A novel turbidimetric immunoassay for fecal calprotectin optimized for routine chemistry analyzers

摘要

Background Fecal calprotectin assays are widely used to exclude inflammatory bowel disease ( IBD ) in patients with suspected IBD . A problem with the fecal calprotectin assays is the rather long test‐turnaround times. A particle enhanced turbidimetric immunoassays ( PETIA ) for fecal calprotectin would reduce test‐turnaround times and would permit more laboratories to perform the measurements. The aim of this study was to evaluate a new feces calprotectin PETIA . Method Using routine fecal samples the feces calprotectin PETIA was validated on two chemistry analyzers, Mindray BS ‐380 and Cobas 501. Results The assay is linear in the range 11–2000?μg/g, with a limit of quantitation of approximately 10?μg/g. No antigen excess hook effect was observed up to 10?000–15?000?μg/g depending on the instrument used. The turbidimetric method showed a good agreement with the Bühlmann ELISA . The total coefficient of variation was 3%–8% in the 50–100?μg/g range. Conclusion The fecal calprotectin PETIA , fC al Turbo, is well suited for rapid analysis of fecal calprotectin on Mindray BS ‐380 or Cobas 501 clinical chemistry analyzers. The test results are commutable with Bühlmann fecal MRP 8/14 ELISA .