(2) COMPARATIVE AGREEMENT ANALYSIS OF A CLASSICAL LAB-BASED ASSAY AND A MOBILE PHONE-BASED QUANTITATIVE PATIENT SELF-TEST
Författare/Medförfattare
Helene Solhaug, Ali Qamar (presenting author), Kris Sikorski, Mona Schartum, Line Tommerup, Einar Moerk.
Affiliates
All authors are employees at Calpro AS.
Abstract
Introduction: Several treatment guidelines and published clinical consensus studies recommend using fecal Calprotectin as a
monitoring tool for IBD. Available analysis methods range from well-established laboratory analysis methods to more recently
developed rapid methods for remote monitoring and point of care. Since there is no international reference for calprotectin, an
established agreement between different assay platforms is needed to use them interchangeably. Ideally the assays from the same
manufacturers should measure fecal calprotectin equally, although this is not always the case. This study compares fecal calprotectin measurements from two different assay platforms from the same manufacturer.
Aims & Methods: 131 fecal samples from IBD patients were measured using CalproLab ELISA ALP (CALP0170) and CalproSmart
Self-Test for remote monitoring of IBD. All fecal samples were extracted and analysed in parallel according to the kit-specific
instructions given by the manufacturer, requiring individual sample collection and extraction methods for both assays. 64 samples
covered the linear range for the assays and were included in the method comparison analysis.
Results: When comparing the two analysis methods, the slope and intercept values of 0,92 and 4,44 mg/kg respectively suggest that there is no significant difference between the two methods within their common linear range. This includes all relevant clinical cut-off values for the two methods. Furthermore, the relative difference between the two assays ranges from -1,9% to -6,8% at selected calprotectin values.
Conclusion: CalproSmart and CalproLab ELISA ELISA platforms measure fecal calprotectin levels equally, indicating that they can be used interchangeably without affecting the reliability of the results..
Disclosure: All authors are employees at Calpro AS. Experiments performed at Calpro R&D lab.
