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Golimumab and Anti-Golimumab Antibody, DoseASSURE™ GOL

CPT

80299; 82397

Synonyms
  • DoseASSURE
  • Golimumab
  • Simponi
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  • Updated on 04/03/2025

Test Details

Methodology

Electrochemiluminescence Immunoassay

Result Turnaround Time

5 - 12 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Test Includes

This test includes serial monitoring.

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.

High serum biotin concentrations in patients taking biotin supplements may cause an interference in this assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.

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.

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.

High serum biotin concentrations in patients taking biotin supplements may cause an interference in this assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.

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 Instructions

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.

Stability Requirements

TemperaturePeriod
Room temperature7 days
Refrigerated7 days
Frozen7 days
Freeze/thaw cyclesStable x3

Reference Range

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.

Storage Instructions

Freeze.

Causes for Rejection

Gross hemolysis, gross lipemia

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
Order Code504563
Order Code NameGolimumab Drug + Antibody
Order Loinc
Result Code504564
Result Code NameGolimumab
UofMug/mL
Result LOINC87406-5
Order Code504563
Order Code NameGolimumab Drug + Antibody
Order Loinc
Result Code504565
Result Code NameAnti-Golimumab Antibody
UofMng/mL
Result LOINC87407-3
Reflex Table for Anti-Golimumab Antibody
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 504108 Serial Monitoring 000000 Serial Monitoring N/A
Reflex 1
Order Code504108
Order NameSerial Monitoring
Result Code000000
Result NameSerial Monitoring
UofM
Result LOINCN/A
Reflex Table for Anti-Golimumab Antibody
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 504108 Serial Monitoring 511958 PDF 80563-0
Reflex 1
Order Code504108
Order NameSerial Monitoring
Result Code511958
Result NamePDF
UofM
Result LOINC80563-0