Etanercept and Anti-Etanercept Antibody, DoseASSURE™ ETN

TEST: 504245
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CPT: 80299; 82397
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Synonyms

  • Anti-TNF
  • DoseASSURE
  • Enbrel®

Test Includes

This test includes serial monitoring.

Expected Turnaround Time

6 - 12 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.

Related Documents

For more information, please view the literature below.

Therapeutic Drug Monitoring Options for Rheumatoid Arthritis Flyer

Rheumatic Diseases Biologics (DoseASSURE™) Flyer

Biologic Therapeutic Drug Monitoring Q&A

Rheumatoid Arthritis (RA) Comprehensive Testing Brochure

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)

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 Etanercept Drug + Antibody 504243 Etanercept Drug Concentration ug/mL 82470-6
504245 Etanercept Drug + Antibody 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 504107 Serial Monitoring 000000 Serial Monitoring N/A
Reflex Table for Anti-Etanercept Antibody Level
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 504107 Serial Monitoring 511958 PDF 80563-0

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