The first IVDR sIL-2R ELISA

We’re excited to announce the availability of the sIL-2R ELISA kit (30201813), which is fully compliant with IVDR requirements, offering a reliable tool for sarcoidosis diagnostics. The kit has been CE marked under the European IVD Regulation 2017/746, ensuring you receive the most accurate and trustworthy results.

sIL-2R levels can be used as physiological marker for the indication of inflammation in the body, in-vivo immune system activation and response activity. As such the measurement of sIL-2R levels can be applied as an aid in the diagnosis or monitoring of therapy of autoimmune diseases (e.g. sarcoidosis).
Measuring levels of sIL-2R in adults are considered as a good parameter to determine on-going immune response, which can be used to monitor immune mediated diseases1.
This property is taken into account by several clinical guidelines. The German Society of Nephrology together with the German Clinical Chemistry and Laboratory Society recommend to measure sIL-2R together with other parameters in the diagnostic work-up of acute kidney failure to rule out a sarcoidosis origin2.
Furthermore, the German Ophthalmologic Society and the Professional Association of Ophthalmologists in Germany recommend in their clinical guidelines for optic neuritis also the measurement of sIL-2R to rule out a sarcoidotic background3. Another clinical guideline for the diagnostic of polyneuropathies from the German Society of Neurology also recommends to measure sIL-2R, if there is an indication of pulmonary involvement4.

Features of the sIL-2R ELISA (30201813):

• calibrated against NIBSC 97/600 standard preparation
• sufficient reagents for adaptation to different ELISA processors
• low and high kit control
• ready-to-use standard curve
• results reported in arbitrary U/mL
• first IVDR ELISA (based on Eudamed database search on Feb 23, 2024)

Your benefits:

• Trustworthy results: >95% specificity compared to established IVD solutions (N=216 from 7 different labs)
• Scalable solution: manual assay that can be easily automated (e.g. Thunderbolt®, DSX®, EVOlyzer®).

Bibliography:

1. Schimmelpennink, M. C., Quanjel, M., Vorselaars, A., Wiertz, I., Veltkamp, M., Van Moorsel, C., & Grutters, J. C. (2020).
   Value of serum soluble interleukin-2 receptor as a diagnostic and predictive biomarker in sarcoidosis.
   Expert review of respiratory medicine, 14(7), 749–756.
   DOI: 10.1080/17476348.2020.1751614
   PubMed ID: 3224870
2. DGKL) DGfrNDDGfrKCuLeV.
   Interdisziplinaere S2k-Leitlinie: Rationelle Labordiagnostik zur Abklaerung Akuter Nierenschaedigungen und Progredienter Nierenerkrankungen: Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF); 2021
3. DOG/BVA.
   S2e-Leitlinie: Optikusneuritis: Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V. (AWMF); 2018
4. Heuß D. et al.
   Diagnostik bei Polyneuropathien, S1-Leitlinie, 2019, in: Deutsche Gesellschaft für Neurologie (Hrsg.), Leitlinien für Diagnostik und Therapie in der Neurologie.