Test Catalog

Test Id : USTEK

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Ustekinumab Quantitation with Antibodies, Serum

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Overview

Test Catalog

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

Evaluation of loss of response to therapy

 

Quantification of ustekinumab in human serum

 

Trough level quantitation for evaluation of patients treated with ustekinumab

 

Detection of antibodies to ustekinumab in human serum

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
USQN Ustekinumab QN, S No Yes
USTAB Ustekinumab Ab, S No Yes

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

Enzyme-Linked Immunosorbent Assay (ELISA)

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

Ustekinumab QN with Antibodies, S

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

Stelara

Stelara antibodies

Specimen Type
Describes the specimen type validated for testing

Serum

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

Patient Preparation: Collect immediately before the next dose of drug administration (trough level)

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

Forms

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

-Gastroenterology and Hepatology Client Test Request (T728)

-Therapeutics Test Request (T831)

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

0.35 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Heat-inactivated specimen Reject

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) 21 days
Frozen 21 days

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

Evaluation of loss of response to therapy

 

Quantification of ustekinumab in human serum

 

Trough level quantitation for evaluation of patients treated with ustekinumab

 

Detection of antibodies to ustekinumab in human serum

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

Ustekinumab (UTK) is a fully human IgG1 kappa monoclonal antibody (1) that binds with high affinity to the p40 subunit of human interleukin (IL)12 and IL23 and has been approved for the treatment of patients with moderate to severe Crohn disease (CD), moderate to severe ulcerative colitis (UC), psoriatic arthritis, and plaque psoriasis. The drug prevents IL12 and IL23 bioactivity by binding and neutralizing the shared p40 subunit, preventing interaction with the cell surface receptor protein IL12Rbeta1. Through this mechanism of action, UTK effectively neutralizes IL12 and IL23, proteins that are thought to be associated with gastrointestinal inflammation in CD and UC. In the setting of the inflammatory bowel diseases (IBD), CD and UC, the treatment regimen is started with a single weight-based loading dose of the t-mab administered intravenously (IV), and a maintenance regimen with standard (non-weight based) subcutaneous administration of ustekinumab 8 weeks after induction dose, and every 8 weeks thereafter. There is very little data supporting proactive therapeutic drug monitoring for ustekinumab.

 

The test is most useful in the evaluation of loss of response to therapy. A gradual decrease in efficacy over time following an initial response to biologics is common. In many cases, antibodies generated to the biologic are responsible for treatment failure, as they bind to the drug creating an immunocomplex and clearing the drug faster from circulation.

 

For IBD, measurements in nonresponders are indicated at post-induction (week 8) and concentrations of ustekinumab associated with favorable outcomes are greater than 3.5 mcg/mL. In addition, for measurements during maintenance stages of therapy, ustekinumab concentrations > or =1 mcg/mL are associated with clinical response and clinical remission. At maintenance stages, ustekinumab concentrations > or =4.5 mcg/mL are associated with mucosal healing.

 

In clinical trials, 6% to 12.4% of patients using ustekinumab for psoriasis or psoriatic arthritis developed antibodies-to-ustekinumab (ATU) over time. For IBD, between 2.9% and 4.6% of patients developed ATU when treated with ustekinumab for one year.(1) Therefore, it is important to monitor trough concentrations of serum UTK to correlate drug levels with loss of response to therapy. ATU may increase drug clearance in treated patients or neutralize the drug effect, thereby potentially contributing to the loss of response. ATU could also cause adverse events such as serum sickness and hypersensitivity reactions.

 

Currently, ustekinumab quantitation is performed in conjunction with immunogenicity assessment for ATU.

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.

USTEKINUMAB QN, S:

Limit of quantitation is 0.3 mcg/mL

 

In inflammatory bowel disease, at post-induction measurement (week 8), concentrations above 3.5 mcg/mL are associated with good outcomes

 

For maintenance stages:

Concentrations > or =1.0 mcg/mL are associated with clinical response and clinical remission

Concentrations > or =4.5 mcg/mL are associated with mucosal healing

 

USTEKINUMAB AB, S:

Limit of quantitation is 10 AU/mL

Absent: <10 AU/mL

Present: > or =10 AU/mL

Interpretation
Provides information to assist in interpretation of the test results

Antibodies to ustekinumab (ATU) absent

ATU present

Ustekinumab quantification

<1.0 mcg/mL

For nonresponders:

Insufficient ustekinumab is present.

In the absence of ATU, consider optimizing therapy by increasing the dose or shortening the administration intervals, or by adding an immunomodulator to the therapeutic regimen.

For nonresponders:

Insufficient ustekinumab is present. Antibodies-to-ustekinumab detected can contribute to faster clearance of ustekinumab and treatment failure. Clinical evaluation is recommended.

Ustekinumab quantification

> or =1.0 mcg/mL

For nonresponders:

If the sample was collected at trough ie, immediately before the next infusion, the results could suggest a mechanistic failure of ustekinumab. The provider may consider switching therapeutic regimen outside of the drug class.

For nonresponders:

If the sample was collected at trough ie, immediately before the next infusion, the results could suggest a mechanistic failure of ustekinumab. The provider may consider switching therapeutic regimen outside of the drug class.

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

This assay measures free ustekinumab. This assay does not measure ustekinumab bound to anti-ustekinumab antibodies (immunocomplexes).

 

Presence of ustekinumab at concentrations greater than 1 mcg/mL may impair detection of antibodies to ustekinumab (ATU), as the ATU assay is not drug tolerant. This assay measures free ATU. This assay does not measure ATU bound to UTK (immunocomplexes).

 

Elevated rheumatoid factor (RF) may falsely increase results of ATU. During validation studies, negative ATU samples remained negative and positive ATU samples remained positive; however the quantitative result differed by more than 20% when compared to the non-RF spiked original samples. If patients are positive for RF, clinical correlation is recommended for ATU test interpretation.

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

1. Stelara (ustekinumab). Package insert: Prescribing information. Janssen Pharmaceuticals; revised 03/2020

2. Papamichael K, Cheifetz AS, Melmed GY, et al. Appropriate therapeutic drug monitoring of biologic agents for patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol 2019;17:1655-68 e3

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

Ustekinumab quantitation and anti-ustekinumab antibody measurements are performed using enzyme-linked immunosorbent assay (ELISA). Microwell strips are coated with a target antigen. Calibrators, controls, and patient samples are added to separate wells, allowing ustekinumab (UTK), or antibodies to ustekinumab (ATU), to bind to immobilized antigen. Unbound sample is washed away, and a conjugate is added to each well. A second incubation step allows the conjugate to bind to the UTK or ATU that has become attached to the microwells. After washing away the excess of unbound conjugate, the remaining enzyme activity is determined by adding a substrate and measuring the intensity of the color that develops in a spectrophotometer. The signal obtained is proportional to the amount of UTK or ATU in the patient sample.(Package inserts: Promonitor-UTK, Kit Product Number: 5371430000. Progenika Biopharma SA; Rev. 2, 4/2019; Promonitor-ANTI-UTK, Kit Product Number: 5381430000. Progenika Biopharma SA; Rev. 3, 4/2019)

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.

Monday, Thursday

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.

2 to 5 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.

80299

83520

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
USTEK Ustekinumab QN with Antibodies, S In Process
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
USQN Ustekinumab QN, S 87408-1
USTAB Ustekinumab Ab, S 87409-9

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