Test Details
Methodology
Electrochemiluminescence immunoassay (ECLIA)
Result Turnaround Time
6 - 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
Adalimumab concentration; antiadalimumab antibody level; serial monitoring
Use
Monitor antiadalimumab therapy for individuals with Crohn's disease, inflammatory bowel disease, ulcerative colitis, rheumatoid arthritis, or other autoimmune conditions. This test provides adalimumab drug concentration levels as well as the level of antiadalimumab antibodies.
References
Custom Additional Information
In the absence of antiadalimumab antibodies, the adalimumab drug level typically reflects the total adalimumab concentration in serum. In the presence of antiadalimumab antibodies, the adalimumab level typically reflects the antibody-unbound fraction of adalimumab concentration in serum.
This assay provides clinically valid antibody results at drug levels well above treatment targets (>30 μg/mL). Failure of adalimumab therapy may not always be due to the presence of antiadalimumab antibodies. In addition, the absence of antiadalimumab antibodies does not guarantee positive response to treatment.
Specimen Requirements
Specimen
Serum
Volume
2 mL
Minimum Volume
1 mL (Note: This volume does not allow for repeat testing.)
Container
Red-top tube or gel-barrier tube
Collection Instructions
Allow a minimum clotting time of 30 to 60 minutes with serum separation within 2 hours of collection. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 7 days |
Refrigerated | 7 days |
Frozen | 308 days |
Freeze/thaw Cycle | Stable x6 |
Reference Range
• Adalimumab drug level:
− Quantitation limit: <0.6 μg/mL
− Results ≥0.6 μg/mL indicate detection of adalimumab.
In the presence of antiadalimumab antibody, the adalimumab drug level reflects the antibody-unbound fraction of adalimumab concentration in serum.
• Antiadalimumab antibody:
− Quantitation limit: <25 ng/mL
− Results ≥25 ng/mL indicate detection of adalimumab antibody.
Storage Instructions
Refrigerate or freeze.
Causes for Rejection
Plasma specimen received
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 503890 | Adalimumab Drug + Antibody | 99781-7 | 503866 | Adalimumab Drug Level | ug/mL | 74117-3 |
| 503890 | Adalimumab Drug + Antibody | 99781-7 | 503867 | Anti-Adalimumab Antibody | ng/mL | 74116-5 |
| Order Code | 503890 | |||||
| Order Code Name | Adalimumab Drug + Antibody | |||||
| Order Loinc | 99781-7 | |||||
| Result Code | 503866 | |||||
| Result Code Name | Adalimumab Drug Level | |||||
| UofM | ug/mL | |||||
| Result LOINC | 74117-3 | |||||
| Order Code | 503890 | |||||
| Order Code Name | Adalimumab Drug + Antibody | |||||
| Order Loinc | 99781-7 | |||||
| Result Code | 503867 | |||||
| Result Code Name | Anti-Adalimumab Antibody | |||||
| UofM | ng/mL | |||||
| Result LOINC | 74116-5 |
| 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 | |||||