Test Category: Specialist Biochemistry
Investigation Name:Anti- Adalimumab Antibodies
Accreditation:New Assay as of July 2026- validated awaiting UKAS ETS
Intro:
Adalimumab (Humira®) is a humanised 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.A significant proportion of patients on Adalimumab go on to develop antibodies against the drug, which leads to a loss of therapeutic efficacy due to neutralisation of therapeutic effect and/or increased drug clearance and an increased risk of infusion reactions. Anti-Adalimumab antibodies are measured on all patient samples who report an Adalimumab drug level result of ≤5 µg/mL.
Anti-Adalimumab antibody analysis can also be performed on all samples by prior arrangement with the laboratory. Please contact us to discuss if required.
Pathology Laboratory:Manuals Laboratory
Requestable Seperately?Yes
Expected Turnaround Time:7 working days.
Sample Type:
1 mL serum. Minimum serum volume required: 200 µL.Complex Reference Range:Anti-drug antibodies ≥10 ng/mL are reported as ‘detected’
Anti-drug antibodies <10 ng/mL are reported as ‘not detected’.
Collection Conditions / Other Information:Anti-Adalimumab antibody levels should be measured as a trough sample (i.e. just before the next infusion is given).
Anti - Adalimumab 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 therapy.
The new assays measure free antibodies rather than total antibodies, and results will now be expressed in mass concentration units. They will not be numerically comparable to results prior to the assay change. Our ADA assays are not drug-tolerant, meaning results may be unreliable when high concentrations of drug are present.
Referred to Another Laboratory?No
Storage Requirements:Store at 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:Pilot UK NEQAS for Anti-TNF Drugs and Antibodies.
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
