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Adalimumab and Anti-Adalimumab Antibody, DoseASSURE™ ADL
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80145; 82397 |
| 80145; 8239780145; 82397 |
Synonyms
- Anti-TNF-α Drug
- DoseASSURE
- Humira®
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Test Includes
Adalimumab concentration; antiadalimumab antibody level; serial monitoring
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Adalimumab concentration; antiadalimumab antibody level; serial monitoring Adalimumab concentration; antiadalimumab antibody level; serial monitoring |
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Adalimumab concentration; antiadalimumab antibody level; serial monitoring Adalimumab concentration; antiadalimumab antibody level; serial monitoring |
Expected 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.
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6 - 10 days 6 - 10 days |
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6 - 10 days 6 - 10 days |
Related Documents
For more information, please view the literature below.
Inflammatory Bowel Disease Biologics Flyer
Therapeutic Drug Monitoring Options for Rheumatoid Arthritis Flyer
Rheumatic Diseases Biologics (DoseASSURE™) Flyer
Biologic Therapeutic Drug Monitoring Q&A
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For more information, please view the literature below. Inflammatory Bowel Disease Biologics Flyer Therapeutic Drug Monitoring Options for Rheumatoid Arthritis Brochure |
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For more information, please view the literature below. Inflammatory Bowel Disease Biologics Flyer Therapeutic Drug Monitoring Options for Rheumatoid Arthritis Flyer Rheumatic Diseases Biologics (DoseASSURE™) Flyer Biologic Therapeutic Drug Monitoring Q&A |
Specimen Requirements
Specimen
Serum
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Serum Serum |
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Serum Serum |
Volume
2 mL
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2 mL 2 mL |
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2 mL 2 mL |
Minimum Volume
1 mL (Note: This volume does not allow for repeat testing.)
Container
Red-top tube or gel-barrier tube
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Red-top tube or gel-barrier tube Red-top tube or gel-barrier tube |
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Red-top tube or gel-barrier tube Red-top tube or gel-barrier tube |
Collection
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.
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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. 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. |
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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. 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. |
Storage Instructions
Refrigerate or freeze.
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Refrigerate or freeze. Refrigerate or freeze. |
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Refrigerate or freeze. Refrigerate or freeze. |
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 7 days |
Refrigerated | 7 days |
Frozen | 308 days |
Freeze/thaw Cycle | Stable x6 |
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Causes for Rejection
Plasma specimen received
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Plasma specimen received Plasma specimen received |
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Plasma specimen received Plasma specimen received |
Test Details
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.
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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. 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. |
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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. 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. |
Methodology
Electrochemiluminescence immunoassay (ECLIA)
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Electrochemiluminescence immunoassay (ECLIA) Electrochemiluminescence immunoassay (ECLIA) |
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Electrochemiluminescence immunoassay (ECLIA) Electrochemiluminescence immunoassay (ECLIA) |
Reference Interval
• 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.
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• 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. • 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. |
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• 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. • 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. |
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.
References
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Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to adalimumab: relationship to antiadalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007 Jul; 66(7):921-926. 17301106 Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology. 2009 Nov; 137(5):1628-1640. 19664627 Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to adalimumab: relationship to antiadalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007 Jul; 66(7):921-926. 17301106 Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology. 2009 Nov; 137(5):1628-1640. 19664627 |
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Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to adalimumab: relationship to antiadalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007 Jul; 66(7):921-926. 17301106 Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology. 2009 Nov; 137(5):1628-1640. 19664627 Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to adalimumab: relationship to antiadalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007 Jul; 66(7):921-926. 17301106 Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology. 2009 Nov; 137(5):1628-1640. 19664627 |
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 |
| Reflex Table for Anti-Adalimumab Antibody | ||||||
|---|---|---|---|---|---|---|
| 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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