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Test Code VEDOZ Vedolizumab Quantitation with Antibodies, Serum


Ordering Guidance


If there is a known justification for performing both quantitation and antibody levels, this is the correct test to order. If there is not a known reason to perform the antibodies component, consider VEDOL / Vedolizumab Quantitation with Reflex to Antibodies, Serum. VEDOL testing begins with vedolizumab quantitation. When the quantitation results are 15.0 mcg/mL or less, testing for antibodies to vedolizumab will be performed.



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

Profile Information

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

Testing Algorithm

When this test is ordered, vedolizumab quantitation and testing for antibodies to vedolizumab will always be performed.

 

This test includes both quantitation and antibody testing on all specimens. The therapeutic thresholds for vedolizumab and optimal concentrations associated with good outcomes are not well established. 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 with Antibodies, 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

Vedolizumab quantitation: Monday, Wednesday, Thursday

Vedolizumab antibodies: Tuesday, Friday

Report Available

5 to 8 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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
VEDOZ Vedolizumab QN with Antibodies, S 90794-9

 

Result ID Test Result Name Result LOINC Value
602807 Vedolizumab QN, S 90805-3
603298 Vedolizumab Ab, S 86899-2
603299 VEMAB Interpretation 59462-2

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)