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

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The Infliximab ELISA is based on a sandwich enzyme immunoassay technique with a Infliximab 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 (Infliximab) 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 Infliximab treatment has both clinical and economic advantages because not all patients respond equally to Infliximab.

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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.

IDKmonitor® assays from BIOHIT HealthCare are highly specific for the target drug and are used widely for routine clinical and research applications. The IDKmonitor® Infliximab 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 anti-TNFα therapy withdrawal

• Predict efficacy of re-initiating therapy after drug holiday

• Direct the switching to Biosimilars or another class of drug

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The IDKmonitor® Infliximab Drug Level ELISA is for the quantitative determination of free therapeutic TNFα antibodies(Infliximab (e.g. REMICADE®, Remsima®, Inflectra®)) in EDTA plasma and serum. The assay detects and quantifies free infliximab from a sample by capturing it using specific monoclonal anti-infliximab antibody that coats the plate.

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The assay is well established throughout the UK and Ireland in both routine clinical laboratories as well as being used for research applications.

• Quantifies free Infliximab drug levels in Serum and Plasma

• Microplate coated with highly specific anti-Infliximab Ab

• Compatible with biosimilars (e.g. Inflectra®, Remsima®)

• 6 calibrators, 2 controls

• Capacity for 40 samples in duplicate

• Reportable range 4.15-225 ng/ml

• Total incubation time 130 minutes

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

• Highly specific quantification of Infliximab

• Helps predict Primary non-response, loss of response, non remission

• No cross reaction with adalimumab, golimumab other plasma proteins

• UK publications and evidence base

• Widely available via reference laboratories in UK and Ireland

• Validated for biosimilars

• Applicable to Gastroenterology, Rheumatology