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Adalimumab and Anti-Adalimumab Antibody (Serial Monitor), DoseASSURE™ ADL

CPT: 80145; 82397
80299; 82397
80145; 82397
Updated on 01/17/2020
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Synonyms

  • Anti-TNF-α Drug
  • DoseASSURE
  • Humira®

Test Includes

Adalimumab concentration; antiadalimumab antibody level; serial monitoring

Adalimumab concentration; antiadalimumab antibody level; serial monitoring


Expected Turnaround Time

6 - 10 days



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

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.


Stability Requirements

Temperature

Period

Room temperature

7 days

Refrigerated

7 days

Frozen

308 days

Freeze/thaw Cycle

Stable x6


Causes for Rejection

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.


Methodology

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.


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

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+Ab (Serial Monitor) 503866 Adalimumab Drug Level ug/mL 74117-3
503890 Adalimumab+Ab (Serial Monitor) 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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