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Overview
ข้อมูลทั่วไป Specimen
ข้อมูลสิ่งส่งตรวจ Performance
ข้อมูลการทดสอบ Clinical & Interpretation
ข้อมูลทางคลินิก

Test Code (รหัสการทดสอบ):

090-81-2021

Order Name (ชื่อการทดสอบ):

Vedolizumab Quantitation with Antibodies, Serum **

Specimen / Container (สิ่งส่งตรวจ/ภาชนะ):

Blood/ Plain blood (Red top) 6 mL, 2 tubes

Collection Instructions:
1. Draw blood immediately before next scheduled dose (trough specimen).
2. Centrifuge within 2 hours of draw.

Turnaround Time (ระยะเวลารอผล):

Received specimen to reported within 21 days

Useful For (ประโยชน์การทดสอบ):

Assessing the unexpected loss of response to therapy with vedolizumab over time
An aid to achieving desired serum levels of vedolizumab

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

Methodology (วิธีการทดสอบ):

Vedolizumab Quantitation: Liquid Chromatography- Mass Spectrometry (LC-MS/MS)
Vedolizumab Ab: Electrochemiluminescent Bridging Immunoassay

Test List In Profile (การทดสอบใน Profile):

Vedolizumab QN
Vedolizumab Ab

AliasesName (ชื่อเรียกอื่นๆ) :

Entyvio (Vedolizumab) Level
ID: VEDOZ

Test Code (รหัสการทดสอบ):

090-81-2021

Order Name (ชื่อการทดสอบ):

Vedolizumab Quantitation with Antibodies, Serum **

Patient Preparation (การเตรียมตัวผู้ป่วย):

1. 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.

Collection Specimen Or Container (สิ่งส่งตรวจ/ภาชนะ):

Blood/ Plain blood (Red top) 6 mL, 2 tubes

Collection Instructions:
1. Draw blood immediately before next scheduled dose (trough specimen).
2. Centrifuge within 2 hours of draw.

Specimen Testing Type (สิ่งส่งตรวจที่ใช้ในการทดสอบ):

Serum, minimum volume 1.5 mL x 4 tubes

Sub Mission Container (ภาชนะส่งตรวจ):

Plastic tube

Rejection Criteria (เกณฑ์ปฏิเสธสิ่งส่งตรวจ):

Gross hemolysis	OK
Gross lipemia	OK
Gross icterus	OK

Specimen Stabillity (ความคงตัวของสิ่งส่งตรวจ):

Specimen Type	Temperature	Time
Serum	Frozen (preferred)	28 days
Serum	Refrigerated, 2^oC to 8^oC	28 days

Test Code (รหัสการทดสอบ):

090-81-2021

Order Name (ชื่อการทดสอบ):

Vedolizumab Quantitation with Antibodies, Serum **

Method detail (วิธีการทดสอบ):

Vedolizumab Quantitation: Liquid Chromatography- Mass Spectrometry (LC-MS/MS)
Vedolizumab Ab: Electrochemiluminescent Bridging Immunoassay

Schedule (ตารางการทดสอบ):

N/A **Sent out to MAYO, USA

Turnaround Time (ระยะเวลารอผล):

Received specimen to reported within 21 days

Performing Location (หน่วยงานที่ทำการทดสอบ):

MAYO Laboratory
Referral Lab Services, Laboratory Department 14160-2

Test Code (รหัสการทดสอบ):

090-81-2021

Order Name (ชื่อการทดสอบ):

Vedolizumab Quantitation with Antibodies, Serum **

Clinical Information (ข้อมูลทางคลินิก):

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 Value (ค่าอ้างอิง):

VEDOLIZUMAB QUANTITATION :
Vedolizumab lower limit of quantitation: 2.0 mcg/mL

VEDOLIZUMAB ANTIBODIES :
Antibodies to vedolizumab: <9.8 ng/mL

Interpretation (การแปลผล):

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:
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 (เอกสารอ้างอิง):