What is it about?

We have carried out a comparison of a new rapid kit for the measurement of adalimumab (ADA) serum levels (Quantum Blue) with two ELISA kits (Promonitor and Lisa-Tracker) in samples from patients with inflammatory bowel disease (IBD) under ADA therapy. This is one of the first studies published as a full research paper comparing the performance of Quantum Blue rapid method for ADA determination with commercially available ELISA kits to check the interchangeability of results between these different methods.

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Why is it important?

Recent evidences showed that high ADA serum levels correlated with clinical response and mucosal healing in patients with IBD. Therefore, several commercial methods have been developed to determine ADA serum concentrations in clinical laboratories, being ELISA kits the most widely employed method currently. In addition, point-of-care tests (POCT) based on lateral flow immunochromatography have been also launched to the market in 2018, with the aim to overcome ELISA limitations. These rapid assays have the main advantage of providing results within minutes, allowing faster clinical decision making, and thus, they have a great potential of implementation in the near future. However, it is important to assess if results provided by rapid assays are interchangeable with other methods. In this study, we have found that although quantitative differences existed between the Quantum Blue assay and ELISA kits that hampered their interchangeability, the agreement for identifying patients with subtherapeutic values of ADA was high.

Perspectives

We believe that this paper is of great interest because monitoring of anti-TNFα drugs is a field gaining increased attention due to its usefulness to detect loss of response to the treatment, with the consequent benefits for patients and health-cost savings. Many specialists in Laboratory Medicine perform ADA serum level determinations routinely and they could have the possibility of switching from ELISA kits to rapid POCT assays, so we think they should have access to comparative studies between both methodologies that could help them to take adequate decisions for interpretation of results.

Emilio J Laserna Mendieta
Hospital General de Tomelloso

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This page is a summary of: Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits, Clinical Chemistry and Laboratory Medicine (CCLM), May 2019, De Gruyter, DOI: 10.1515/cclm-2019-0202.
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