Home
HelpTest Code IM_04 Antinuclear Antibodies, HEp-2 Substrate, with Reflex, Comment
Specimen Required
Only orderable as part of a profile. For more information see RFLXP / Antinuclear Antibodies, HEp-2, Reflex Panel.
Useful For
Interpretation for the evaluation of patients suspected of having systemic autoimmune rheumatic disease (antinuclear antibody-associated rheumatic diseases or connective tissue diseases), especially systemic lupus erythematosus, mixed connective tissue disease and Sjogren syndrome
Method Name
Only orderable as part of a profile. For more information see RFLXP / Antinuclear Antibodies, HEp-2, Reflex Panel.
Technical Interpretation
Reporting Name
Antinuclear Ab,HEp-2,reflex CommentSpecimen Type
SerumSpecimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 21 days |
| Frozen | 28 days |
Reference Values
Only orderable as part of a profile. For more information see RFLXP / Antinuclear Antibodies, HEp-2, Reflex Panel.
An interpretation will be provided.
Interpretation
Interpretive comments are provided.
Presence of anti-cellular antibody (also known as antinuclear antibody) is a feature of systemic autoimmune rheumatic diseases such as systemic lupus erythematosus, mixed connective tissue disease, Sjogren syndrome, and systemic sclerosis and some inflammatory myopathies (dermatomyositis, anti-synthetase syndrome and necrotizing autoimmune myopathy). It may also be of diagnostic relevance in patients with autoimmune liver diseases.
Patients' sera are screened at 1:80. The following nuclear patterns and their titers are reported: centromere, homogeneous, nuclear dots, nucleolar, speckled, fine dense speckled (also referred to as DFS70), and proliferating cell nuclear antigen (PCNA). If observed, the following cytoplasmic patterns are reported: reticular/AMA (antimitochondrial antibody), cytoplasmic speckled, fibrillar, polar/Golgi-like, or rods and rings. The spindle fiber and centrosome mitotic patterns are also reported if observed. Reported patterns may help guide differential diagnosis, although they may not be specific for individual antibodies or diseases. Negative results do not necessarily rule out systemic autoimmune rheumatic disease.
The anti-cellular antibody test lacks diagnostic specificity and is associated with some cancers, infectious, and inflammatory conditions, with variable prevalence in healthy individuals. The lack of diagnostic specificity requires confirmation of positive results using associated antibody tests such as those targeting extractable nuclear antigens.
Clinical Reference
1. Agmon-Levin N, Damoiseaux J, Kallenberg C, et al. International recommendations for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. Ann Rheum Dis. 2014;73(1):17-23
2. Chan EK, Damoiseaux J, Carballo OG, et al. Report of the First International Consensus on Standardized Nomenclature of Antinuclear Antibody HEp-2 Cell Patterns 2014-2015. Front Immunol. 2015;6:412
3. Bossuyt X, De Langhe E, Borghi MO, Meroni PL. Understanding and interpreting antinuclear antibody tests in systemic rheumatic diseases. Nat Rev Rheumatol. 2020;16(12):715-726
4. International Consensus on ANA Patterns. Nomenclature and Classification Tree. ICAP; 2021 Accessed April 21, 2026. Available at www.anapatterns.org/trees.php
5. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-172
6. Younossi ZM, Bernstein D, Shiffman ML, et al. Diagnosis and management of primary biliary cholangitis. Am J Gastroenterol. 2019;114(1):48-63
7. Aringer M, Costenbader K, Daikh D, et al. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Arthritis Rheumatol. 2019;71(9):1400-1412
8. Naides SJ, Genzen JR, Abel G, Bashleben C, Ansari MQ. Antinuclear antibodies testing method variability: A survey of participants in the College of American Pathologists' Proficiency Testing Program. J Rheumatol. 2020;47(12):1768-1773
9. Van Hoovels L, Broeders S, Chan EKL, et al. Current laboratory and clinical practices in reporting and interpreting anti-nuclear antibody indirect immunofluorescence (ANA IIF) patterns: results of an international survey. Auto Immun Highlights. 2020;11(1):17
10. Tebo AE, Schmidt RL, Kadkhoda K, et al. The antinuclear antibody HEp-2 indirect immunofluorescence assay: a survey of laboratory performance, pattern recognition and interpretation. Auto Immun Highlights. 2021;12(1):4
11. Choi MY, Clarke AE, St Pierre Y, et al. Antinuclear antibody-negative systemic lupus erythematosus in an international inception cohort. Arthritis Care Res (Hoboken). 2019;71(7):893-902
12. Nandiwada SL, Peterson LK, Mayes MD, et al. Ethnic differences in autoantibody diversity and hierarchy: More clues from a US cohort of patients with systemic sclerosis. J Rheumatol. 2016;43(10):1816-1824
13. Silva MJ, Dellavance A, Baldo DC, et al. Interkit Reproducibility of the Indirect Immunofluorescence Assay on HEp-2 Cells Depends on the Immunofluorescence Reactivity Intensity and Pattern. Front Immunol. 2022;12:798322
Day(s) Performed
Monday through Saturday
Report Available
3 to 4 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
Not ApplicableLOINC Code Information
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| IM_04 | Antinuclear Ab,HEp-2,reflex Comment | 77202-0 |