Test Catalog

Test Id : FIBDD

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PROMETHEUS IBD sgi Diagnostic

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Overview

Test Catalog

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
FIBD1 PROMETHEUS IBD sgi Diagnostic, S No Yes
FIBD2 PROMETHEUS IBD sgi Diagnostic, B No Yes

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

Enzyme Linked Immunosorbent Assay (ELISA), Chemiluminescent, Immunofluorescence Assay (IFA), multiplexed Polymerase Chain Reaction (PCR) allelic discrimination assays.

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

PROMETHEUS IBD sgi Diagnostic

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

SGI

Specimen Type
Describes the specimen type validated for testing

Serum

Whole Blood EDTA

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

Requires both whole blood and serum

Note: Specimens must be shipped together

Note: Informed consent required from NYS clients

 

Blood:

Collect 2 mL lavender top EDTA whole blood. Ship refrigerate.

 

Serum:

Draw blood in a plain, red-top tube(s). (Serum gel tube is acceptable.) Spin down and send 2 mL of serum refrigerated.

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

Blood = 2 mL, Serum = 2 mL

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

Thawing** Cold OK; Warm OK
other reasons for rejection If both serum and EDTA whole blood are not received.

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
Ambient 7 days
Whole Blood EDTA Refrigerated (preferred) 21 days
Ambient 7 days

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

Combines serologic, genetic, and inflammation markers to help differentiate Inflammatory Bowel Disease (IBD) vs non-IBD and ulcerative colitis (UC) vs Crohn's disease (CD).

The PROMETHEUS IBD sgi Diagnostic is the 4th-generation IBD diagnostic test and the first and only test to combine serologic, genetic, and inflammation markers in the proprietary Smart Diagnostic Algorithm for added diagnostic clarity. This test aids healthcare providers in differentiating IBD vs non-IBD and CD vs UC in one comprehensive blood test. This assay includes 9 serological markers ASCA IgA, ASCA IgG and proprietary markers anti-Fla-X, anti-A4-Fla2, anti-CBir1, anti-OMPC, and DNAse-sensitive pANCA that helps identify patients with IBD and utilizes Smart Diagnostic Algorithm Technology to improve the predictive accuracy. Genetic susceptibility influences immune responses, and this assay includes evaluation of ATG16L1, STAT3, NKX2-3, and ECM1. Inflammatory markers include VEGF, ICAM-1, VCAM-1, CRP, SAA. While most other labs only offer assay values, PROMETHEUS IBD sgi Diagnostic provides added clarity in diagnosing IBD, UC, and CD.

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.

Testing is complete. Final report has been sent to the referring laboratory.

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

A proprietary algorithm is applied to the serologic, genetic, and inflammatory markers.

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

Referral

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 through 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.

6 to 8 days

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

Prometheus Laboratories, Inc.

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.

Test results should be used in conjunction with other clinical and diagnostic findings. The healthcare provider is responsible for the use of this information in the management of their patient. The test was developed, and it's performance characteristics determined by Prometheus. It has not been cleared or approved by the U.S. FDA. The test is used for clinical purposes and should not be regarded as investigational or for research. Prometheus is CAP-accredited (6805501) and CLIA-certified (05D0917432) as qualified to perform high complexity testing. The test may be covered by one or more U.S. pending or issued patents-refer to prometheuslabs.com

PROMETHEUS and IBD sgi Diagnostic, are trademarks or registered trademarks of Prometheus Laboratories Inc., San Diego, California. All other trademarks and service marks are the property of their respective owners.

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.

82397 x 4

83520 x 6

86255 x 2  

81479

86140

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
FIBDD PROMETHEUS IBD sgi Diagnostic 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.
Z2743 PROMETHEUS IBD sgi Diagnostic, S Unable to Verify
Z2744 PROMETHEUS IBD sgi Diagnostic, B Unable to Verify

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 | PHP Pdf | CMS 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