Specimen Requirements

Minimum Specimen Requirements

Stability

Days Performed

Mon, Wed, Thu, Sat

Turnaround Time

3 - 4 days

Methodology

Special Info

Patient Prep: Collect specimens before adalimumab treatment. Hemolyzed, icteric, lipemic or contaminated specimens are unacceptable. This test is New York DOH approved.

Clinical Info

This test measures the capacity of adalimumab to neutralize TNF-alpha activity. Additionally, adalimumab neutralizing antibodies (NAb) are titered (reporting the minimal serum dilution at which blocking of adalimumab activity is no longer observed). Testing 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 weight, gender, age, drug metabolism, and concomitant medications such as methotrexate and other immunosuppressants. If adalimumab activity is not detected AND adalimumab neutralizing Ab titer is not detected, then a higher dosage of adalimumab or shortening the dosing interval may be appropriate. If adalimumab activity is not detected AND adalimumab neutralizing Ab titer is 1:20 or greater, then a change to another anti-TNF- drug may be appropriate. If adalimumab activity is 0.65 ug/mL or greater AND adalimumab neutralizing Ab titer is not detected, then a change to another type of therapy (not targeting TNF-) may be appropriate. If adalimumab activity is 0.65 ug/mL or greater AND adalimumab neutralizing Ab titer is 1:20 or greater, then repeat testing is suggested to rule out decreasing adalimumab activity and/or increasing adalimumab neutralizing antibodies.