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Prometheus® Crohn's Prognostic
Test Code90808
CPT Codes
81599
Includes
ASCA IgA ELISA
ASCA IgG ELISA
Anti-OmpC(a) IgA ELISA
Anti-CBir1(a) ELISA
Anti-I2 ELISA
IFA Perinuclear Pattern
DNAse Sensitivity
R702W [C2104T] Mutations
G908R [G2722C] Mutations
L1007fs [3020insC] Mutations
ASCA IgG ELISA
Anti-OmpC(a) IgA ELISA
Anti-CBir1(a) ELISA
Anti-I2 ELISA
IFA Perinuclear Pattern
DNAse Sensitivity
R702W [C2104T] Mutations
G908R [G2722C] Mutations
L1007fs [3020insC] Mutations
Preferred Specimen
2 mL serum collected in a red-top tube (no gel) and
2 mL whole blood collected in an EDTA (lavender-top) tube
2 mL whole blood collected in an EDTA (lavender-top) tube
Minimum Volume
2 mL
Instructions
Specimens must be labeled with patient's name and date of collection. Unlabeled specimens will not be accepted for testing. Serum and EDTA whole blood specimens must be shipped together in the same container. Shipment within 7 days of collection and storage at or below room temp is recommended. Shipping room or refrigerated temperature is acceptable. Do not freeze specimens.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
Refrigerated: 7 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Specimens will be rejected if whole blood and serum are not drawn and received together
Methodology
DNA Probe • Indirect Immunofluorescence Assay • Nucleic Acid Amplification (NAT) • Interpretation • Enzyme-Linked Immunosorbent Assay (ELISA)
FDA Status
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. Prometheus Laboratories Inc. is a CAP-accredited CLIA laboratory.
Setup Schedule
Set up: Daily; Report available: 7 days
Reference Range
See Laboratory Report
Clinical Significance
This test combines proprietary serologic and genetic (serogenetic) markers in a logistic regression model to provide individualized probabilities for developing disease complications after diagnosis in patients with Crohn's disease. This test may allow physicians to stratify their CD patients according to their risks of developing complications over time and personalize the disease treatment plan for the patients.
Performing Laboratory
Prometheus Laboratories, Inc.
9410 Carroll Park Drive
San Diego, CA 92121