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Test Category: Specialist Biochemistry

Investigation Name:Infliximab Therapeutic Drug Monitoring

Alias or Abbreviation:Remicade

Accreditation:UKAS ISO15189:2022 accredited test: On scope

Intro:

Infliximab (Remicade®) is a chimeric human-mouse monoclonal antibody directed against tumour necrosis factor-alpha (TNF-α), approved for use in the treatment of various chronic inflammatory diseases including rheumatoid arthritis, severe Crohn’s disease and ankylosing spondylitis.
Infliximab is administered as an infusion with a dosing interval ranging from 2 to 16 weeks. Infusion of a standard dose of Infliximab leads to highly variable inter-individual serum drug concentrations partly due to the development of anti-Infliximab antibodies that bind to Infliximab leading to loss of therapeutic effect.
Therapeutic drug monitoring of Infliximab allows optimisation of treatment by ensuring serum trough drug levels are within the therapeutic range and also identifies patients who have developed a loss of response, potentially through development of anti-drug antibodies.

Requestable Seperately?Yes

Expected Turnaround Time:7 working days

Test Code:IFXL

Sample Type:

1ml serum. Minimum serum volume required: 200µl.

Complex Reference Range:Infliximab level >1 μg/mL is regarded as therapeutic
Infliximab level ≤1 μg/mL is regarded as sub-therapeutic.

Collection Conditions / Other Information:Infliximab levels should be measured as a trough sample (i.e. just before the next infusion is given).
The therapeutic cut-off used only applies to patients on maintenance Infliximab therapy.
To aid interpretation of results, it is essential that the following information is included on the request form:
- Infusion dosing interval
- Number of infusions to date
- Reason for request, i.e., not responding
- Primary diagnosis

Referred to Another Laboratory?No

Storage Requirements:2-8 °C prior to postage

Posting Address / Requirements:Ambient temperature,1st Class Post,
Sandwell Health Campus,
Specialist Chemistry,
Pathology Department
Lyndon, B71 4HJ

NPEX / PDF Reporting Available:Yes

EQA Scheme:Currently no EQA scheme is available. We participate in a quarterly sample share scheme alongside The Royal Devon & Exeter NHS Trust and Protein Reference Unit, Sheffield.

Lead Contact Details:Consultant Clinical Scientist, Hayley Sharrod-Cole,
Email: hayley.sharrod-cole@nhs.net

Email Address For Chasing Results:rwh-tr.bcpsspecialistchemistryenquiries@nhs.net

Site Sample Tested:Manuals Laboratory- Sandwell Health Campus

Cost:Please email: bcpspathology.info@nhs.net for further details

Contact Number:0121 507 5162