Test Catalog

Test Id : ANCA

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Cytoplasmic Neutrophil Antibodies, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating patients with clinical features of ANCA-associated vasculitis, specifically granulomatosus with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosus with polyangiitis

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Method Name
A short description of the method used to perform the test

Indirect Immunofluorescence (IIF)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Cytoplasmic Neutrophilic Ab, S

Aliases
Lists additional common names for a test, as an aid in searching

ANCA (Antineutrophil Cytoplasmic Antibodies)

Anti-Neutrophil Cytoplasmic Ab Test

Anti-Neutrophil Cytoplasmic Antibodies

Autoantibodies to Proteinase 3

c-ANCA (Anti-Neutrophil Cytoplasmic Antibodies)

cANCA (Antineutrophil Cytoplasmic Antibodies)

Cytoplasmic Neutrophil Antibodies

MPO (Myeloperoxidase Antibodies)

Myeloperoxidase Antibodies (MPO)

Neutrophil Cytoplasmic Antibodies

P-ANCA

pANCA (Perinuclear Antineutrophil Cytoplasmic Antibody)

Perinuclear anti-neutrophil cytoplasmic antibody (pANCA)

Perinuclear Antineutrophil Cytoplasmic Antibody (pANCA)

PR3 (Proteinase 3) Antineutrophil Cytoplasmic Antibodies

Proteinase 3 (PR3) Antineutrophil Cytoplasmic Antibodies

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Serum

Additional Testing Requirements

When used for diagnosis, it is recommended that specific tests for proteinase 3 antibodies and myeloperoxidase antibodies be performed first, with additional testing for anti-neutrophil cytoplasmic antibodies only needed in certain circumstances.(3) A testing algorithm based on these recommendations is available. For more information see VASC / Antineutrophil Cytoplasmic Antibodies Vasculitis Panel, Serum.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.8 mL

Collection Instructions: Centrifuge and aliquot serum into 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 1 of the following forms with the specimen:

-General Request (T239)

-Renal Diagnostics Test Request (T830)

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.

0.4 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

Evaluating patients with clinical features of ANCA-associated vasculitis, specifically granulomatosus with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosus with polyangiitis

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides are characterized by a pauci-immune inflammation within the walls of small blood vessels (1). There are 3 specific diseases which are identified as ANCA-associated vasculitides: microscopic polyangiitis (MPA), granulomatosus with polyangiitis (GPA), and eosinophilic granulomatosus with polyangiitis (EGPA). The serological hallmark of these disorders is the presence of ANCA, which are antibodies that bind to cytoplasmic antigens found in the granules of neutrophils (2). Patients with GPA frequently have antibodies specific for proteinase 3 (PR3), while individuals with MPA or EGPA are more likely to have antibodies that bind to myeloperoxidase (MPO). The presence of PR3-ANCA and MPO-ANCA can be detected using antigen-specific immunoassays or indirect immunofluorescence (IIF). IIF is performed most commonly using ethanol-fixed neutrophils. Using this substrate, anti-PR3 antibodies produce a granular cytoplasmic staining pattern, which is referred to as cANCA. In comparison, due to an artefact that is a result of the fixation process, anti-MPO antibodies display a perinuclear pattern, or pANCA.

 

Patients with suspected ANCA-associated vasculitis should be evaluated for the presence of PR3-ANCA, MPO-ANCA and ANCA by IIF. A consensus guideline published in 2017 recommends that patients with possible GPA or MPA be tested for PR3-ANCA and MPO-ANCA using antigen-specific immunoassays (3). ANCA by IIF should then be used in cases where there is a high degree of suspicion for GPA or MPA but the PR3-ANCA and MPO-ANCA testing is negative. This guideline also suggests that ANCA may be used in situations where a low positive PR3-ANCA or MPO-ANCA is detected, to improve specificity of the testing. The classification criteria for MPA, GPA and EGPA published by the American College of Rheumatology and the European Alliance of Associations for Rheumatology include PR3-ANCA and MPO-ANCA detected by either antigen-specific immunoassay or IIF (4-6). These classification criteria incorporate serological ANCA testing along with clinical symptoms, imaging, and biopsy results to determine a score which allows for the classification of the various ANCA-associated vasculitides.

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.

<1:4 (Negative)

Interpretation
Provides information to assist in interpretation of the test results

Positive results for proteinase 3 (PR3) antineutrophil cytoplasmic antibodies (ANCA) by antigen-specific immunoassay and cANCA by indirect immunofluorescence are consistent with the diagnosis of granulomatosus with polyangiitis, in patients with the appropriate clinical presentation.

 

Positive results for myeloperoxidase-ANCA by antigen-specific immunoassay and pANCA by indirect immunofluorescence are consistent with the diagnosis of microscopic polyangiitis or eosinophilic granulomatosus with polyangiitis, in patients with the appropriate clinical presentation.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

A positive result for proteinase 3 (PR3)- anti-neutrophil cytoplasmic antibody (ANCA), myeloperoxidase (MPO)-ANCA, or ANCA by IIF is not diagnostic for any ANCA-associated vasculitis and must be interpreted in the clinical context of the patient.

 

Negative results for PR3-ANCA, MPO-ANCA, and ANCA by indirect immunofluorescence (IIF) do not exclude the possibility of ANCA-associated vasculitis.

 

For monitoring disease activity, suggest ordering PR3 / Proteinase 3 Antibodies, Serum or MPO / Myeloperoxidase Antibodies, IgG, Serum

 

Antibodies specific for antigens other than PR3 and MPO may lead to nuclear, perinuclear or cytoplasmic staining on ethanol-fixed neutrophils. A positive or indeterminate pANCA or cANCA by IIF in the absence of a detectable PR3-ANCA or MPO-ANCA by antigen-specific immunoassay may indicate the presence of an antibody of unidentified specificity.

 

If ordered as a stand-alone test, all positive ANCA by IIF results should be confirmed for PR3-ANCA MPO-ANCA by solid-phase immunoassays.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Kitching AR, Anders HJ, Basu N, et al. ANCA-associated vasculitis. Nat Rev Dis Primers. 2020:6(1):71

2. Ramponi G, Folci M, De Santis M, et al. The biology, pathogenetic role, clinical implications, and open issues of serum anti-neutrophil cytoplasmic antibodies. Autoimmun Rev. 2021:20(3):102759

3. Bossuyt X, Cohen Tervaert W, Arimura Y, et al. Position paper: Revised 2017 international consensus on testing of ANCAs in granulomatosis with polyangiitis and microscopic polyangiitis. Nat Rev Rheumatol. 2017:13(11):683-692

4. Suppiah R, Robson JC, Grayson PC, et al. 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for microscopic polyangiitis. Ann Rheum Dis. 2022;81(3):321-326. doi:10.1136/annrheumdis-2021-221796

5. Robson JC, Grayson PC, Ponte C, et al. 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for granulomatosis with polyangiitis. Ann Rheum Dis. 2022;81(3):315-320. doi:10.1136/annrheumdis-2021-221795

6. Grayson PC, Ponte C, Suppiah R, et al. 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2022;81(3):309-314. doi:10.1136/annrheumdis-2021-221794

Method Description
Describes how the test is performed and provides a method-specific reference

Antibodies to cytoplasmic antigens in neutrophils are detected by an indirect immunofluorescent technique. Commercial and in-house slides prepared from human neutrophils are used as a substrate. IgG antibodies in serum specimens are detected after incubation of serum with the commercial and in-house slides by the addition of a fluorescein isothiocyanate-labeled antihuman IgG reagent. All patient specimens are initially screened at 1:4 and 1:8 dilutions.(Unpublished Mayo Method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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 Saturday

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.

3 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
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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.

86036 x2

86037-Titer (if appropriate)

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
ANCA Cytoplasmic Neutrophilic Ab, S 87427-1
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.
3114 c-ANCA In Process
3119 p-ANCA 17357-5

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports