Test ID: ANAH2
Antinuclear Antibodies (ANA), HEp-2 Substrate, 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
Diagnosis of autoimmune diseases
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| ANAB | Antinuclear Antibody (Multiple), S | No | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
If ANA HEp-2 substrate screen is positive, then ANA (multiple) will be performed at an additional charge.
Method Name A short description of the method used to perform the test
Immunofluorescence Assay (IFA)
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
Antinuclear Antibodies (ANA)
FANA (Fluorescent Antinuclear Antibodies)
HEp-2
LE (Lupus Erythematosus)
Lupus Erythematosus (LE)
110011-ANAH2
Antinuclear Antibody
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
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 OK |
| Icterus | NA |
| 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 | |
| Ambient | 7 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Antinuclear antibodies are seen in a number of autoimmune disorders such as systemic lupus erythematosus; mixed connective tissue disease; rheumatoid arthritis; Sjogren syndrome; progressive systemic sclerosis; and calcinosis, Raynaud phenomenon, esophageal dysmotility, syndactyly, and telangiectasia (CREST) syndrome.
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 (titer of <1:40)
If positive, pattern will be reported and serum will be titered.
Interpretation Provides information to assist in interpretation of the test results
Anticentromere antibody (ACA) pattern:
-A positive test for ACA is strongly associated with calcinosis, Raynaud phenomenon, esophageal dysmotility, syndactyly, and telangiectasia (CREST) syndrome; in various reported clinical studies ACA occurs in 50% to 96% of patients with CREST syndrome.
-The presence of detectable levels of ACA may antedate the appearance of diagnostic clinical features of CREST syndrome, in some cases by several years.
The incidence of low-titer antinuclear antibodies (ANA) positives increases with age in normal individuals.
For positive ANA titers of > or =1:160, and for all ANA titers whenever there is a strong clinical suspicion of rheumatic disease, we recommend follow up using the assays ADNA/200043 DNA Double-Stranded (dsDNA) Antibodies, IgG, Serum and ENAE/200047 Antibody to Extractable Nuclear Antigen Evaluation, Serum.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is a laboratory diagnostic aid and by itself is not diagnostic. Positive results of this test may occur in apparently healthy people. Therefore, the results of this test must be interpreted by a medical authority in the context of the patient's total clinical condition.
Sera from systemic lupus erythematosus patients undergoing steroid therapy may give negative test results.
No definitive association between the pattern of nuclear fluorescence and any specific disease state is intended with this test.
Many drugs (eg, hydralazine, procainamide) may induce antinuclear antibodies production.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Bradwell AR, Stokes RP, Johnson GD: Atlas of HEp-2 patterns. San Diego, CA. The Binding Site, 1995, pp 9, 10, 19, 38-54
2. Fritzler MJ: Immunofluorescent antinuclear antibody test. In Manual of Clinical Laboratory Immunology. Fourth edition. Edited by NR Rose, EC De Macario. Washington, DC, ASM Press, 1992, pp 724-727
3. McCarty GA, Valencia DW, Fritzler MJ: Antinuclear antibodies. In Contemporary Techniques and Clinical Application to Connective Tissue Diseases. Oxford University Press, Inc, 1984, p 3
4. Stites DP, Terr AI: Basic and Clinical Immunology. Seventh edition. Edited by DP Stites, AI Terr. Norwalk, CT. Appleton & Lange, 1991, p 220
Method Description Describes how the test is performed and provides a method-specific reference
Autoantibodies in a test sample bind to antigens in the substrate (human epithelial cells, Hep-2). Washing removes excess serum from the substrate. Fluorescein-conjugated antiserum added to the substrate attaches to the bound autoantibody. After a second washing step to remove excess conjugate, the substrate is coverslipped and viewed for fluorescent patterns with a fluorescent microscope. Observation of a specific pattern on the substrate indicates the presence of autoantibodies in the test sample.(Package insert: Zeus Scientific ANA/Hep-2 Cell Culture IFA Test, System Product Series 2400/24000, April 27, 2004)
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 Friday. Sunday; 3rd shift
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.
86038-Screen
86039-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 |
|---|---|---|
| 86038 | Antinuclear Ab, HEp-2 Substrate, S | 8061-4 |
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