Test Details
Methodology
Electrochemiluminescence immunoassay (ECLIA)
Result 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.
Test Includes
This test includes serial monitoring.
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.
High serum biotin concentrations in patients taking biotin supplements may cause an interference in this assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.
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. |
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. High serum biotin concentrations in patients taking biotin supplements may cause an interference in this assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection. |
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 Instructions
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.
Reference Range
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.
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
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 | |
| Order Code | 504245 | |||||
| Order Code Name | Etanercept Drug + Antibody | |||||
| Order Loinc | ||||||
| Result Code | 504243 | |||||
| Result Code Name | Etanercept Drug Concentration | |||||
| UofM | ug/mL | |||||
| Result LOINC | 82470-6 | |||||
| Order Code | 504245 | |||||
| Order Code Name | Etanercept Drug + Antibody | |||||
| Order Loinc | ||||||
| Result Code | 504244 | |||||
| Result Code Name | Anti-Etanercept Antibody Level | |||||
| UofM | ng/mL | |||||
| Result LOINC | 82469-8 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 504107 | Serial Monitoring | 000000 | Serial Monitoring | N/A | |
| Reflex 1 | ||||||
| Order Code | 504107 | |||||
| Order Name | Serial Monitoring | |||||
| Result Code | 000000 | |||||
| Result Name | Serial Monitoring | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 504107 | Serial Monitoring | 511958 | 80563-0 | ||
| Reflex 1 | ||||||
| Order Code | 504107 | |||||
| Order Name | Serial Monitoring | |||||
| Result Code | 511958 | |||||
| Result Name | ||||||
| UofM | ||||||
| Result LOINC | 80563-0 | |||||