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Test Code USTEK Ustekinumab Quantitation with Antibodies, Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL Serum

Collection Instructions:

1. Draw blood immediately before the next dose of drug administration (trough level).

2. Centrifuge and aliquot serum into a plastic vial.


Children's Mercy Hospital Note:

CMH COLLECTION: 2 mL in red gel vacutainer

Specimen Minimum Volume

Serum: 0.35 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Useful For

Evaluating patients for loss of response, partial response on initiation of therapy, autoimmune or hypersensitivity reactions, primary nonresponse, reintroduction after drug holiday, endoscopic/computed tomography enterography recurrence (in inflammatory bowel disease) and acute infusion reactions using trough level specimens

 

This test does not differentiate between the originator and biosimilar products.

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK
Heat-inactivated specimen Reject

Day(s) Performed

Monday, Wednesday, Friday

Report Available

2 to 5 days

Reporting Name

Ustekinumab QN with Antibodies, S

Reference Values

USTEKINUMAB QUANTITATION:

Limit of quantitation is 0.3 mcg/mL

 

For maintenance stages:

Concentrations ≥1.0 mcg/mL are associated with clinical response and clinical remission

Concentrations ≥4.5 mcg/mL are associated with mucosal healing

 

USTEKINUMAB ANTIBODIES:

Limit of quantitation is 10 AU/mL

Absent: <10 AU/mL

Present: ≥10 AU/mL

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

80299

83520

Profile Information

Test ID Reporting Name Available Separately Always Performed
USQN Ustekinumab QN, S No Yes
USTAB Ustekinumab Ab, S No Yes