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Test Directory Ustekinumab Quantitation with Antibodies, Serum

Ustekinumab Quantitation with Antibodies, Serum

Test Summary

Evaluation of loss of response to therapy, Quantification of ustekinumab in human serum, Trough level quantitation for evaluation of patients treated with ustekinumab, Detection of antibodies to ustekinumab in human serum

Aliases

Stelara, Stelara antibodies

Specimen Collection

Special Instructions

N/A

Preferred Specimen

0.5 mL serum from a serum separator tube

Minimum Volume

0.35 mL

Instructions

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

Patient Preparation

Collect immediately before the next dose of drug administration (trough level)

Storage

Plastic screw-cap vial

Transport Temperature

Refrigerated

Specimen Stability

Room Temperature: N/a
Refrigerated: 21 days
Frozen: 21 days

Limitations

N/A

Other Acceptable Specimens

Serum from a red top tube

Unacceptable Specimens

Heat-activated specimen

Order Code

USTEK

EPIC (Premier) Code

LAB6766

Includes

N/A

CPT Code

80299
83520

Billing Code

650059
650060

CPT Statement

Methodology

Enzyme Linked Immunosorbent Immunoassay (ELISA)

FDA Status

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Mayo Clinic Laboratories -- Rochester Superior Drive
3050 Superior Drive NW
Rochester MN, 55901

Department

Reference Testing

Reference Range

N/A

Setup Schedule / Expected Turnaround Time

Monday, Wednesday, Friday; Report available: 2 - 5 days