The IDKmonitor Vedolizumab Drug Level ELISA kit is a microplate-based quantitative enzyme linked immunosorbent assay (ELISA) for the determination of free Vedolizumab from plasma or serum samples.

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The Vedolizumab ELISA is based on a sandwich enzyme immunoassay technique with a Vedolizumab specific capture antibody adsorbed on a microplate and a detection antibody labeled with horseradish peroxidase (HRP).

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This test is intended to quantify the amount of free drug (Vedolizumab) to evaluate the efficacy of drug and to investigate Primary non-response and loss of response.

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Being able to stratify patients according to whether they are likely to benefit from their Vedolizumab treatment has both clinical and economic advantages because not all patients respond equally to Vedolizumab.

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Some patients will respond well with fewer symptoms with a reduction in inflammatory biomarkers (e.g. faecal calprotectin) and endoscopic scores, while others will fail to respond during the induction phase of treatment, or lose response over time.

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IDKmonitor® assays from BIOHIT HealthCare are highly specific for the target drug and are used widely for routine clinical and research applications. The IDKmonitor® Vedolizumab Drug Level ELISA helps:

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• Assess risk of and manage primary non-response

• Predict the long term outcome and identify loss of response

• Predict response to therapy withdrawal

• Predict efficacy of re-initiating therapy after drug holiday

• Direct the switching to another class of drug

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The IDKmonitor® ELISA for the determination of the drug level of Vedolizumab (e.g. ENTYVIO®) in EDTA plasma and serum measures free Vedolizumab quantitatively, giving the treating physician an opportunity to monitor and optimise therapy.

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The assay determines the quantity of free Vedolizumab (therapeutic antibody against α4β7) in EDTA plasma or serum samples by capturing the free (unbound) Vedolizumab using a specific monoclonal anti-Vedolizumab antibody that coats the plate.

• Quantifies free Vedolizumab drug levels in Serum and Plasma

• Microplate coated with highly specific anti-Vedolizumab Ab

• 5 calibrators, 2 controls

• Capacity for 41 samples in duplicate

• Reportable range 3-200 µg/ml

• Total incubation 130 minutes

• Automatable on ELISA automates (e.g. Dynex D2)

• Highly specific quantification of Vedolizumab

• No cross reactivity (<0.01%) with Infliximab, Adalimumab or Golimumab

• May helps predict Primary non-response, loss of response, non remission

• Available in the UK via several reference laboratories

• Applicable to Gastroenterology