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ANAlyzeR ANA, IFA with Reflex Titer/Pattern, Systemic Autoimmune Panel 1

This test is used to evaluate patients with suspected autoimmune rheumatic disease.

Test Summary

ANAlyzeR™ ANA, IFA With Reflex Titer/Pattern, Systemic Autoimmune Panel 1

Test code: 36378

Clinical use

Evaluate suspected systemic autoimmune rheumatic diseases (SARDs) and related autoimmune disease

Clinical background

SARDs are a group of related conditions in which the immune system attacks the joints, muscles, and connective tissue. Many distinct SARDs have been identified, but some of the most common include

Rheumatoid arthritis (RA)
Systemic sclerosis (SSc)
Sjögren syndrome (SS)
Systemic lupus erythematosus (SLE)
Idiopathic inflammatory myopathies (IIM)
Mixed connective tissue disease (MCTD)

SARDs are often difficult to diagnose because their symptoms can be vague, vary from patient to patient, and often overlap.¹ They may also co-occur with other autoimmune diseases, such as autoimmune thyroid disease (ATD)² or antiphospholipid syndrome (APS).³ Diagnosis is based on clinical information, presentation, and laboratory test results. Although no single test can point to a definitive diagnosis for any one SARD, testing for autoantibodies—a hallmark of SARDs—is often one of the first steps in establishing a diagnosis.^1,4

Many autoantibodies are present in patients with SARDs, and many SARDs have distinct autoantibody profiles. Consequently, panels that simultaneously test for the presence or absence of numerous antibodies can efficiently help rule in or out specific conditions. To aid in differential diagnosis, individual autoantibodies specific for particular SARDs are included in testing approaches. In addition, antinuclear antibody (ANA) testing is typically performed. ANAs are present in most SARDs as well as several other autoimmune disorders.

ANA testing

ANAs are antibodies directed against a variety of nuclear antigens, and ANA testing may also detect other autoantibodies directed at cytoplasmic antigens. ANA screening is often the first test for suspected SARDs with 2 approaches commonly employed.⁴ The traditional approach uses fixed cells (typically human epithelial cells called HEp-2) and indirect immunofluorescence assay (IFA). Another approach is screening with a combination of individual antigen tests using immunoassay. International guidelines support the use of IFA as the primary approach but have stated that correlating the results of IFA with individual antigen screening adds value to the interpretation of both assays.⁵ Many studies support the value of combining the IFA with individual antibody screening (reviewed in reference 6). When combined, the 2 approaches can significantly improve sensitivity and specificity over each alone for detecting SARDs.⁷

The diagnostic value of ANA testing varies by condition. For example, ANA is present in most patients with MCTD, SLE, and SSc but may or may not be found in patients with SS or RA. Thus, a positive ANA result alone is not sufficient for diagnosis and a negative result cannot definitively rule out certain conditions.⁸ Similarly, many of the antibodies detected by IFA have limited or unknown clinical significance. A positive ANA result may be present in a variety of nonautoimmune disorders as well as in healthy individuals.^8-10 These results are usually of low titer, and screening using a titer of 1:80 helps to increase specificity (eg, SLE).¹¹

Specific antibody testing

A positive IFA for ANA is sensitive but not specific for SARDs. Staining patterns obtained during IFA can inform the differential diagnosis because certain patterns tend to be associated with certain diseases and autoantibodies,¹⁰ although most are not specific for those diseases. Consequently, testing is important for individual autoantibodies associated with a positive ANA, such as anti-dsDNA, Sm, RNP, etc.

RA is the most prevalent SARD and is less commonly associated with a positive ANA than the others. Autoantibodies associated with RA often target cyclic citrullinated peptide (CCP) and rheumatoid factor (RF). However, patients with RA may be negative for both of these autoantibodies, especially early in the onset of disease. Mutated citrullinated vimentin (MCV) autoantibody testing can be used to improve the sensitivity of early RA screening by 6% to 16%.¹²

APS is a rare but important disorder associated with SARD (primarily SLE), a positive ANA result, and 3 classes of antibody targeting 2 major antigens: cardiolipin and beta-2-glycoprotein 1.¹³

ATDs and their associated thyroid peroxidase (TPO) antibodies are relatively common in SARDs, including SLE, SSc, SS, and RA.^2,14-16 TPO antibodies are prevalent both in Hashimoto disease (autoimmune hypothyroidism) and Graves disease (autoimmune hyperthyroidism).^16,17 See Thyroid Dysfunction in Nonpregnant Adults | Clinical Focus | Quest Diagnostics for more information.

The ANAlyzeR^TM ANA, IFA With Reflex Titer/Pattern, Systemic Autoimmune Panel 1 simultaneously tests for ANA and 24 specific biomarkers associated with rheumatic and related diseases (Table 1) even if the IFA is negative. By concurrently performing immunoassays with ANA IFA, the panel casts a broad net for identifying most SARDs and compensates for the lack of specificity of IFA screening alone. Positive results for IFA reflex to titer and pattern; positive results for dsDNA also reflex to titer. Individual components can also be ordered separately. The relative importance of condition-specific antibodies is variable, ranging from inclusion in the diagnostic or classification criteria for each condition (Table 2) to a less specific association with the SARD. Notably, 2 tests in the ANAlyzeR panel are not antibodies: complement activation, indicated by serum levels of complement components C3 and C4, plays an important role in autoimmune diseases, especially SARDs.

Table 1. Component Tests of ANAlyzeR ANA, IFA With Reflex Titer/Pattern, Systemic Autoimmune Panel 1^a

Test code	Test name
249	ANA Screen, IFA, With Reflex to Titer and Pattern^b,c
36552	Beta-2-Glycoprotein I Antibody (IgA)
36554	Beta-2-Glycoprotein I Antibody (IgG)
36553	Beta-2-Glycoprotein I Antibody (IgM)
4661	Cardiolipin Antibody (IgA)
4662	Cardiolipin Antibody (IgG)
4663	Cardiolipin Antibody (IgM)
16088	Centromere B Antibody
34088	Chromatin (Nucleosomal) Antibody
351	Complement Component C3c
353	Complement Component C4c
11173	Cyclic Citrullinated Peptide (CCP) Antibody (IgG)
37092	DNA (ds) Antibody, Crithidia IFA With Reflex to Titer^b,d
5810	Jo-1 Antibody
13238	Mutated Citrullinated Vimentin (MCV) Antibody
19705	Rheumatoid Factor (IgA, IgG, IgM)
19887	RNP Antibody
4942	Scleroderma Antibody (Scl-70)
38568	Sjogren's Antibody (SS-A)
38569	Sjogren's Antibody (SS-B)
37923	Sm Antibody
38567	Sm/RNP Antibody
5081	Thyroid Peroxidase Antibodies (TPO)

a	Panel components can be ordered separately except as noted.
b	Reflex tests are performed at additional charge and are associated with an additional CPT code(s).
c	ANA titer and pattern cannot be ordered separately.
d	dsDNA titer and pattern cannot be ordered separately.

Table 2. Antibody Prevalence in Rheumatic and Related Diseases and Healthy Individuals,^a %

Analyte	SLE^18,19	MCTD²⁰	SSc²¹	SS²²	IIM²³	APS¹³	ATD	RA²⁴		HI
Analyte	SLE^18,19	MCTD²⁰	SSc²¹	SS²²	IIM²³	APS¹³	ATD	Early^b	All	HI
ANA^8,9,25	90-95	90-100	85-95^c	50-60	50-60	40-70	10-20	20	38	20-30
B2GP^13,26-28	7-22		7	5		78^d				5
C3 and C4 Complement²⁹	73^e
Cardiolipin^3,20,26-28	7-21	15	10-14	4		81^d				1
CCP^12,30,31	1		3	1				62	71	1
CENP-B⁹	2-5	2-5	20-40^c,f	5-10	1-3					<3
Chromatin⁹	40-70	5-18	<3	<3	<3					<3
dsDNA⁹	40-70	<3	<3	<3	<3					<3
Jo-1⁹	1-3	<2^g	1-3	<2	15-30					<1
MCV^12,31,32	12-36		10	10		27		78	71	≤5
RF^12,30,31,33	15-35	50-60	20-30	75-95	20			72	77	5-25
RNP⁹	10-40	100	5-15	<3	5-15					<3
Scl-70⁹	0-5	<3^h	20-40^f	<3	<3					<1
Sm⁹	5-20	<2	<2	<1	<1					<1
Sm/RNP^34,35	30	100	4	9	5
SS-A/Ro⁹	40-70	<3	3-10	60-90	<3					<3
SS-B/La⁹	15-30	<3	1-5	60-80	5-15					<3
TPO^2,14-16	4-28		5-21	10-18			>90ⁱ		38

ANA, antinuclear antibody; APS, antiphospholipid syndrome; ATD, autoimmune thyroid disease (ie, Graves disease or Hashimoto thyroiditis); B2GP1, beta-2-glycoprotein 1; CCP, cyclic citrullinated peptide; CENP-B, centromere B; dsDNA, double-stranded DNA; HI, healthy individuals; IIM, idiopathic inflammatory myopathies; Jo-1, histidyl-tRNA synthetase; MCTD, mixed connective tissue disease; MCV, mutated citrullinated vimentin; RA, rheumatoid arthritis; RF, rheumatoid factor; RNP, ribonucleoprotein; Scl-70, scleroderma-70 (topoisomerase 1); SLE, systemic lupus erythematosus; Sm, Smith; Sm/RNP, Smith/ribonucleoprotein; SS, Sjögren syndrome; SS-A, SS-B, Sjögren antibodies A and B; SSc, systemic sclerosis; TPO, thyroid peroxidase.
a	Highlighted antibodies represent classification or diagnostic criteria for the disease. Note that antibodies included in criteria are not always those with the highest prevalence in that disease.
b	Early RA defined as disease history of <1 year.
c	CREST syndrome is a variant of systemic sclerosis defined by the presence of calcinosis cutis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia. Also known as limited cutaneous scleroderma, CREST syndrome is characterized by the presence of ANA in 70% of patients, and CENP-B is present in 90% to 95%.³⁰
d	IgG type; 49% for cardiolipin IgM and 40% for B2GP IgM.²⁸
e	Low levels of both C3 and C4 are required for the prevalence of 73% of patients with SLE.²⁹
f	The presence of scleroderma-related antibodies (centromere, Scl-70, or RNA polymerase III antibodies) is not necessary or sufficient for diagnosis, but is useful for classification in the absence of diagnostic clinical findings (ie, “skin thickening of the fingers extending proximal to the metacarpophalangeal joints”²¹).
g	Especially in patients with features of muscle inflammation.
h	Especially in patients with features of systemic sclerosis.
i	Hashimoto thyroiditis.

Individuals suitable for testing

Individuals with signs and symptoms associated with autoimmune disease(s)

Methods

ANA screening performed with IFA using HEp-2 cells; positive ANA IFA results at a dilution of 1:80 prompt reflex to
Reporting of the corresponding antibody fluorescence pattern
Titer, determined by serial dilution until the pattern cannot be observed or to a dilution of 1:1,280
Immunoassay performed for B2GP (IgA, IgG, and IgM), cardiolipin (IgA, IgG, and IgM), CCP, centromere B, chromatin, Jo-1, MCV, RF (IgA, IgG, IgM), RNP, Scl-70, SS-A, SS-B, Sm, Sm/RNP, and TPO antibody testing
C3 and C4 complement testing performed by immunoturbidity
dsDNA antibody testing performed by indirect immunofluorescence (Crithidia luciliae substrate assay) with reflex to titer if positive

Interpretive information

A positive ANA IFA result (ie, a titer of >1:80) supports the presence of an autoimmune disease, especially in conjunction with a pattern associated with a specific SARD and/or a positive result (ie, “antibody detected” or levels/titers above reference range[s]) for disease-specific autoantibody (Table 1).

A negative or low-titer (1:80) ANA IFA result may indicate the absence of an autoimmune disease, unless there is a strong clinical suspicion and/or a positive result for a disease-specific autoantibody.

Low levels of C3 and/or C4 (ie, below patient age- and sex-specific reference ranges) indicate systemic inflammation.

References

Bizzaro N. Autoantibody profiles in autoimmune rheumatic diseases. Mediterr J Rheumatol. 2019;30(2):86-89. doi:10.31138/mjr.30.2.86
Franco J-S, Amaya-Amaya J, Anaya J-M. Thyroid disease and autoimmune diseases. In: Anaya JM, Shoenfeld Y, Rojas-Villarraga A, eds. Autoimmunity: from bench to bedside. El Rosario University Press; 2013:chap 3.
Marchetti T, Ribi C, Perneger T, et al. Prevalence, persistence and clinical correlations of classic and novel antiphospholipid antibodies in systemic lupus erythematosus. Rheumatology (Oxford). 2018;57(8):1350-1357. doi:10.1093/rheumatology/key095
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. doi:10.1136/annrheumdis-2013-203863
Bonroy C, Vercammen M, Fierz W, et al. Detection of antinuclear antibodies: recommendations from EFLM, EASI and ICAP. Clin Chem Lab Med. 2023;61(7):1167-1198. doi:10.1515/cclm-2023-0209
Fritzler MJ, Choi MY. Antinuclear antibody testing: gold standard revisited. J Appl Lab Med. 2022;7(1):357-361. doi:10.1093/jalm/jfab129
Bizzaro N, Brusca I, Previtali G, et al. The association of solid-phase assays to immunofluorescence increases the diagnostic accuracy for ANA screening in patients with autoimmune rheumatic diseases. Autoimmun Rev. 2018;17(6):541-547. doi:10.1016/j.autrev.2017.12.007
Kavanaugh A, Tomar R, Reveille J, et al. Guidelines for clinical use of the antinuclear antibody test and tests for specific autoantibodies to nuclear antigens. American College of Pathologists. Arch Pathol Lab Med. 2000;124(1):71-81. doi:10.5858/2000-124-0071-GFCUOT
Mahler M, Meroni PL, Bossuyt X, et al. Current concepts and future directions for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. J Immunol Res. 2014;2014:315179. doi:10.1155/2014/315179
Bossuyt X, De Langhe E, Borghi MO, et al. Understanding and interpreting antinuclear antibody tests in systemic rheumatic diseases. Nat Rev Rheumatol. 2020;16(12):715-726. doi:10.1038/s41584-020-00522-w
Leuchten N, Hoyer A, Brinks R, et al. Performance of antinuclear antibodies for classifying systemic lupus erythematosus: a systematic literature review and meta-regression of diagnostic data. Arthritis Care Res. 2018;70(3):428-438. doi:10.1002/acr.23292
Liu X, Jia R, Zhao J, et al. The role of anti-mutated citrullinated vimentin antibodies in the diagnosis of early rheumatoid arthritis. J Rheumatol. 2009;36(6):1136-1142. doi:10.3899/jrheum.080796
Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006;4(2):295-306. doi:10.1111/j.1538-7836.2006.01753.x
Posselt RT, Coelho VN, Pigozzo DC, et al. Prevalence of thyroid autoantibodies in patients with systematic autoimmune rheumatic diseases: cross-sectional study. Sao Paulo Med J. 2017;135(6):535-540. doi:10.1590/1516-3180.2017.0089110617
Koszarny A, Majdan M, Dryglewska M, et al. Prevalence of selected organ-specific autoantibodies in rheumatoid arthritis and primary Sjögren's syndrome patients. Reumatologia. 2015;53(2):61-68. doi:10.5114/reum.2015.51504
Lazarus JH. Chronic (Hashimoto's) thyroiditis. In: Jameson JL, De Groot LJ, eds. Endocrinology. 6th ed. Saunders Elsevier; 2010:1583-1594:chap 83.
Marinò M, Chiovato L, Pinchera A. Graves' Disease. In: Jameson JL, De Groot LJ, eds. Endocrinology. 6th ed. Saunders Elsevier; 2010:1527-1558:chap 80.
Petri M, Orbai AM, Alarcón GS, et al. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012;64(8):2677-2686. doi:10.1002/art.34473
Aringer M, Costenbader K, Daikh D, et al. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Ann Rheum Dis. 2019;78(9):1151-1159. doi:10.1136/annrheumdis-2018-214819
Ortega-Hernandez OD, Shoenfeld Y. Mixed connective tissue disease: an overview of clinical manifestations, diagnosis and treatment. Best Pract Res Clin Rheumatol. 2012;26(1):61-72. doi:10.1016/j.berh.2012.01.009
van den Hoogen F, Khanna D, Fransen J, et al. 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League against Rheumatism collaborative initiative. Arthritis Rheum. 2013;65(11):2737-2747. doi:10.1002/art.38098
Shiboski CH, Shiboski SC, Seror R, et al. 2016 American College of Rheumatology/European League Against Rheumatism classification criteria for primary Sjögren's syndrome: a consensus and data-driven methodology involving three international patient cohorts. Ann Rheum Dis. 2017;76(1):9-16. doi:10.1136/annrheumdis-2016-210571
Lundberg IE, Tjärnlund A, Bottai M, et al. 2017 European League Against Rheumatism/American College of Rheumatology classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups. Ann Rheum Dis. 2017;76(12):1955-1964. doi:10.1136/annrheumdis-2017-211468
Aletaha D, Neogi T, Silman AJ, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569-2581. doi:10.1002/art.27584
Rönnelid J, Turesson C, Kastbom A. Autoantibodies in rheumatoid arthritis - laboratory and clinical perspectives. Front Immunol. 2021;12:685312. doi:10.3389/fimmu.2021.685312
Morrisroe KB, Stevens W, Nandurkar H, et al. The association of antiphospholipid antibodies with cardiopulmonary manifestations of systemic sclerosis. Clin Exp Rheumatol. 2014;32(6) (suppl 86):S133-S137.
Pasoto SG, Chakkour HP, Natalino RR, et al. Lupus anticoagulant: a marker for stroke and venous thrombosis in primary Sjögren's syndrome. Clin Rheumatol. 2012;31(9):1331-1338. doi:10.1007/s10067-012-2019-z
Rodríguez-Pintó I, Moitinho M, Santacreu I, et al. Catastrophic antiphospholipid syndrome (CAPS): descriptive analysis of 500 patients from the International CAPS Registry. Autoimmun Rev. 2016;15(12):1120-1124. doi:10.1016/j.autrev.2016.09.010
Li H, Lin S, Yang S, et al. Diagnostic value of serum complement C3 and C4 levels in Chinese patients with systemic lupus erythematosus. Clin Rheumatol. 2015;34(3):471-477. doi:10.1007/s10067-014-2843-4
van Paassen P, Damoiseaux J, Tervaert JWC. Laboratory assessment in musculoskeletal disorders. Best Pract Res Clin Rheumatol. 2003;17(3):475-494. doi:10.1016/s1521-6942(03)00029-9
Zhu JN, Nie LY, Lu XY, et al. Meta-analysis: compared with anti-CCP and rheumatoid factor, could anti-MCV be the next biomarker in the rheumatoid arthritis classification criteria? Clin Chem Lab Med. 2019;57(11):1668-1679. doi:10.1515/cclm-2019-0167
Alessandri C, Agmon-Levin N, Conti F, et al. Anti-mutated citrullinated vimentin antibodies in antiphospholipid syndrome: diagnostic value and relationship with clinical features. Immunol Res. 2017;65(2):524-531. doi:10.1007/s12026-017-8899-x
Ingegnoli F, Castelli R, Gualtierotti R. Rheumatoid factors: clinical applications. Dis Markers. 2013;35(6):727-734. doi:10.1155/2013/726598
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Satoh M, Vázquez-Del Mercado M, Chan EK. Clinical interpretation of antinuclear antibody tests in systemic rheumatic diseases. Mod Rheumatol. 2009;19(3):219-228. doi:10.1007/s10165-009-0155-3

Content reviewed 6/2026

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Related tests (24)

5810 - Jo-1 Antibody

Jo-1 Antibody occurs most frequently (31%) in patients with polymyositis, but has also been found in patients with dermatomyositis, and the polymyositis/scleroderma "overlap syndrome" (PM/SCL) or polymyositis/systemic lupus erythematosis "overlap syndrome" (PM/SLE).

4942 - Scleroderma Antibody (Scl-70)

Scl-70 antibody is present in approximately 40% of patients with progressive systemic sclerosis (PSS).

13238 - Mutated Citrullinated Vimentin (MCV) Antibody

Anti-mutated citrullinated vimentin (MCV) antibody is one of several specific anti-citrullinated protein antibodies which may be used as a second-line marker of rheumatoid arthritis (RA), in addition to rheumatoid factor and anti-cyclic citrullinated peptide (CCP). MCV antibody is less specific than CCP but has a slightly higher sensitivity and the addition of MCV to CCP adds 5-10% sensitivity for the diagnosis of RA. MCV antibody positivity is also associated with more severe disease and greater radiologic progression.

38567 - Sm/RNP Antibody

Smith (Sm)/U1-RNP Antibody is detected in patients with mixed connective tissue disease (having features of systemic lupus erythematosus (SLE), scleroderma, and polymyositis).

351 - Complement Component C3c

Decreased C3 may be associated with acute glomerulonephritis, membranoproliferative glomerulonephritis, immune complex disease, active systemic lupus erythematosis, and generalized autoimmune processes.

38569 - Sjogren's Antibody (SS-B)

Sjögren's Antibody (SS-B) is detected in approximately 15% of patients with Sjögren's Syndrome. Sjögren's Antibody (SS-B) is present only if Sjögren's Antibody (SS-A) is also detected. The presence of both antibodies (SS-A and SS-B) strengthen the diagnosis of Sjögren's Syndrome and conveys prognostic information.

4661 - Cardiolipin Antibody (IgA)

Cardiolipin antibodies (CA) are seen in a subgroup of patients with autoimmune disorders, particularly Systemic Lupus Erythematosus (SLE), who are at risk for vascular thrombosis, thrombocytopenia, cerebral infarct and/or recurrent spontaneous abortion. Elevations of CA associated with increased risk have also been seen in idiopathic thrombocytopenic purpura, rheumatoid and psoriatic arthritis, and primary Sjögren's syndrome.

36552 - Beta-2-Glycoprotein I Antibody (IgA)

Beta-2-Glycoprotein 1, apolipoprotein H, is a cofactor in antiphospholipid antibody binding and is the critical antigen in the antiphospholipid antibody syndrome. Beta-2- Glycoprotein 1 antibody is more specific than cardiolipin antibody that may express reactivity in patients with syphilis and other infectious diseases.

19887 - RNP Antibody

RNP Antibodies have been associated with Mixed Connective Tissue disease.

36378 - ANAlyzeR™ ANA, IFA with Reflex Titer/Pattern, Systemic Autoimmune Panel 1

This panel can be helpful in the diagnosis of systemic rheumatic disorders and other autoimmune diseases. Although the test for antinuclear antibodies (ANA) is strongly associated with systemic lupus erythematosus (SLE), the laboratory evaluation for individuals with clinical suspicion of a variety of autoimmune diseases often begins with an ANA screen. This panel simultaneously tests for ANA (using immunofluorescence) as well as the important specific autoantibodies associated with a positive ANA. It also includes testing for complement proteins, rheumatoid arthritis, Sjogren's syndrome, systemic sclerosis, polymyositis, anti-phospholipid antibody syndrome, and autoimmune thyroid disease.

37923 - Sm Antibody

Smith Antibody (Sm) is highly specific for systemic lupus erythematosus (SLE). Smith Antibody is also detected in approximately 15% of patients with SLE. Smith Antibody is detected in more than half of young African-American women with SLE.

5081 - Thyroid Peroxidase Antibodies (TPO)

Assists in the diagnosis of thyroid diseases such as endemic goiter, Graves Disease, autoimmune thyroiditis, Addison's Disease, insulin-dependent diabetes mellitus, Hashimoto's Disease and polyendocrine auto-immunopathies.

11173 - Cyclic Citrullinated Peptide (CCP) Antibody (IgG)

A synthetic circular peptide containing citrulline called CCP IgG (cyclic citrullinated peptide) has been found to be better at discriminating Rheumatoid Arthritis patients from patients with other diseases such as hepatitis C infection. Rheumatoid Arthritis Classification Criteria include CCP IgG Antibody, rheumatoid factor, C-reactive protein and erythrocyte sedimentation rate (ESR). Approximately 70% of patients with Rheumatoid Arthritis are positive for Anti-CCP IgG, while only about 2% of random blood donors and disease controls subjects are positive.

37092 - DNA (ds) Antibody, Crithidia IFA with Reflex to Titer

dsDNA Antibody is detected in patients with active systemic lupus erythematosus (SLE) and approximately 20% of patients with mixed connective tissue disease.

36553 - Beta-2-Glycoprotein I Antibody (IgM)

16088 - Centromere B Antibody

Centromere B Antibody is diagnostic for the form of scleroderma known as CREST (calcinosis, Raynaud's phenomenon, esophageal immotility, sclerodactyly, and telangiectasia).

19705 - Rheumatoid Factor (IgA, IgG, IgM)

The concentration of RF tends to be highest when the disease peaks and tends to decrease during prolonged remission. RF IgM is found in 1 to 4% of the general population. RF is present in 75% of adult RA patients with the highest incidence of RF occurring in persons over 65 years of age. Increased RF levels may also accompany a variety of acute immune responses, particularly viral infections and a number of liver diseases (infectious mononucleosis, tuberculosis, leprosy, various parasitic diseases, liver disease, sarcoidosis, and systemic lupus erythematosus).

In addition to RF IgM, raised levels of RF IgA and IgG have been reported in patients with RA. Studies from as early as 1984 suggest that the detection of RF IgA in early disease indicates poor prognosis and justifies a more aggressive course of treatment. Recently, it has become apparent that the specificity and predictive value of the RF test is substantially increased by the detection of all three RF isotypes.

4663 - Cardiolipin Antibody (IgM)

249 - ANA Screen,IFA, with Reflex to Titer and Pattern

This immunofluorescence assay (IFA) is often ordered as part of an initial diagnostic evaluation of individuals with clinical suspicion of autoimmune diseases associated with antinuclear antibodies (ANAs). The American College of Rheumatology (ACR) recommends IFA on human epithelial type 2 (HEp-2) cells as the gold standard method for ANA testing because of its overall high sensitivity [1].

ANAs are associated with several autoimmune diseases, such as systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis, primary biliary cholangitis, rheumatoid arthritis, juvenile rheumatoid arthritis, Sjogren syndrome, and autoimmune hepatitis. The laboratory evaluation for individuals with clinical suspicion of these autoimmune diseases often begins with an ANA screen.

Knowing the ANA titer can be helpful in interpreting positive ANA results. A titer of at least 1:40 is considered positive, but low-positive titers are not uncommon in healthy individuals. Higher titers are generally associated with greater likelihood of autoimmune disease [2]. When results are positive, various fluorescent staining patterns observed in the nucleus or the cytoplasm can aid in the differential diagnosis and guide selection of further testing for specific autoantibodies. The International Consensus on Antinuclear Antibody Pattern provides guidance on interpretation and reporting of IFA staining patterns with HEp-2 cells [3].

Individuals with negative results on the ANA IFA usually also have negative results on specific ANAs. Therefore, subserology testing is generally not recommended in individuals without positive ANA IFA results and clinical suspicion of relevant autoimmune disease [4]. However, Jo-1 antibody may be detected in ANA IFA-negative patients with some types of myositis, and SSA antibody may be detected in some ANA IFA-negative patients with lupus or Sjogren syndrome [4].

The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings.

References
1. Methodology of testing for antinuclear antibodies (position statement). 2009. American College of Rheumatology. Updated December 2019. Accessed May 15, 2023. https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/blta48818378bc89445/acr-position-statement-methodology-testing-antinuclear-antibodies.pdf
2. Tozzoli R, et al. Am J Clin Pathol. 2002;117(2):316-324.
3. Chan EK, et al. Front Immunol. 2015;6:412.
4. Yazdany J, et al. Arthritis Care Res (Hoboken). 2013;65(3):329-339.

4662 - Cardiolipin Antibody (IgG)

38568 - Sjogren's Antibody (SS-A)

Sjögren's Antibodies (SS-B) is detected in approximately 15% of patients with Sjögren's Syndrome. Sjögren's Antibody (SS-B) is present only if Sjögren's Antibody (SS-A) is also detected. The presence of both antibodies (SS-A and SS-B) strengthen the diagnosis of Sjögren's Syndrome and conveys prognostic information.

34088 - Chromatin (Nucleosomal) Antibody

Chromatin Antibody plays a central role in the autoimmune response in systemic lupus erythematosus (SLE). Approximately 90% of patients with SLE have sera that will exhibit reactivity to nucleosomes.

353 - Complement Component C4c

Decreased C4 level is associated with acute systemic lupus erythematosis, glomerulonephritis, immune complex disease, cryoglobulinemia, congenital C4 deficiency and generalized autoimmune disease.

36554 - Beta-2-Glycoprotein I Antibody (IgG)

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Systemic Sclerosis: Laboratory Markers for Diagnosis and Prognosis

This Clinical Focus provides information about autoantibody testing related to systemic sclerosis.

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Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

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