Skip to main content

Infliximab and Anti-Infliximab Antibody, DoseASSURE™ IFX

CPT

80230; 82397

Synonyms
  • Anti-TNF-alpha Drug
  • DoseASSURE
  • IFD
  • Remicade

Test Details

Methodology

Electrochemiluminescence Immunoassay (ECLIA)

Result Turnaround Time

5 - 10 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Test Includes

This test includes serial monitoring.

Use

Provides infliximab drug concentration levels as well as levels of anti-infliximab antibodies.

In the absence of anti-infliximab antibodies, the infliximab drug level typically reflects the total infliximab concentration in serum. In the presence of anti-infliximab antibodies, the infliximab drug level typically reflects the antibody-unbound fraction of infliximab concentration in serum. The presence of infliximab drug, even at concentrations well above target treatment levels (>50 ug/mL), does not interfere with the anti-infliximab antibody detection. This assay may be helpful for any patients on infliximab therapy for diseases such as Crohn's disease, inflammatory bowel disease, ulcerative colitis, rhematoid arthritis, or other autoimmune conditions. This test includes long-term serial monitoring of results.

Limitations

Failure of infliximab therapy may not always be due to the presence of anti-infliximab antibodies. In addition, the absence of anti-infliximab antibodies does not guarantee positive response to treatment.

Specimen Requirements

Specimen

Serum (preferred) or plasma

Volume

2 mL

Minimum Volume

1 mL (Note: This volume does not allow for repeat testing).

Container

Red-top tube, gel-barrier tube or plasma from green-top tube

Collection Instructions

Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit separate frozen specimens for each test requested.

Stability Requirements

TemperaturePeriod
Room temperature7 days
Refrigerated7 days
Frozen359 days
Freeze/thaw cyclesStable x6

Storage Instructions

Frozen (preferred) or refrigerated

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
503870 Infliximab Drug + Antibody 503772 Infliximab Drug Level ug/mL 39803-2
503870 Infliximab Drug + Antibody 503773 Anti-Infliximab Antibody ng/mL 72623-2
Order Code503870
Order Code NameInfliximab Drug + Antibody
Order Loinc
Result Code503772
Result Code NameInfliximab Drug Level
UofMug/mL
Result LOINC39803-2
Order Code503870
Order Code NameInfliximab Drug + Antibody
Order Loinc
Result Code503773
Result Code NameAnti-Infliximab Antibody
UofMng/mL
Result LOINC72623-2
Reflex Table for Anti-Infliximab Antibody
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 504107 Serial Monitoring 000000 Serial Monitoring N/A
Reflex 1
Order Code504107
Order NameSerial Monitoring
Result Code000000
Result NameSerial Monitoring
UofM
Result LOINCN/A
Reflex Table for Anti-Infliximab Antibody
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 504107 Serial Monitoring 511958 PDF 80563-0
Reflex 1
Order Code504107
Order NameSerial Monitoring
Result Code511958
Result NamePDF
UofM
Result LOINC80563-0