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Test Code LABXPIBDS PROMETHEUS IBD sgi Diagnostic

Additional Codes

XPIBDS


Specimen Required


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.


Profile Information

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

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

Reporting Name

PROMETHEUS IBD sgi Diagnostic

Specimen Type

Serum
Whole Blood EDTA

Specimen Minimum Volume

Blood = 2 mL, Serum = 2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
  Ambient  7 days
Whole Blood EDTA Refrigerated (preferred) 21 days
  Ambient  7 days

Reject Due To

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

Reference Values

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

Day(s) Performed

Monday through Friday

Report Available

6 to 8 days

Performing Laboratory

Prometheus Laboratories, Inc.

CPT Code Information

82397 x 4

83520 x 6

86255 x 2  

81479

86140

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FIBDD PROMETHEUS IBD sgi Diagnostic Not Provided

 

Result ID Test Result Name Result LOINC Value
Z2743 PROMETHEUS IBD sgi Diagnostic, S Unable to Verify
Z2744 PROMETHEUS IBD sgi Diagnostic, B Unable to Verify

Clinical Information

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.

Method Description

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

Test Classification

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.