Test Catalog

Test Id : VEDOL

Vedolizumab Quantitation with Reflex to Antibodies, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Assessing the response to therapy with vedolizumab

 

An aid to achieving desired trough serum levels of vedolizumab

 

Monitoring patient compliance

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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 quantitation and, if appropriate, antibody testing will be performed. The therapeutic thresholds for vedolizumab and optimal concentrations associated with good outcomes are not well established. The American Gastroenterology Association (AGA) does not have a formal guideline on optimal thresholds for vedolizumab at this time.

 

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

Method Name
A short description of the method used to perform the test

VEDOL: Liquid Chromatography- Mass Spectrometry (LC-MS/MS)

VEMAB: Electrochemiluminescent Bridging Immunoassay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Vedolizumab QN, S

Aliases
Lists additional common names for a test, as an aid in searching

Vedolizumab

VEDO

Entyvio

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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 quantitation and, if appropriate, antibody testing will be performed. The therapeutic thresholds for vedolizumab and optimal concentrations associated with good outcomes are not well established. The American Gastroenterology Association (AGA) does not have a formal guideline on optimal thresholds for vedolizumab at this time.

 

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

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

This test includes quantitation and, if appropriate, antibody testing will be performed. Therapeutic thresholds for vedolizumab optimal concentrations associated with good outcomes are not well established. The American Gastroenterology Association (AGA) does not have a formal guideline on optimal thresholds for vedolizumab at this time.

 

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

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

1. Patient Preparation: For 12 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

2. Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to testing for vedolizumab quantitation in serum.

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1.5 mL

Collection Instructions:

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

2. Centrifuge within 2 hours of draw.

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.75 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia Reject
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

Assessing the response to therapy with vedolizumab

 

An aid to achieving desired trough serum levels of vedolizumab

 

Monitoring patient compliance

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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 quantitation and, if appropriate, antibody testing will be performed. The therapeutic thresholds for vedolizumab and optimal concentrations associated with good outcomes are not well established. The American Gastroenterology Association (AGA) does not have a formal guideline on optimal thresholds for vedolizumab at this time.

 

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Vedolizumab (Entyvio) is a humanized monoclonal antibody directed against integrin alpha-4 beta-7. Blocking the alpha-4 beta-7 integrin results in a gut-selective anti-inflammatory response. The drug is FDA-approved for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn disease. Although optimal therapeutic concentrations of vedolizumab are not well known, Mayo Clinic Gastroenterologists are working to correlate drug concentrations with patient outcomes. Vedolizumab testing will assess the patients loss of response to therapy, similar to therapy received using tumor necrosis factor (TNF) inhibitors, such as infliximab and adalimumab. Some patients on vedolizumab may develop antibodies to vedolizumab (ATV) over time. In clinical trials, approximately 4% of patients treated with vedolizumab were positive for ATV at any time and 1% or less were persistently positive. Therefore, simultaneous testing for measurement of ATV is recommended. ATV uses a bridging immunoassay on an electrochemiluminescence (Mesoscale Discovery) platform.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

VEDOLIZUMAB QUANTITATION :

Vedolizumab lower limit of quantitation: 2.0 mcg/mL

 

VEDOLIZUMAB ANTIBODIES :

Antibodies to vedolizumab: <9.8 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

Data in the literature with association of vedolizumab trough levels and improved outcomes is still scarce. The limit of quantitation of the test is 2.0 mcg/mL. In a retrospective Mayo Clinic study conducted from 2016-2017 with 171 patients (62% Crohn disease, 31% ulcerative colitis, and 7% indeterminate colitis), the median vedolizumab trough concentration was 15.3 mcg/mL. Minimum trough (immediately before next infusion) therapeutic concentrations of vedolizumab are expected to be above 15 mcg/mL.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Patients actively undergoing therapy with both vedolizumab and nivolumab (extremely rare scenario) should not have their therapeutic vedolizumab concentration assessed using this test. If the patient has taken nivolumab in the past, they should wait for 4 weeks after therapy with nivolumab has ended before being tested for vedolizumab quantitation using this method.

 

The presence of high concentrations of vedolizumab might inhibit the antibodies to vedolizumab (ATV) assay yielding false-negative results. In patients with concentrations of vedolizumab greater than 15.0 mcg/mL, the presence of an ATV is of little clinical significance.

 

Samples containing more than 100 ng/mL biotin (vitamin B7) may interfere (in the form of depressed signal) with VEMAB / Vedolizumab Antibodies, Serum.

 

Clinical management decisions for patients receiving vedolizumab treatment should not be based solely on quantitation of vedolizumab and assessment of ATV if appropriate. Test results must be interpreted within the clinical context of the patient.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Willrich MA, Murray DL, Barnidge DR, et al: Quantitation of infliximab using clonotypic peptides and selective reaction monitoring by LC-MS/MS. International immunopharmacology 2015 Sep;28(1):513-520

2. Katrangi W, Ladwig PM, Barnidge DR, et al: A-260 Vedolizumab Quantitation in Serum using SRM and micro LC-ESI-Q-TOF Mass Spectrometry. Clin Chem 2015;61

3. Ladwig PM, Barnidge DR, Willrich MA: Mass Spectrometry Approaches for Identification and Quantitation of Therapeutic Monoclonal Antibodies in the Clinical Laboratory. Clin Vaccine Immunol 2017 May 5;24(5)

4. Ladwig PM, Barnidge DR, Willrich MA: Quantification of the IgG2/4 kappa Monoclonal Therapeutic Eculizumab from Serum Using Isotype Specific Affinity Purification and Microflow LC-ESI-Q-TOF Mass Spectrometry. J Am Soc Mass Spectrom 2017 May;28(5):811-817

5. Feagan BG, Rutgeerts P, Sands BE, et al: Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med 2013;Aug 22;369(8):699-710

6. Schulze H, Esters P, Hartmann F, et al: A prospective cohort study to assess the relevance of vedolizumab drug level monitoring in IBD patients. Scand J Gastroenterol. 2018:1-7

7. Al-Bawardy B, Piovezani Ramos G, Willrich MAV, et al: P167 Vedolizumab Trough Levels and Antibodies in Inflammatory Bowel Disease: Updated Initial Experience. Gastroenterology154:S89

Method Description
Describes how the test is performed and provides a method-specific reference

Vedolizumab Quantitation:

Vedolizumab is extracted from serum and measured by liquid chromatography (high-resolution accurate-mass, HRAM) mass spectrometry.(Unpublished Mayo method)

 

Vedolizumab Antibodies:

Testing for antibodies to vedolizumab is accomplished using a laboratory-developed immunoassay.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

VEDOL: Monday, Thursday

VEMAB: Tuesday, Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

7 to 14 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80280

82397 (if appropriate)

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports