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Test ID BLOD1339 Infliximab Quantitation with Reflex to Antibodies to Infliximab, Serum

Useful For

Trough level quantitation for evaluation of patients undergoing therapy with infliximab, with signs and symptoms of loss of response to therapy.

Specimen Type

Serum Red


Specimen Required


Patient Preparation:

1. Draw blood immediately before next scheduled dose (trough specimen).

2. For 12 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial within 2 hours of collection.


Specimen Minimum Volume

0.5 mL

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus Reject

Specimen Stability Information

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

Day(s) Performed

Monday through Friday

Report Available

3 to 6 days

Method Name

INFXR, INFX: Selective Reaction Monitoring Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

INXAB: Electrochemiluminescent Bridging Immunoassay with Acid Dissociation

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

80230

82397-(if appropriate)

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 liquid chromatography-tandem mass spectrometry on all specimens. When infliximab results are below 5.1 mcg/mL, testing for antibodies to infliximab will be performed at an additional charge.

 

For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm

Reporting Name

Infliximab QN with Reflex to Ab, S

Reference Values

INFLIXIMAB QUANTITATION:

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

 

Pediatric reference ranges are not established.

 

INFLIXIMAB ANTIBODIES

Absence of antibodies to infliximab (ATI) is defined as <50 U/mL

Presence of ATI is reported as positive when concentrations are ≥50 U/mL

Test Classification

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

Forms

If not ordering electronically, complete, print, and send 1 of the following with specimen:

-Gastroenterology and Hepatology Test Request (T728)

-Therapeutics Test Request (T831)

-General Request (T239)

Sanford Laboratories - Fargo Additional Information:

SANFORD INTERFACE BUILD INFORMATION

Result Code Result Code Description
18564 Infliximab, S
18565 Interpretation