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Etanercept and Anti-Etanercept Antibody (Serial Monitor), DoseASSURE™ ETN

CPT: 80299; 82397
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Synonyms

  • Anti-TNF
  • DoseASSURE
  • Enbrel®

Expected Turnaround Time

6 - 12 days



Specimen Requirements


Specimen

Serum (preferred) or plasma


Volume

3 mL


Minimum Volume

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


Container

Serum-gel tube, red-top tube, lavender-top (EDTA) tube, or green-top (heparin) tube


Collection

Serum/plasma must be separated from cells within 45 minutes of venipuncture. Submit serum/plasma 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.


Storage Instructions

Refrigerate or freeze. Stable at room temperature or frozen for 14 days. Freeze/thaw cycles: stable x6.


Causes for Rejection

Gross hemolysis; gross lipemia


Test Details


Use

Therapeutic monitoring of etanercept and antidrug antibody development for individuals with Crohn's disease, inflammatory bowel disease, ulcerative colitis, rheumatoid arthritis, or other autoimmune conditions. This test provides etanercept drug concentration as well as the level of anti-etanercept antibodies.


Limitations

Failure of etanercept therapy may not always be due to the presence of anti-etanercept antibodies. Conversely, the absence of anti-etanercept antibodies does not guarantee response to treatment.


Methodology

Electrochemiluminescence immunoassay (ECLIA); enzyme-linked immunosorbent assay (ELISA)


Reference Interval

Etanercept drug level: Limit of quantitation: <0.2 μg/mL; a result of 0.2 μg/mL or higher indicates detection of etanercept. In the presence of anti-etanercept antibodies, the etanercept drug level reflects the antibody-unbound fraction of serum etanercept concentration.

Anti-etanercept antibody: Limit of quantitation: <75 ng/mL; a result of 75 ng/mL or higher indicates detection of anti-etanercept antibodies.


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
504245 ETA Conc+ETA Ab,Serial Monitor 504243 Etanercept Drug Concentration ug/mL 82470-6
504245 ETA Conc+ETA Ab,Serial Monitor 504244 Anti-Etanercept Antibody Level ng/mL 82469-8
Reflex Table for Anti-Etanercept Antibody Level
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 000000 Serial Monitoring 000000 Serial Monitoring N/A

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CPT Statement/Profile Statement

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