IBD SGI Diagnostic Panel
Label Mnemonic: IBDSGI
Epic code: LAB3400
Downtime form: A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery
Commercial Mailout Laboratory
6240-8 RCP
356-8593
Specimen(s):
Serum and EDTA
Collection Medium:
and
Red top tube 5 mL (Clot Activator) Lavender top tube 3 mL (EDTA)
Minimum:
2.0 mL serum in red top tube + 2.0 mL whole blood in (EDTA) lavender top tube. Both tube types are required.
Turn Around Time:
3-4 days upon receipt at reference laboratory
Reference Range:
NOTE: Patient test results are based on the Smart Diagnostic 
Algorithm which interprets patterns among the assay and values.

  ASCA IgA ELISA:                              <9.2 EU/mL
  ASCA IgG ELISA:                              <11.9 EU/mL
  Anti-OmpC IgA ELISA:                         <11.3 EU/mL
  Anti-CBir1 ELISA:                            <35.4 EU/mL
  Anti-A4-Fla2 IgG ELISA:                      <32.4 EU/mL
  Anti-FlaX IgG ELISA:                         <36.0 EU/ml
  IBD Specific pANCA IFA Perinuclear Pattern:  Not Detected
  IBD Specific pANCA IFA DNAse Sensitivity:    Not Detected
  ATG16L1 SNP (rs2241880):                     Variant Not Detected
  EMC1 SNP (rs3737240):                        Variant Not Detected
  NKX2-3 (rs10883365):                         Variant Not Detected
  STAT3 SNP (rs744166):                        Variant Detected
  ICAM-1:                                      <0.52 μg/mL
  VCAM-1:                                      <0.75 μg/mL
  VEGF:                                        <393 pg/mL
  CRP:                                         <13.4 mg/L
  SAA:                                         <22.9 mg/L
Comments:
This test aids in differentiating IBD vs non-IBD and Crohn's Disease vs Ulcerative Colitis in one comprehensive blood test.

This assay includes 9 serological markers including the proprietary 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, VCAM, CRP, SAA. While most other labs only offer assay values, the reference laboratory provides added clarity in diagnosing IBD, UC, and CD.

The reference laboratory 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 and prognosis. This test was developed and its performance characteristics determined by the reference laboratory and has not been cleared or approved by the U.S. Food and Drug Administration.
Methodology:
Enzyme-linked immunosorbent Assays (ELISA) and indirect immunofluorescent assays
CPT Code:
81479 x4,83520 x6,82397 x4,86140, 88346 x1, 88350 x1