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Test Code FGAGA Golimumab and Anti-Golimumab Antibody, DoseASSURE GOL


Specimen Required


Specimen Type: Serum

Container/Tube: SST or Red

Specimen Volume: 3 mL

Collection Instructions: Draw blood in a serum gel tube(s), plain red-top tube(s) is acceptable. Serum must be separated from cells within 45 minutes of venipuncture. Spin down and send 3 mL of serum frozen in a plastic vial.

To avoid delays in turnaround time when requesting multiple tests, please submit separate frozen specimens for each test requested.


Method Name

Electrochemiluminescence immunoassay (ECLIA)

Reporting Name

Golimumab and Anti-Gol Ab

Specimen Type

Serum

Specimen Minimum Volume

1 mL (Note: This volume does not allow for repeat testing.)

Specimen Stability Information

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

Reject Due To

Gross hemolysis Gross reject; Mild OK
Gross lipemia Reject
Gross icterus NA
Other/Tissue/Swab Specimens other than indicated

Reference Values

Golimumab:

Quantitation Limit: <0.5 ug/mL

 

Results of 0.5 ug/mL or higher indicate detection of Golimumab

In the presence of serum anti-golimumab antibodies, the golimumab drug level reflects the antibody-unbound (free) fraction of golimumab in serum

 

Anti-Golimumab Antibody:

Quantitation Limit: <20 ng/mL

 

Results of 20 or higher indicate detection of anti-Golimumab antibodies.

Cautions

Failure of golimumab therapy may not always be due to the presence of anti-golimumab antibodies. Conversely, the absence of anti-golimumab antibodies does not guarantee response to treatment.

Performing Laboratory

Esoterix Endocrinology

Test Classification

These tests were developed and their performance characteristics determined by LabCorp. They have not been cleared or approved by the Food and Drug Administration.

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FGAGA Golimumab and Anti-Gol Ab Not Provided

 

Result ID Test Result Name Result LOINC Value
Z5639 Golimumab 87406-5
Z5640 Anti-Golimumab Antibody 87407-3

CPT Code Information

80299

82397

Day(s) Performed

Tuesday

Report Available

7 to 18 days