 1995, and TestLine, a manufacturer of IVD products for infectious diseases and immunology since the 1990’s, has been strengthened by the knowledge and experience contributed by DiaSource in the diagnostic fields of endocrinology and autoimmune disease. 

This fully automated solution combines experience in developing and producing diagnostic kits from individual BioVendor Group associates. The quality of the instrument is guaranteed by the established manufacturer Diatron, which belongs to the Stratec portfolio.

The future is personalized diagnostics

“We are putting the best of the collective tradition of all BioVendor Group companies into the new, automated solution. Both from a tangible point of view, where diagnostic tests can be mentioned, but also from the intangible point of view, where I would like to highlight decades of experience in cooperation and care for our customers,” comments Michal Kostka D.V.M, CEO of BioVendor Group.

Test panels are compiled by specialists into specific groups

The cooperation of companies from several fields enables the BioVendor Group to compile specific panels and design the composition of assays for much more complex testing and offer patients meaningful multidisciplinary diagnostics. The BioVendor Group CLIA solution is suitable for both smaller and large laboratories, in which it will complement the existing portfolio. To smaller workplaces it brings automation and the ability to test a number of parameters quickly in response to immediate needs. 

Successful solution development also thinks about innovation. The BioVendor Group CLIA solution has the advantage of augmented reality service support, allowing you to solve user problems immediately without the need to wait for the arrival of a technician. The customer line offers clients support 24 hours a day.

Testing of unique parameters

BioVendor Group develops unique parameters that differentiate this solution from others on the market. The goal is to provide laboratories with instrument and diagnostic kits as a fine-tuned system that will facilitate the diagnosis of individual diseases effectively.

Due to the complexity, they can, for example, find out from one sample whether the test subject is infected with one type of disease and point out a possible initial stage of another illness. One such unique parameter is MxA which has more than one application. In vulnerable individuals such as newborn infants, MxA can be used to identify potentially dangerous viral infections of the upper respiratory tract. In patients with multiple sclerosis or Sjögren's syndrome, it may indicate a reduced effectiveness of treatment and thus prevent an irreversible deterioration in their health.

Thanks to the development, BioVendor Group expands testable parameters 

BioVendor Group is gradually expanding individual clinical testing with new parameters. The present solution focuses on infectious diseases, including COVID-19, sepsis and inflammation, immunological and autoimmune diseases, as well as fertility and endocrinology. Connecting test parameters from specific clinical areas will provide a more comprehensive picture of the health of each individual. The BioVendor Group CLIA development pipeline will result in diagnostic kits for the KleeYa® platform in clinical areas including cardiovascular disease, diabetes and metabolic disorders, bone and cartilage metabolism or kidney disease and oncology.

Unique parameters will also be introduced

The BioVendor Group is developing and certifying individual diagnostic kits CE IVD, and the number of unique and routinely established parameters will increase progressively. At this moment, laboratories can monitor the antibody response to COVID-19 infection and the effectiveness of vaccination against the disease using the CLIA solution from the BioVendor Group. In addition, other parameters will be added for areas of sepsis and inflammation or infectious serology. However, the development of the BioVendor Group does not end there. “Laboratory diagnostics is one of the fields where automation and consolidation is on the rise, so we also want to continue to participate in the development of modern diagnostic methods and thus benefit from the many years of experience of companies belonging to the BioVendor Group,” adds Kostka.

CLIA method

The CLIA immunoassay uses magnetic particles to separate the immunocomplex with a selected antigen or antibody easily and fast. The detection system uses flash chemiluminescence of acridinium ester and the intensity of the light flash is measured in relative light units (RLU).

BioVendor Group CLIA

Under the BioVendor Group CLIA brand, the BioVendor Group presents a comprehensive solution for diagnostics. It combines the experience of members of the group BioVendor R&D, TestLine, DiaSource with a modern, fully automated and European-made KleeYa® device from the manufacturer Diatron. It belongs to the portfolio of the market leader Stratec.

KleeYa® platform

The KleeYa device is characterized by high sensitivity and a large sample processing capacity. KleeYa® offers an economical alternative for the quantitative measurement of antigens and antibodies in body fluids. The device uses chemiluminescent immunoassays from BioVendor Group laboratories for CLIA method analysis.

About BioVendor Group

BioVendor – Laboratorní medicína a.s. was founded in 1992 by Viktor Růžička. Since 2017, the shareholder of the BioVendor Group is Consillium - Tomáš Němec's family company, for which medical diagnostics, together with sport and sustainable agriculture, is a key investment area. 

BioVendor Group is an international group of biotechnology companies with their research, development, production of in vitro diagnostic products (IVD) and sales network. Since its founding in 1992, the originally small Brno company with several employees has been transformed into a multinational group, including several global branches, its own R&D division (development center) and also established brands TestLine, DiaSource, ViennaLab and Oxford BioSystems. The unique width of the portfolio ranks the BioVendor Group among the major players in the global diagnostic market.