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Test Code Adal w/Rflx Adalimumab Quantitative with Reflex to Antibody, Serum


Specimen Required


Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL


Seattle Children's Hospital Note:

Clinical System Name: Adalimumab Level with Reflex to Antibody

Useful For

Detection and quantification of antibodies directed against adalimumab in human serum

 

Trough level quantitation for evaluation of patients with loss of response to adalimumab

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
ADLAB Adalimumab Ab, S No No

Testing Algorithm

If the result is 5.0 mcg/mL or less, the adalimumab antibody test will be performed at an additional charge.

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Adalimumab QN with Reflex to Ab, S

Specimen Type

Serum

Specimen Minimum Volume

0.35 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 7 days
  Frozen  21 days
  Ambient  72 hours

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

NA

Reference Values

ADALIMUMAB QUANTITIATIVE WITH REFLEX TO ANTIBODY

Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific.

 

ADALIMUMAB ANTIBODY

<14.0 AU/mL

Method Description

The adalimumab enzyme-linked immunosorbent assay (ELISA) is designed to determine the quantity of free adalimumab (therapeutic antibody against tumor necrosis factor-alpha [TNF-alpha] ) in EDTA plasma or serum samples. In a first incubation step, the free adalimumab from the sample is bound to the specific monoclonal antiadalimumab antibody coated on the plate. To remove all unbound substances, a washing step is carried out. In a further incubation step, peroxidase-labeled antibody is added. Tetramethylbenzidine (TMB) is used as a substrate for peroxidase. Finally, an acidic stop solution is added to terminate the reaction. The color changes from blue to yellow. The intensity of the yellow color is directly proportional to the concentration of free adalimumab in the sample. A dose response curve of the absorbance unit (optical density, OD) verses concentration is generated, using the values obtained from standard. The concentrations of free adalimumab in the samples are determined directly from this curve.(Adalimumab Drug Level ELISA reagent package insert; ALPCO 30-ADLHU-E01, ver 2015-08-25

Day(s) and Time(s) Performed

Tuesday and Friday; 9 a.m.

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

80299-ADALX

83520-ADLAB (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ADALX Adalimumab QN with Reflex to Ab, S 74117-3

 

Result ID Test Result Name Result LOINC Value
ADALX Adalimumab QN with Reflex to Ab, S 74117-3