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Test ID INFXR Infliximab Quantitation with Reflex to Antibodies to Infliximab, Serum

Useful For

Trough level quantitation for evaluation of patients with loss of response to infliximab.

Profile Information

Test ID Reporting Name Available Separately Always Performed
INFX Infliximab, S No Yes

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
INXAB Infliximab Ab, S No No

Testing Algorithm

Infliximab will be performed by LC-MS/MS on all samples. When Infliximab results are below 5.1 mcg/mL, testing for antibodies-to-infliximab will be performed at an additional charge.

Method Name

Selective Reaction Monitoring LC-MS/MS

Reporting Name

Infliximab QN with Reflex to Ab, S

Specimen Type

Serum Red

Container/Tube: Red top

Specimen Volume: 1 mL

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Red Frozen (preferred) 28 days
  Refrigerated  28 days

Clinical Information

Infliximab (Remicade, Janssen Biotech) is a chimeric immunoglobulin (IgG1 kappa) targeting tumor necrosis factor-alpha (TNF-a), and is currently FDA-approved for the treatment of multiple inflammatory conditions. Infliximab binds to soluble TNF-a and transmembrane homotrimers.

 

Infliximab pharmacokinetic properties may vary with disease and clearance is affected by concomitant use of immunosuppressants, high concentrations of TNF-a and C-reactive proteins,(1,2) low albumin concentrations, high body mass index, and presence of antibodies-to-infliximab, also known as human antichimeric antibodies (HACA).(3) Males seem to clear infliximab faster than females.(3)

 

Several studies have demonstrated that infliximab quantitation in the setting of loss of response to therapy can aid in patient management, as trough concentrations defined as therapeutic have been associated with superior clinical response and improved prognosis.(4-6)

 

Reference Values

Limit of quantitation is 1.0 mcg/mL. Therapeutic ranges are disease specific.

Cautions

Pediatric reference ranges are not established.

 

Toxicity effects other than acute hypersensitivity infusion reactions have not been described nor correlated with infliximab concentrations

 

During the initial induction phase of treatment (weeks 0, 2 and 6), steady-state has not been achieved and concentrations of infliximab may vary significantly between infusions.(3)

 

Therapeutic concentrations of infliximab may vary according to the disease (eg, Crohn disease vs ulcerative colitis vs rheumatoid arthritis).

Day(s) Performed

Monday, Wednesday, Thursday, 4 p.m.

Report Available

3 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

80299

NY State Approved

Conditional