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Test ID GUSAP Guselkumab Quantitation with Antibodies, Serum

Method Name

GUS: Liquid Chromatography Mass Spectrometry (LC-MS)

GUSAB: Electrochemiluminescent Bridging Immunoassay (ECLIA)


Specimen Required


Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1.1 mL serum

Collection Instructions:

1. Draw blood immediately before next scheduled dose (trough specimen).

2. Within 2 hours of collection, centrifuge, and aliquot serum into a plastic vial.


Reporting Name

Guselkumab QN with Antibodies, S

Specimen Type

Serum

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 28 days
  Frozen  28 days
  Ambient  24 hours

Report Available

2 to 9 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

LOINC Code Information

Test ID Test Order Name Order LOINC Value
GUSAP Guselkumab QN with Antibodies, S In Process

 

Result ID Test Result Name Result LOINC Value
622837 Guselkumab, S 112387-6
623122 Guselkumab Ab, S In Process
623291 GUSAB Interpretation 77202-0

Forms

If not ordering electronically, complete, print, and send Gastroenterology and Hepatology Test Request (T728) with the specimen.

Useful For

Evaluation of patients with limited primary (initial) response to or secondary loss of response to guselkumab.

Day(s) Performed

Weekly

Test Classification

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.

CPT Code Information

80299

83520

Profile Information

Test ID Reporting Name Available Separately Always Performed
GUS Guselkumab, S Yes Yes
GUSAB Guselkumab Ab, S No Yes

Specimen Minimum Volume

Serum: 0.75 mL

Reference Values

GUSELKUMAB QUANTITATION:

Guselkumab lower limit of quantitation = 0.5 mcg/mL

 

ANTIBODIES TO GUSELKUMAB:

<9.8 ng/mL