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Golimumab and Anti-Golimumab Antibody, DoseASSURE™ GOL

CPT: 80299; 82397
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Synonyms

  • DoseASSURE
  • Golimumab
  • Simponi

Test Includes

This test includes serial monitoring.


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 Drug + Antibody 504564 Golimumab ug/mL 87406-5
504563 Golimumab Drug + Antibody 504565 Anti-Golimumab Antibody ng/mL 87407-3
Reflex Table for Anti-Golimumab 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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