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Test Code VEDOL Vedolizumab Quantitation with Reflex to Antibodies, Serum

Additional Codes

Mayo Code
VEDOL
EPIC Code
LAB3457
Sunqust Code
VEDOL

 


Ordering Guidance


If both quantitation and antibody testing are needed, regardless of the quantitation results, order VEDOZ / Vedolizumab Quantitation with Antibodies, Serum.



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)

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 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.


Useful For

Evaluation of patients with loss of response to vedolizumab (VDZ) with recurrence of symptoms and/or low or undetectable serum VDZ measured at trough

 

Monitoring vedolizumab concentrations in patients undergoing therapy with this biologic for ulcerative colitis or Crohn disease

 

Assessing the loss of response to VDZ therapy

 

As an aid to achieving desired serum concentration of VDZ

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
VEMAB Vedolizumab Ab, S No No

Testing Algorithm

Vedolizumab quantitation will be performed by liquid chromatography mass spectrometry on all samples. When this test is ordered and vedolizumab results are 15.0 mcg/mL or less, then testing for antibodies to vedolizumab will be performed at an additional charge.

 

This test includes vedolizumab drug quantitation and, if appropriate, antibody testing for antibodies-to-vedolizumab will be performed. Currently, the American Gastroenterology Association does not have a formal guideline on optimal thresholds for vedolizumab trough concentrations in the setting of loss of response to therapy, but trough concentrations greater than 15 mcg/mL have been associated with clinical or endoscopic remission and mucosal healing in inflammatory bowel disease.

 

For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.

Reporting Name

Vedolizumab QN, S

Specimen Type

Serum

Specimen Minimum Volume

Serum: 0.3 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Reference Values

VEDOLIZUMAB QUANTITATION:

Vedolizumab lower limit of quantitation: 1.0 mcg/mL

 

VEDOLIZUMAB ANTIBODIES:

Antibodies to vedolizumab: <9.8 ng/mL

 

Absence of antibodies to vedolizumab is defined as <9.8 ng/mL

Presence of ATV is reported as positive when concentrations are ≥9.8 ng/mL

Day(s) Performed

Monday, Wednesday, Thursday

Report Available

5 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

80280

82397 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
VEDOL Vedolizumab QN, S 90805-3

 

Result ID Test Result Name Result LOINC Value
602807 Vedolizumab QN, S 90805-3

Forms

If not ordering electronically, complete, print, and send 1 of the following with the specimen:

-Gastroenterology and Hepatology Test Request (T728)

-Therapeutics Test Request (T831)