Ordering Recommendation

Use to monitor infliximab or infliximab biosimilar therapy.

New York DOH Approval Status

Testing is not New York state approved. Specimens from New York clients will be sent out to a New York state-approved laboratory.

Specimen Required

Patient Preparation

Collect specimen before next scheduled dose of infliximab or infliximab biosimilar (trough specimen). Avoid exposure to biotin (vitamin B7) for 12 hours prior to specimen collection.

Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP. Transfer 1 mL serum to an ARUP standard transport tube. (Min 0.1 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Grossly hemolyzed, icteric, or lipemic specimens.

Remarks
Stability

After separation from cells: Ambient: 2 days; Refrigerated: 2 weeks; Frozen: 1 month (avoid repeated freeze/thaw cycles).

Methodology

Quantitative Electrochemiluminescence Immunoassay (ECLIA) with Acid Dissociation

Performed

Sun-Sat

Reported

3-7 days

Reference Interval

Test Number
Components
Reference Interval
  Infliximab Quantitation 0.5 ug/mL or greater
  Antibodies to Infliximab Quantitation 19 ng/mL or less

Interpretive Data

Infliximab Quantitation:

Results of 0.5 ug/mL or higher indicate the detection of infliximab or an infliximab biosimilar. Therapeutic level may vary depending on the disease being treated.

Antibodies to Infliximab Quantitation:

Results of 20 ng/mL or higher indicate the detection of antibodies against infliximab or an infliximab biosimilar. Interpret in the context of infliximab or infliximab biosimilar trough concentration to determine clinical significance and impact on treatment efficacy.

Compliance Category

Laboratory Developed Test (LDT)

Note

Hotline History

N/A

CPT Codes

80230; 82397

Components

Component Test Code* Component Chart Name LOINC
3016780 Infliximab Quantitation 86896-8
3016781 Antibodies to Infliximab Quantitation 86897-6
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Avsola
  • Inflectra
  • Ixifi
  • Remicade
  • Renflexis
Infliximab and Antibodies to Infliximab Quantitation