Test Catalog

Test Id : FCZAC

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Certolizumab and Anti-Certolizumab Antibody, DoseASSURE CTZ

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Overview

Test Catalog

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

Provides certolizumab drug concentration and anti-certolizumab antibodies in order to optimize treatment and facilitate clinical decision-making.

 

This assay may be helpful in any patient on certolizumab therapy for Crohn's disease, psoriasis, or other autoimmune condition.

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

Electrochemiluminescence immunoassay (ECLIA); Surface Plasmon Resonance

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

Certolizumab and Anti-Certo Ab

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

FCZAC

Ant-TNF drug

Biologic drug level and anti-drug antibody

Biologic monitoring

Cimzia

DoseASSURE

Immunogenicity testing

Therapeutic drug monitoring (TDM)

TNF inhibitor

Anti-TNF

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

Specimen Type: Serum

Container/Tube: Red or SST

Specimen Volume: 2 mL

Collection Instructions: Draw blood in a plain red-top tube(s), serum gel tube(s) is acceptable. Spin down and send 2 mL of serum frozen in a plastic vial.

To avoid delays in turnaround time when requesting multiple tests, please submit separate frozen specimens for each test requested.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.60 mL (Note: This volume does not allow for repeat testing.)

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

Gross hemolysis Gross reject; Mild OK
Gross lipemia Reject
Gross icterus NA
Other/Tissue/Swab Specimens other than indicated

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 Frozen (preferred) 14 days
Refrigerated 14 days

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

Provides certolizumab drug concentration and anti-certolizumab antibodies in order to optimize treatment and facilitate clinical decision-making.

 

This assay may be helpful in any patient on certolizumab therapy for Crohn's disease, psoriasis, or other autoimmune condition.

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.

Certolizumab:

Quantitation Limit: <1.0 ug/mL

 

Results of 1 ug/mL or higher indicate detection of certolizumab

 

Anti-Certolizumab Antibody:

Quantitation Limit: <40 ng/mL

 

Results of 40 ng/mL or higher indicate detection of anti-certolizumab pegol antibodies.

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

As with other biologics, the optimal certolizumab concentration depends upon patient-specific factors including co-morbidities, disease, and desired therapeutic endpoint.

 

Trough blood collection (just before the next dose) is suitable because target ranges and therapeutic cut-offs are established by clinical studies that typically evaluate trough concentrations.

 

Therefore, the timing of specimen collection should be considered when interpreting drug concentrations. Drug half-life should be factored in when evaluating non-trough concentrations.

 

Adequate drug trough levels do not guarantee clinical efficacy since primary non-response can be due to mechanistic failure.

 

Lack of clinical response may be due to inadequate drug exposure, immunogenicity or mechanistic mismatch. Positive anti-certolizumab antibodies should be interpreted in the context of the concomitant free certolizumab drug level.

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.

Tuesday

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.

10-21 days

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

Esoterix Endocrinology

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 account representative. 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.

These tests were developed and their performance characteristics determined by LabCorp. They have not been cleared or approved by the 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

82397

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
FCZAC Certolizumab and Anti-Certo Ab Not Provided
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.
Z5637 Certolizumab 87404-0
Z5638 Anti-Certolizumab Antibody 87405-7

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