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Golimumab and Anti-Golimumab Antibody, DoseASSURE™ GOL

CPT: 80299; 82397
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Synonyms

  • DoseASSURE
  • Golimumab
  • Simponi

Expected Turnaround Time

5 - 12 days



Specimen Requirements


Specimen

Serum or plasma (EDTA)


Volume

3.0 mL


Minimum Volume

1.0 mL


Container

Serum-gel tube, red-top tube, or lavender top (EDTA) tube


Collection

Serum/plasma must be separated from cells within 45 minutes of venipuncture. Send serum/plasma in a plastic transport tube. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit seperate frozen specimens for each test requested.


Storage Instructions

Freeze


Stability Requirements

Temperature

Period

Room temperature

7 days

Refrigerated

7 days

Frozen

7 days

Freeze/thaw cycles

Stable x3


Causes for Rejection

Gross hemolysis, gross lipemia


Test Details


Limitations

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.


Methodology

Electrochemiluminescence Immunoassay


Reference Interval

Golimumab drug level: <0.5 μg/mL

• Result ≥0.5 μg/mL indicates 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: <20 ng/mL

• Result ≥20ng/mL indicates detection of anti-golimumab antibodies.


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
504563 Golimumab and Anti-Gol Ab 504564 Golimumab ug/mL 87406-5
504563 Golimumab and Anti-Gol Ab 504565 Anti-Golimumab Antibody ng/mL 87407-3

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