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HelpTest ID FIBDD PROMETHEUS IBD sgi Diagnostic
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 DiagnosticSpecimen Type
SerumWhole Blood EDTA
Specimen Minimum Volume
Blood = 2 mL, Serum = 2 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 21 days |
| Ambient | 7 days | |
| Whole Blood EDTA | Refrigerated (preferred) | 21 days |
| Ambient | 7 days |
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.
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 daysPerforming Laboratory
Prometheus Laboratories, Inc.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.CPT Code Information
82397 x 4
83520 x 6
86255 x 2
81479
86140