Etanercept and Anti-Etanercept Antibody, DoseASSURE™ ETN
CPT:
80299; 82397
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
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 | 80563-0 | ||
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