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PROMETHEUS® IBD sgi Diagnostic™
- SBMF No:
- Performance Lab Name:
Prometheus Laboratories Inc
- Test Mnemonic:
See Medical Necessity Guide
Local Coverage Determination (LCD): Molecular Diagnostic Testing (L33219)
- CPT Code:
81479x4; 82397x3; 83520x8; 86140; 88347x2
- Ref Lab Test No:
- Test Includes:
ASCA IgA ELISA; ASCA IgG ELISA; Anti-OmpC IgA ELISA; Anti-CBir1 IgG ELISA; Anti-A4-Fla2 IgG ELISA; Anti-FlaX IgG ELISA; IBD-specific pANCA AutoAntibody ELISA; IBD Specific pANCA IFA Perinuclear Pattern; IBD Specific pANCA IFA DNAse Sensitivity; ATG16L1 SNP (rs2241880); ECM1 SNP (rs3737240); NKX2-3 SNP (rs10883365); STAT3 SNP (rs744166); ICAM-1; VCAM-1; VEGF; CRP; SAA
- Also See:
44237 IBD Profile
- Patient Prep:
NOTE: The Medical Foundation does not provide insurance filing or patient billing services for tests referred to Prometheus Laboratories. Orders from hospital clients will be billed to the client’s account. Orders from non-hospital clients will be billed to the patient or insurance by Prometheus Laboratories. Submit specimens with a Prometheus Laboratories requisition, a patient demographic information sheet, and copies of insurance cards (front and back).
- Spec Collect:
Gold top (SST) or Red top (serum) tube AND Lavender top (EDTA) tube. Mix by inverting tubes 8 to 10 times.
Two specimens (Serum AND Whole Blood) are required.
- Spec Process:
SST / Serum: Allow specimen to clot completely at room temperature. Separate from cells and transfer 2 mL serum to a plastic transport tube.
EDTA: Transport 5 mL whole blood in the original collection tube. (Min: 2 mL)
- Spec Store Transport:
Room temperature. Also acceptable: Refrigerated.
- Spec Stability:
Room Temperature: 7 days
Refrigerated: 21 days
- Spec Reject:
- Spec Remarks:
Minimum specimen volume for genetic testing may vary with the WBC count.
Enzyme-Linked Immunosorbent Assay (ELISA); Chemiluminescent Immunoassay (CIA); Indirect Immunofluorescence (IFA); Polymerase Chain Reaction (PCR)
The first and only test that combines serologic, genetic and inflammation markers in a proprietary Smart Diagnostic Algorithm to provide added IBD diagnostic clarity. This test will help physicians differentiate IBD vs. non-IBD and CD vs. UC in one comprehensive blood test.
- Reference Range:
General Test Information:
Patient test results are based on the Smart Diagnostic Algorithm which interprets complex patterns among assay values from a combination of serologic, genetic, and inflammatory markers.
The test was developed using 1,520 samples from well-characterized IBD patients and non-IBD disease and healthy controls.
Serology Results: Assay Reference Value ASCA IgA ELISA <8.5 EU/mL ASCA IgG ELISA <17.8 EU/mL Anti‑OmpC IgA ELISA <10.9 EU/mL Anti‑CBir1 IgG ELISA <78.4 EU/mL Anti‑A4‑Fla2 IgG ELISA <44.8 EU/mL Anti‑FlaX IgG ELISA <33.4 EU/mL IBD‑specific pANCA AutoAntibody ELISA <19.8 EU/mL IBD Specific pANCA IFA Perinuclear Pattern Not Detected IBD Specific pANCA IFA DNAse Sensitivity Not Detected Genetics Results: Assay Reference Value ATG16L1 SNP (rs2241880) No Mutation Detected ECM1 SNP (rs3737240) No Mutation Detected NKX2‑3 SNP (rs10883365) No Mutation Detected STAT3 SNP (rs744166) Mutation Detected Inflammation Results: Assay Reference Value ICAM‑1 <0.54 µg/mL VCAM‑1 <0.68 µg/mL VEGF <345 pg/mL CRP <13.2 mg/L SAA <10.9 mg/L
Overall performance of PROMETHEUS IBD sgi Diagnostic: Sensitivity IBD 74%, CD 89%, UC 98%; Specificity IBD 90%, CD 81%, UC 84%. Smart Diagnostic Algorithm technology was trained (n=1083; 39% CD, 21% UC, 29% disease controls, and 11% healthy controls) and validated (n=437; 35% CD, 23% UC, 28% disease controls, and 14% healthy controls) from results of serology, genetic, and inflammation assays.
A test result is the product of a collective evaluation of all individual assays by a complex algorithm. From this, it is possible to produce a result of "Pattern Not Consistent with IBD" when one or more assay values are above the specified reference value. It is also possible to produce a result of "Pattern Consistent with IBD" when all individual assay values are below the specified reference value.
Reference values have been calculated based on a population of non-IBD controls.
A result of "Inconclusive for Crohn's Disease vs. Ulcerative Colitis" is reported for patient samples exhibiting a pattern consistent with IBD but not conclusive for a Crohn's Disease or Ulcerative Colitis pattern determination.
References available from Prometheus Laboratories on request.
Prometheus diagnostic services provide important information to aid in the diagnosis and management of certain diseases. Test results should be used with other clinical and diagnostic findings to make a diagnosis. This test was developed and its performance characteristics determined by Prometheus Laboratories Inc. It has not been cleared or approved by the U.S. Food and Drug Administration. This test may be covered by one or more US pending or issued patents - see prometheuslabs.com for details.
- Test Type: