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Test ID FAAAB Adalimumab Concentration and Anti-Adalimumab Antibody

Method Name

Electrochemiluminescence immunoassay (ECLIA)

Reporting Name

Adalimumab and Anti-Adalimumab Ab

Specimen Type

Serum

Draw blood in a plain red-top tube(s), serum gel tube(s) is acceptable. Spin down and send 2 mL of serum frozen in a plastic vial.

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen (preferred) 7 days
  Ambient  7 days
  Refrigerated  7 days

Reference Values

Adalimumab Drug Level

            -Quantitation Limit: <0.6 ug/mL

            Results of 0.6 or higher indicates detection of adalimumab

 

In the presence of anti-adalimumab antibodies, they adalimumab drug level reflects the antibody-unbound fraction of adalimumab concentration in serum.

 

Anti-Adalimumab Antibody

            -Quantitation Limit: <25 ng/mL

            Results of 25 or higher indicates detection of anti-adalimumab antibodies.

 

All positive antibody results are verified by confirmatory test.

<100 ng/mL                   Low antibody titer, no significant impact on free drug level

101 – 300 ng/mL            Intermediate antibody titer, variable impact on free drug level

>301 ng/mL                   Hig antibody titer, significant impact on free drug level

 

Day(s) Performed

Monday, Wednesday

Report Available

3 - 7 days

Performing Laboratory

Esoterix Endocrinology

CPT Code Information

80299

82397

 

NY State Approved

Yes