Measurement of Serum Antibodies to Selected Biologic Agents

Section: Laboratory
Effective Date: January 01, 2020
Last Reviewed: December 12, 2019


Tumor necrosis factor (TNF) inhibitors (e.g. infliximab, adalimumab, vedolizumab, or ustekinumab) are used to treat multiple inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis; inflammatory bowel disease (e.g., Crohn disease, ulcerative colitis), ankylosing spondylitis, and plaque psoriasis. These agents are generally given to individuals who fail conventional medical therapy, and they are typically highly effective for the induction and maintenance of clinical remission.


Measurement of antibodies to tumor necrosis factor (TNF) blocking agents in a individual receiving treatment with a TNF blocking agent, either alone or as a combination test, which includes the measurement of serum TNF blocking agent levels, is considered investigational

Procedure Codes

80145 80230 80280 84999

Diagnosis Codes

Not Applicable

Professional Statements and Societal Positions Guidelines

Practice Guidelines and Position Statements

American College of Gastroenterology Institute

The American College of Gastroenterology Institute (2017) published guidelines on therapeutic drug monitoring in inflammatory bowel disease. The guidelines note that

“When anti-drug antibodies are detected, it is unclear what antibody level is clinically meaningful…. the reporting of anti-drug antibodies is variable between commercial assays, with some assays being very sensitive for detecting very-low-titer antibodies of limited clinical significance. Uniform thresholds for clinically relevant antibody titers are lacking. At this time, it is unclear how antibodies affect drug efficacy when both active drug and antibodies are detected. In cases of low trough concentrations and low or high anti-drug antibodies, the evidence to clarify optimal management is lacking.”

The guidelines did not address therapeutic drug monitoring in individuals treated with vedolizumab or ustekinumab.

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (2016) issued guidance on therapeutic monitoring of tumor necrosis factor α inhibitors in the treatment of individuals with Crohn disease.The Institute recommended that laboratories monitoring tumor necrosis factor α inhibitors in individuals with Crohn disease who have lost response to the treatment should “work with clinicians to collect data through a prospective study, for local audit, or for submission to an existing registry.”

ND Committee Review

New code review 12-2019 New codes created replacing codes previously considered Experimental/Investigational.


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