CSF diagnostics means the analysis of the fluid that circulates in the brain and the bone marrow (liquor cerebrospinalis, cerebrospinal fluid). It is a valuable tool to detect acute or chronic inflammatory processes in the central nervous system (CNS). The cause of such often severe diseases of the CNS may be infections with bacteria (e.g. Borrelia), viruses, (e.g. measles or tick-borne encephalitis virus), or parasites (e.g. Toxoplasma gondii). However, also non-infectious diseases, such as multiple sclerosis, may lead to damages of the CNS.
The detection of specific antibodies that are produced directly in the CSF (=intrathecally) indicates whether an infection is the underlying cause of the respective symptoms, such as encephalitis or inflammation of the brain, and, if this is the case, what kind of infection is present.
EUROIMMUN offers a broad range of CE-marked products for CSF diagnostics that have now been optimised within the transition of the old guidelines (98/79/EG on in-vitro diagnostics, IVDD) to the new European Regulation on In Vitro Diagnostics ((EU) 2017/746, IVDR). These optimisations facilitate the handling of the assays and save resources. The products of the new “CSF ELISA 2.0” series are the result of these optimisations.
New features of the new “CSF ELISA 2.0” products
- The conventional test kits for CSF diagnostics not only contained calibrators for CSF analyses, but also components (calibrators, controls) for the corresponding serology. Since the latter are no longer included in the kit format, the kits are more streamlined. This optimisation also helps to reduce waste as the serology components have often remained unused.
- Instead, the test kits of the new CSF ELISA 2.0 series contain lot-specific CSF/serum control pairs. Until now, these had to be ordered separately. The use of the control pairs ensures the validity of the test runs.
- Now, the sample buffer included in the test kit can generally be applied for the automatic processing of the “CSF ELISA 2.0” and the separately available CSF sample buffer is no longer required.
The Anti-TBE Virus CSF ELISA 2.0
The Anti-TBE Virus CSF ELISA 2.0 (IgG) was the first of its kind to be declared as IVDR compliant last autumn and to be placed on the market with all optimised features of the CSF ELISA 2.0 series.
Shortly before, the Anti-TBE Virus ELISA 2.0 (IgG) had been declared IVDR compliant and launched as the first newly developed product of IVD risk class B. Further ELISAs for the detection of IgM antibodies against tick-borne encephalitis virus (TBE virus) are already undergoing revalidation procedures for conformity assessment according to the IVDR. Consequently, a complete portfolio of IVDR-compliant products for TBE virus diagnostics will be available.