First newly developed ELISA of risk class B declared IVDR-compliant

Anti-TBE Virus ELISA 2.0 (IgG)

After EUROIMMUN received the required certificate for its quality management system in accordance with the new European Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in May of this year, the first newly developed IVD product of risk class B has now also been declared IVDR-compliant and launched on the market: the Anti-TBE Virus ELISA 2. 0 (IgG). This is another important step in the transition from the old Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) to the new IVDR.

New features of the Anti-TBE Virus ELISA 2.0 (IgG)

The Anti-TBE Virus ELISA 2.0 (IgG) replaces the two previously offered ELISAs, the Anti-TBE Virus ELISA (IgG) and Anti-TBE Virus ELISA “Vienna” (IgG), and combines the previously different result evaluation in one test system. The new ELISA allows quantification of IgG antibodies against tick-borne encephalitis virus (TBE virus) both in relative units (RU/ml) and in so-called Vienna units (VIEU/ml).

Vienna units were first introduced in Vienna in the 1980s to evaluate the efficacy of the first approved TBE vaccine. They do not represent an international standard but are considered an unofficial reference unit that is often used in clinical practice to draw conclusions about possible immune protection based on the individual TBE-virus-specific IgG antibody concentration. A conversion of the obtained results from relative units to Vienna units is – unlike with the predecessor products – now possible with the new Anti-TBE Virus ELISA 2.0 (IgG).

In comparison to the former Anti-TBE Virus ELISA (IgG), the new assay also includes an additional calibrator (4 calibrators in total), which allows more precise concentration determinations. The incubation scheme was also adapted to the scheme of other ELISAs for flavivirus serology. This facilitates parallel processing of the Anti-TBE Virus ELISA 2.0 (IgG) with ELISAs for other parameters relevant for differential diagnosis (e.g. West Nile virus or Japanese encephalitis virus) on corresponding automation platforms.

Tick-borne encephalitis

TBE is an infectious disease caused by viruses that are transmitted to humans mainly via bites of infected ticks. The vaccine-preventable disease can run a severe course and is one of the most common viral diseases involving the central nervous system in Central and Northern Europe. Around the world, between 10,000 and 12,000 cases are reported annually (Epidemiological Bulletin 14/2023 ( In Germany, 178 districts are currently considered risk areas. Between 2021 and 2022, the number of registered TBEV infections raised by 30% to 546 cases. (RKI – Archiv 2023 – FSME-Risikogebiete in Deutschland (Stand: Januar 2023).

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