Test Id : IBDP2
Inflammatory Bowel Disease Serology Panel, Serum
    
        Useful For
            
                
                
                    
                    Suggests clinical disorders or settings where the test may be helpful
                
            
    
    Distinguishing between ulcerative colitis and Crohn disease in patients for whom the specific diagnosis is unclear based on endoscopic, pathologic, and imaging evaluations
This test is not useful for determining the extent of disease in patients with inflammatory bowel disease or determining the response to disease-specific therapy including surgical resection of diseased intestine.
    
        Profile Information
            
                
                
                    
                    A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
                
            
    
    | Test Id | Reporting Name | Available Separately | Always Performed | 
|---|---|---|---|
| ANCA2 | Cytoplasmic Neutrophilic Ab IBD, S | No | Yes | 
| SCERA | Saccharomyces cerevisiae Ab, IgA, S | Yes | Yes | 
| SCERG | Saccharomyces cerevisiae Ab, IgG, S | Yes | Yes | 
    
        Testing Algorithm
            
                
                
                    
                    Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
                
            
    
    For more information see Inflammatory Bowel Disease Diagnostic Testing Algorithm.
For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.
    
        Method Name
            
                
                
                    
                    A short description of the method used to perform the test
                
            
    
    SCERA, SCERG: Enzyme-Linked Immunosorbent Assay (ELISA)
ANCA2: Indirect Immunofluorescent Assay (IFA)
    
        NY State Available
            
                
                
                    
                    Indicates the status of NY State approval and if the test is orderable for NY State clients.
                
            
    
    
    
        Reporting Name
            
                
                
                    
                    Lists a shorter or abbreviated version of the Published Name for a test
                
            
    
    
    
        Aliases
            
                
                
                    
                    Lists additional common names for a test, as an aid in searching
                
            
    
    ASCA (Saccharomyces cerevisiae Antibody)
Crohn's Disease
IBD
Neutrophil Specific Ab
p-ANCA
Regional Enteritis
Ulcerative Colitis
    
        Testing Algorithm
            
                
                
                    
                    Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
                
            
    
    For more information see Inflammatory Bowel Disease Diagnostic Testing Algorithm.
For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.
    
        Specimen Type
            
                
                
                    
                    Describes the specimen type validated for testing
                
            
    
        Serum
    
        Specimen Required
            
                
                
                    
                    Defines the optimal specimen required to perform the test and the preferred volume to complete testing
                
            
    
    Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
    
        Special Instructions
            
                
                
                    
                    Library of PDFs including pertinent information and forms related to the test
                
            
    
    
    
        Forms
    
    If not ordering electronically, complete, print, and send Gastroenterology and Hepatology Test Request (T728) with the specimen.
    
        Specimen Minimum Volume
            
                
                
                    
                    Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
                
            
    
    0.8 mL
    
        Reject Due To
            
                
                
                    
                    Identifies specimen types and conditions that may cause the specimen to be rejected
                
            
    
    | Gross hemolysis | Reject | 
| Gross lipemia | Reject | 
| Gross icterus | OK | 
| Heat-treated specimen | Reject | 
    
        Specimen Stability Information
            
                
                
                    
                    Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
                
            
    
    | Specimen Type | Temperature | Time | Special Container | 
|---|---|---|---|
| Serum | Refrigerated (preferred) | 21 days | |
| Frozen | 21 days | 
    
        Useful For
            
                
                
                    
                    Suggests clinical disorders or settings where the test may be helpful
                
            
    
    Distinguishing between ulcerative colitis and Crohn disease in patients for whom the specific diagnosis is unclear based on endoscopic, pathologic, and imaging evaluations
This test is not useful for determining the extent of disease in patients with inflammatory bowel disease or determining the response to disease-specific therapy including surgical resection of diseased intestine.
    
        Testing Algorithm
            
                
                
                    
                    Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
                
            
    
    For more information see Inflammatory Bowel Disease Diagnostic Testing Algorithm.
For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.
    
        Clinical Information
            
                
                
                    
                    Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
                
            
    
    Inflammatory bowel disease (IBD) refers to 2 diseases - ulcerative colitis (UC) and Crohn disease (CD), both of which result from chronic inflammation in the gastrointestinal (GI) tract.(1) CD is characterized by chronic diarrhea, abdominal pain, and fatigue.(2) In comparison, UC frequently presents with bloody diarrhea that is of an urgent nature.(3) Inflammation in UC most frequently affects the rectum and proximal colon, and presents with continue mucosal involvement. In CD, inflammation can affect almost any area of the GI tract and is usually evidenced as patchy, transmural lesions.
Diagnosis of IBD is primarily based on clinical evaluation, endoscopy with biopsy, and imaging studies.(4) Because CD and UC are characterized by GI inflammation, fecal calprotectin can be used to differentiate IBD from noninflammatory conditions such as irritable bowel syndrome (IBS). Fecal calprotectin is useful in excluding IBD as a diagnosis and avoiding unnecessary endoscopic or imaging procedures.
CD and UC are associated with the presence of various antimicrobial and autoantibodies.(5) Patients with UC often have measurable antineutrophil cytoplasmic antibodies (ANCA), which react with as yet uncharacterized target antigens in human neutrophils; in contrast, patients with CD often have measurable IgA and/or IgG antibodies, which react with cell wall mannan of Saccharomyces cerevisiae. Despite these associations, current guidelines indicate that testing for these antibodies is not sufficiently sensitive for use in the diagnosis of IBD.(2,3) Rather, these antibodies should be limited to distinguishing between CD and UC in cases where the specific diagnosis is unclear based on pathologic and imaging studies.
    
        Reference Values
            
                
                
                    
                    Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
                
            
    
    Saccharomyces cerevisiae ANTIBODY, IgA
Negative: <20.0 RU/mL
Positive: > or =20.0 RU/mL
Saccharomyces cerevisiae ANTIBODY, IgG
Negative: <20.0 RU/mL
Positive: > or =20.0 RU/mL
CYTOPLASMIC NEUTROPHIL ANTIBODIES, INFLAMMATORY BOWEL DISEASE PANEL, SERUM
Negative (not detectable)
    
        Interpretation
            
                
                
                    
                    Provides information to assist in interpretation of the test results
                
            
    
    The presence of antineutrophil cytoplasmic antibodies in the absence of IgA and IgG anti-Saccharomyces cerevisiae antibodies is consistent with the diagnosis of ulcerative colitis; the presence of IgA and IgG ASCA in the absence of ANCA is consistent with Crohn disease.
    
        Cautions
            
                
                
                    
                    Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
                
            
    
    Results from this test should not be exclusively relied upon to establish the diagnosis of ulcerative colitis (UC) or Crohn disease (CD) or to distinguish between these 2 diseases.
Some patients with CD have detectable antineutrophil cytoplasmic antibodies (ANCA), and some patients with UC have detectable IgA and/or IgG anti-Saccharomyces cerevisiae antibodies (ASCA). Some patients with UC or CD do not have detectable ANCA, IgA ASCA, or IgG ASCA.
ANCA results may be reported as indeterminate if interfering antinuclear antibodies (ANA) are present.
    
        Clinical Reference
            
                
                
                    
                    Recommendations for in-depth reading of a clinical nature
                
            
    
    1. Rose NR, Mackay IR, eds: Inflammatory bowel diseases. In: The Autoimmune Diseases. Elsevier; 2008
2. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: Management of crohn's disease in adults. Am J Gastroenterol. 2018;113(4):481-517
3. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: Ulcerative colitis in adults. Am J Gastroenterol. 2019;114(3):384-413
4. Clark C, Turner J. Diagnostic modalities for inflammatory bowel disease: Serologic markers and endoscopy. Surg Clin North Am. 2015;95(6):1123-1141
5. Zhou G, Song Y, Yang W, et al. ASCA, ANCA, ALCA and many more: Are they useful in the diagnosis of inflammatory bowel disease? Dig Dis. 2016;34:90-97
    
        Method Description
            
                
                
                    
                    Describes how the test is performed and provides a method-specific reference
                
            
    
    IgA or IgG antibodies to Saccharomyces cerevisiae antigens (ASCA) are measured by commercial, microtiter enzyme immunoassays. These assays use polystyrene microtiter plates coated with purified mannan from the cell wall of S cerevisiae to capture antibodies from patient sera, and horseradish peroxidase-conjugated anti-IgA or anti-IgG antibodies to detect ASCA. Results of the tests for ASCA are reported in relative units per milliliter (RU/mL).(Package inserts: Anti-Saccharomyces cerevisiae ELISA (IgA), 5/2011; Anti-Saccharomyces cerevisiae ELISA (IgG), EUROIMMUN Medizinische Labordiagnostika AG; 5/2011)
Antineutrophil cytoplasmic antibodies (ANCA) are detected qualitatively using an in-house developed method with a substrate of ethanol-fixed, human neutrophils and fluorescein conjugated, antihuman IgG antibody as a detection protein. Results of the test for ANCA are reported as positive, negative, or indeterminate.(Unpublished Mayo method)
    
        PDF Report
            
                
                
                    
                    Indicates whether the report includes an additional document with charts, images or other enriched information
                
            
    
    
    
        Day(s) Performed
            
                
                
                    
                    Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
                
            
    
    Monday through Friday
    
        Report Available
            
                
                
                    
                    The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
                
            
    
    
    
        Specimen Retention Time
            
                
                
                    
                    Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
                
            
    
    
    
        Performing Laboratory Location
            
                
                
                    
                    Indicates the location of the laboratory that performs the test
                
            
    
    
    
        Fees :
            
                
                
                    
                    Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
                
            
    
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- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
    
        Test Classification
            
                
                
                    
                    Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
                
            
    
    This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.
    
        CPT Code Information
            
                
                
                    
                    Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
                
            
    
    CPT codes are provided by the performing laboratory.
86671 x 2
86036
    
        LOINC® Information
            
                
                
                    
                    Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
                
            
    
    | Test Id | Test Order Name | Order LOINC Value | 
|---|---|---|
| IBDP2 | Inflammatory Bowel Disease Panel, S | 87551-8 | 
| Result Id | Test Result Name | Result LOINC Value 
                                        
                                        Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
                                     | 
|---|---|---|
| 610030 | Cytoplasmic Neutrophilic Ab IBD, S | 17355-9 | 
| 614542 | ANCA2 Interpretation | 49308-0 | 
| SCERA | Saccharomyces cerevisiae Ab, IgA, S | 47320-7 | 
| SCERG | Saccharomyces cerevisiae Ab, IgG, S | 47321-5 |