Analytical and clinical performance of the fully-automated LIAISONXL calprotectin immunoassay from DiaSorin in IBD patients.

Objectives: Distinction between inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) based on clinical symptoms is often difficult. In this study we assessed the performance of the fully-automated calprotectin immunoassay from DiaSorin in IBD diagnosis and follow-up and compared it to the EliA calprotectin 2 immunoassay.

Design: and Methods: The calprotectin immunoassay from DiaSorin run on the LIAISONXL was analytically and clinically validated and compared to the EliA calprotectin 2 immunoassay from Thermo Fisher Scientific run on the ImmunoCAP250. Five patient groups were measured (n ​= ​303): IBD: ulcerative colitis (UC) and Crohn's disease (CD); non-IBD: IBS, other gastrointestinal diseases and controls (healthy patients with no gastrointestinal disease).

Results: The calprotectin immunoassay of DiaSorin showed good analytical performance with frozen samples. The presence of blood in the stool can interfere with the measurement of calprotectin. Patients suffering from IBD (UC or CD) showed significant higher concentrations of fecal calprotectin compared to controls (UC:710 ​± ​921 ​mg/kg; CD:967 ​± ​1243 ​mg/kg; controls:11±8 ​mg/kg) using DiaSorin's immunoassay. The remaining non-IBD groups showed no significant difference compared to controls. Follow-up patients (n ​= ​9) showed a significant decrease in fecal calprotectin after treatment. At 50 ​mg/kg cut-off value, the negative predictive value for DiaSorin's immunoassay was 96% and the positive predictive value 83% (sensitivity of 95% and specificity of 86%).

Conclusions: The lack of standardization contributes to the numerical differences between the two methods, but the qualitative conclusions do not differ. DiaSorin's calprotectin immunoassay can be used both to distinguish between IBD and non-IBD patients as well as for follow-up of IBD patients.