Test ID: ANCA
Cytoplasmic Neutrophil Antibodies, Serum
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Antineutrophil cytoplasmic antibodies (cANCA and pANCA):
-Evaluating patients suspected of having autoimmune vasculitis (both Wegener granulomatosis [WG] and microscopic polyangiitis)
cANCA titer:
-May be useful for monitoring treatment response in patients with WG (systemic or organ-limited disease); increasing titer suggests relapse of disease, while a decreasing titer suggests successful treatment
When used for diagnosis it is recommended that specific tests for proteinase 3 (PR3) ANCA and myeloperoxidase (MPO) ANCA be performed in addition to testing for cANCA and pANCA.(2) This panel of tests is available by ordering the VASC/83012 Antineutrophil Cytoplasmic Antibodies Vasculitis Panel, Serum.
Method Name A short description of the method used to perform the test
Indirect Immunofluorescence
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
ANCA (Antineutrophil Cytoplasmic Antibodies)
ANCA (Wegener's)
Anti-Neutrophil Cytoplasmic Ab Test
Anti-Neutrophil Cytoplasmic Antibodies
Anticytoplasmic Antibody
Anticytoplasmic Autoantibodies
Antineutrophil Cytoplasmic Antibodies (ACPA)
Autoantibodies to Proteinase 3
c-ANCA (Anti-Neutrophil Cytoplasmic Antibodies)
cANCA (Antineutrophil Cytoplasmic Antibodies)
Cytoplasmic Antibody
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
Wegener's Disease
Wegener's Granulomatosis
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.5 mL
Additional Information: This test should not be mistaken for granulocyte antibodies.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross OK |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 14 days |
| Frozen | 14 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Antineutrophil cytoplasmic antibodies (ANCA) can occur in patients with autoimmune vasculitis including Wegener's granulomatosis (WG), microscopic polyangiitis (MPA), or organ-limited variants thereof such as pauci-immune necrotizing glomerulonephritis.(1) Detection of ANCA is a well-established diagnostic test for the evaluation of patients suspected of having autoimmune vasculitis. ANCA react with enzymes in the cytoplasmic granules of human neutrophils including proteinase 3 (PR3), myeloperoxidase (MPO), elastase, and cathepsin G. Antibodies to PR3 occur in patients with WG (both classical WG and WG with limited end-organ involvement) and produce a characteristic pattern of granular cytoplasmic fluorescence on ethanol-fixed neutrophils called the cANCA pattern. Antibodies to MPO occur predominately in patients with MPA and produce a pattern of perinuclear cytoplasmic fluorescence on ethanol-fixed neutrophils called the pANCA pattern.
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.
Negative
If positive for cANCA, results are titered.
Interpretation Provides information to assist in interpretation of the test results
Positive results for antineutrophil cytoplasmic antibodies (cANCA or pANCA) are consistent with the diagnosis of Wegener granulomatosis (WG), either systemic WG with respiratory and renal involvement or limited WG with more restricted end-organ involvement. Positive results for pANCA are consistent with the diagnosis of autoimmune vasculitis including microscopic polyangiitis (MPA) or pauci-immune necrotizing glomerulonephritis. Sequential measurements of titers of cANCA may be useful to indicate the clinical course of patients with WG. Changes in titer of > or =2 serial dilutions are considered significant.(3) In patients with very low levels of cANCA, the immunofluorescent staining pattern may mimic the pANCA pattern. In patients with MPA, monitoring of disease activity may be performed by measuring MPO ANCA (MPO/80389 Myeloperoxidase Antibodies, IgG, Serum).
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Current recommendations suggest that testing for antineutrophil cytoplasmic antibodies (ANCA) by immunofluorescence assay should not be relied upon exclusively to establish the diagnosis of Wegener's granulomatosis (WG) or microscopic polyangiitis (MPA) (see Interpretation).
Results for cANCA testing are titered if positive (1:4, 8, 16, 32, etc.). If positive for pANCA, results are reported as positive. Changes in titer of cANCA should not be relied upon exclusively to judge the disease activity of patients with WG or to determine the response to treatment. A decreasing titer of cANCA may lag behind the induction of clinical remission by several weeks in a patient with WG and, a detectable titer of cANCA may persist indefinitely despite induction of a stable clinical remission of disease. Conversely, a slight increase in the titer of cANCA should not be interpreted to mean an exacerbation of disease without further clinical and laboratory evidence of disease progression.
The presence of an antinuclear antibody may mimic a pANCA on ethanol-fixed neutrophils.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Russell KA, Wiegert E, Schroeder DR, et al: Detection of anti-neutrophil cytoplasmic antibodies under actual clinical testing conditions. Clin Immunol 2002:103;196-203
2. Savige J, Gillis D, Benson E, et al: International consensus statement on testing and reporting of antineutrophil cytoplasmic antibodies (ANCA). Am J Clin Pathol 1999:111;507-513
3. Specks U, Homburger HA, DeRemee RA: Implications of cANCA testing for the classification of Wegener’s Granulomatosis: performance of different detection systems. Adv Exp Med Biol 1993:336;65-70
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 isothiocyante (FITC)-labeled antihuman IgG reagent. All patient specimens are initially screened at 1:4 and 1:8 dilutions.(Package insert: NOVA Lite ANCA. Inova Diagnostics, Inc. San Diego, CA)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday; 11 a.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86255-Screen
86256-Titer (if appropriate)
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 3114 | c-ANCA | 35279-9 |
| 3119 | p-ANCA | 17357-5 |
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