Analytical and clinical performance evaluation of two POC tests for therapeutic drug monitoring of infliximab.

ABSTRACT

Background Infliximab (IFX) is an effective therapy in patients with inflammatory bowel disease. Serum IFX trough concentrations correlate well with clinical, biological and endoscopic outcomes. Therefore, therapeutic drug monitoring (TDM) of infliximab is useful for dose optimization and prevention of secondary treatment failure. In the present study, analytical and clinical performance of two point-of-care (POC) tests, RIDA®QUICK IFX Monitoring assay (R-biopharm) and Quantum Blue® Infliximab assay (Bühlmann), have been evaluated and compared to our established enzyme-linked immunosorbent assay (ELISA) (apDia IFX ELISA). Methods Analytical performance was assessed according to the CLSI EP5-A2 protocol using the manufacturer's kit controls and different serial dilution series. Method comparison with our established ELISA was done using a wide range of consecutive patient samples (n=180). Clinical concordance was evaluated by categorization based on well-known therapeutic cut-off points (3-7 µg/mL). Results The analytical performance of both POC tests was inferior to the established ELISA, but acceptable based on the manufacturer's quality claims. Eight-point serial dilution confirmed the analytical performance data in the low-level measuring range. Eleven-point serial dilution demonstrated linearity for both POC tests over the studied concentration range. Method comparison with the ELISA showed significant negative proportional bias for the RIDA®QUICK IFX Monitoring assay. However, good correlation and clinical concordance were shown. Quantum Blue® Infliximab assay showed a significant positive proportional and a negative systematic bias in comparison with the ELISA, resulting in overestimation of IFX levels with impact on clinical concordance data. Conclusions Both POC tests have their own specific benefits and drawbacks but are suitable for therapeutic drug monitoring of IFX. However, long-term monitoring of IFX trough levels requires measurement of IFX concentrations with the same assay.