Adalimumab Activity and Neutralizing Antibody
| Label Mnemonic: | ADANAB |
| Epic code: | LAB8152 |
| Downtime form: | A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery |
Commercial Mailout Laboratory
6240-8 RCP
356-8593
6240-8 RCP
356-8593
Specimen(s):
Serum
Specimen
Instructions:
Patient Preparation: Collect specimens before adalimumab treatment.
Collection Medium:
 |
| Red top tube 5 mL (Clot Activator) |
Minimum:
Preferred Minimum: 1 mL serum
Absolute Minimum: 0.3 mL serum
Absolute Minimum: 0.3 mL serum
Rejection Criteria:
Contaminated, hemolyzed, icteric, or lipemic specimens.
Turn Around
Time:
2-3 days upon receipt at reference laboratory
Reference Range:
Adalimumab Activity - Not Detected
Adalimumab Neutralizing Antibody - Not Detected
Adalimumab Neutralizing Antibody - Not Detected
Interpretive Data:
This test measures the capacity of adalimumab to neutralize TNF-
activity. Additionally, adalimumab neutralizing antibodies (NAb) are
titered (reporting the highest dilution of patient sera in which NAb
activity is detected).
This test is used to evaluate secondary response failures to adalimumab therapy. Secondary response failure is defined as loss of clinical response after initial improvement of clinical signs and symptoms. Therapeutic decision should rest on both the clinical response and the knowledge of the fate of the drug including the emergence of immunogenicity in individual patients.
Circulating adalimumab levels have been shown to vary considerably between patients. These differences relate to route and frequency of administration and patient-related features such as age, gender, weight, drug metabolism, and concomitant medications such as methotrexate and other immunosuppressants.
The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
This test is used to evaluate secondary response failures to adalimumab therapy. Secondary response failure is defined as loss of clinical response after initial improvement of clinical signs and symptoms. Therapeutic decision should rest on both the clinical response and the knowledge of the fate of the drug including the emergence of immunogenicity in individual patients.
Circulating adalimumab levels have been shown to vary considerably between patients. These differences relate to route and frequency of administration and patient-related features such as age, gender, weight, drug metabolism, and concomitant medications such as methotrexate and other immunosuppressants.
The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
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IF Adalimumab AND Adalimumab Neutralizing THEN
Activity is Ab. Titer is
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Not Detected Not Detected A higher dosage of
adalimumab or shortening
the dosing interval may be
appropriate.
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Not Detected 1:20 or greater A change to another anti-
drug may be appropriate.
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0.65 ug/mL Not Detected A change to another type
or greater of therapy (not targeting
TNF-may be appropriate.
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0.65 ug/mL 1:20 or greater Repeat testing is
or greater suggestedto rule out
decreasing adalimumab
activity and/or
increasing adalimumab
neutralizing antibodies.
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Comments:
This tests is used to evaluate response failure to adalimumab therapy.
Determine and adjust dosage or identify the need for change to another
anti-TNF-α inhibitor.
Methodology:
ll Culture/Quantitative Chemiluminescent Immunoassay/ Semi-Quantitative
Chemiluminescent Immunoassay
CPT Code:
80145 - Adalimumab Activity
82397 - Adalimumab Neutralizing Antibody
82397 - Adalimumab Neutralizing Antibody