The CALEX® Effect White Paper - Buhlmann Diagnostics Corp

The CALEX® Effect White Paper

The CALEX® Cap Stool Preparation Device, through its proprietary extraction process known as the CALEX® Effect, supports the efficiency of calprotectin extraction from stool. This article covers data from a multicenter study supporting our 510(k) submission for BÜHLMANN fCAL® ELISA and turbo as well as essential peer-reviewed articles using the assays in real-world studies. The published and peer-reviewed real-world evidence studies demonstrate that BÜHLMANN fCAL® turbo, powered by the CALEX® Effect, delivers high sensitivity and diagnostic accuracy. These findings highlight the critical role of extraction efficiency in diagnostic sensitivity and reinforce BÜHLMANN’s commitment in providing more accurate, clinically meaningful, and actionable results.1-6

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  1. BUHLMANN Laboratories AG, US202200240994A1, Method for Determination of a Protein. [US], Patent, Filed [Apr 10, 2020], Issue [July 30, 2020].
  2. Reinhard et al. (2026). Clinical Evaluatio and method comparison of four fecal calprotectin assays. JCC ECCO Poster Abstract https://doi.org/10.1093/ecco-jcc/jjaf231.600 and DDW 2026 Poster Abstract.
  3. Oyaert, M., Van den Bremt, S. et al. Do not forget about pre-analytics in faecal calprotectin measurement! Clinica Chimica Acta. 2017 Oct; 473:124-126.
    doi:10.1016/j.cca.2017.08.025. PMID: 28847684.
  4. Oyaert, M., et al. “Analytical performance and diagnostic accuracy of six faecal calprotectin assays…” Clin Chem Lab Med, 2017.
  5. De Sloovere MMW, De Smet D, Baert FJ, Debrabandere J, Vanpoucke HJM. Analytical and diagnostic performance of two automated fecal calprotectin immunoassays for detection of inflammatory bowel disease. Clin Chem Lab Med. 2017;55(9):1435‑1446. doi:10.1515/cclm-2016-0796
  6. Oka, A., Kawashima, K., Kishimoto, K. et al. Validation of rapid fecal calprotectin assay using particle enhanced turbidimetric immunoassay for inflammatory bowel disease. Sci Rep 14, 1653 (2024). https://doi.org/10.1038/s41598-024-51580-z