Therapeutic Drug Monitoring
CONTEXT
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Infliximab (IFX) is a monoclonal antibody used in therapy of patients with moderate-to-severe inflammatory bowel disease (IBD). Monitoring the IFX trough concentration (i.e. the lowest IFX concentration immediately prior to next infusion) is recommended for enhancing the therapeutic outcome of IBD patients, which is mostly done using enzyme linked immunosorbent assay (ELISA) or the faster, but less sensitive lateral flow-based immunoassay.
Some disadvantages make current analysis techniques unsuitable at the point of care (POC): (i) the need for serum samples, requiring patients to come to a hospital, (ii) requirement for well-trained staff, (iii) relatively long time-to-result (approximately 2 hours) and (iv) the need for multiple patient samples to be collected in a central laboratory. Thus, immediate dose adaption is impossible. |
FOx SOLUTION
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Fox Biosystems presents an inexpensive platform that allows for single sample testing. The advanced IFX immunoassay has 3 distinct features:
(i) fast assay time (10 min.), (ii) clinically relevant sensitivity (0.97 – 80 ng/mL in 100 times diluted sample) (iii) capacity for detecting IFX in various matrices with minimum sample preparation (serum, plasma and whole blood). |
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The developed immunoassay was validated on different days using independently prepared consumables without statistical significance. These results demonstrated that a new calibration curve is unnecessary for each batch.
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The final validation of the POC FO-SPR immunoassay was performed with 10 clinical samples from IFX-treated IBD patients, being five matching serum and plasma samples from the same five patients. The measured IFX concentrations were compared to the values obtained using clinically validated ELISA, revealing excellent agreement between two methods, with the Pearson correlation and ICC of 0.999 and 0.998, respectively for serum samples, and 0.979 and 0.992, respectively for plasma samples.
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FULL ARTICLE
https://www.ncbi.nlm.nih.gov/pubmed/28222600
CONCLUSION
In conclusion, the FOx Biosystems biosensor offers fully automated set-up, single sample access and rapid detection. The fact that the same platform can sensitively detect IFX in variety of matrices, such as serum, plasma and whole blood, with clinically relevant sensitivities in 10 minutes demonstrated that the FO-SPR biosensor is a versatile POC diagnostic tool.