Evidence-based recommendations on therapeutic monitoring of tumour necrosis factor (TNF)‑alpha inhibitors (LISA‑TRACKER, IDKmonitor and Promonitor ELISA kits) in people with Crohn’s disease.

During development of this guidance, NICE became aware that the RIDASCREEN IFX Monitoring (R-Biopharm) ELISA kit for monitoring infliximab levels received a CE mark. This new test is based on the Leuven in-house ELISA. For further information please see NICE’s medtech innovation briefing on RIDASCREEN tests for monitoring infliximab in inflammatory bowel disease.

Guidance development process

How we develop diagnostics guidance

Your responsibility

This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.

Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.

Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

  • National Institute for Health and Care Excellence (NICE)