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Autoimmune Diseases: Use of Antinuclear and Specific Antibodies for Diagnosis

Autoimmune Diseases: Use of Antinuclear and Specific Antibodies for Diagnosis

Test Guide

Autoimmune Diseases

Use of Antinuclear and Specific Antibodies for Diagnosis

 

Autoimmune diseases are difficult to diagnose; their symptoms can be vague, vary from patient to patient, and often overlap. Moreover, there is no single diagnostic test for any one autoimmune disease. Diagnosis is most often based on a compilation of clinical information, family history, data from laboratory testing, and, in some cases, imaging tests. Laboratory tests include relatively nonspecific antinuclear antibody (ANA) testing and/or tests for individual antibodies that are more disease specific.

Antinuclear antibody is a marker of inflammation and autoimmune processes and, as such, is a general marker of autoimmune disease. Therefore, it is a good first test for suspected autoimmune disease. Several methods of ANA testing are available, including immunofluorescence assay (IFA), enzyme-linked immunosorbent assay (ELISA), and multiplex immunobead assay. The American College of Rheumatology (ACR) recommends using an IFA with HEp-2 cells, because the test is highly sensitive.1 This sensitivity stems from the number of autoantigens (up to 150) in the HEp-2 cells. The nuclear and cytoplasmic fluorescence patterns suggest certain types of autoimmune disease.2,3 Although these patterns are not specific for a particular disease type, the information may aid diagnosis. A positive ANA result does not necessarily indicate presence of an autoimmune disease. Healthy individuals, particularly as they age, and those with certain infectious diseases or cancer, may have positive results.4 Therefore, ANA test results must be reviewed in the proper clinical context.

Immunoassay-based specific antibody tests are less sensitive than ANA IFA for antinuclear and anticytoplasmic autoantibody screening; however, they are often more specific for a particular autoimmune disease than is ANA IFA.5,6 Therefore, they can be used to aid in differential diagnosis.

There is no single best way to approach laboratory testing for autoimmune disease; the approach depends on the clinical picture. Three different screening approaches are discussed here.

First Approach: Screen for Suspected Autoimmune Disease

The first approach begins with ANA screening alone (ANA Screen, IFA, with Reflex to Titer and Pattern, test code 249) and may be considered as part of an evaluation for possible autoimmune disease (Figure). A positive ANA result in conjunction with clinical suspicion suggests that autoimmune disease is likely. The diagnostic value of a positive ANA result depends on the condition (Table 1). A negative ANA result suggests the absence of many autoimmune diseases, but does not rule them out. Additional testing, for example with specific antibody tests, should be considered if clinically warranted (Table 2).

Figure. Screening and Diagnosis of Patients With Suspected Autoimmune or Rheumatic Disease or Rheumatoid Arthritis

Table 1. Diagnostic Value of an Antinuclear Antibody Test7,8

Value of Positive ANA

Condition

Comments/Recommendationsa

Critical

Drug-associated lupus

  • Positive ANA part of the diagnostic criteria
  • ANA useful for symptomatic people who are taking a drug associated with drug-induced lupus

Mixed connective tissue disease (MCTD)

  • Positive ANA part of the diagnostic criteria
  • ANA recommended when clinical suspicion of MCTD
  • Follow-up with RNP antibody recommended to confirm diagnosis

Autoimmune hepatitis

  • Positive ANA part of diagnostic criteria
  • Positive ANA often seen in patients with diverse liver disease; does not exclude other hepatic diseases

Very useful

Systemic lupus erythematosus (SLE)

  • ANA sensitivity 93%, specificity 57%
  • Best initial test when clinical suspicion of SLE is strong
  • SLE unlikely if ANA negative
  • Specific antibody tests recommended as follow-up to positive ANA

Systemic sclerosis (SSc)

  • ANA sensitivity 85%, specificity 54%
  • ANA recommended when clinical suspicion of SSc
  • If negative, consider other fibrosing illnesses (eg, eosinophilic fasciitis, linear scleroderma)

May be useful

Sjögren syndrome

  • ANA sensitivity 48%, specificity 52%
  • Not useful for diagnosis
  • Can help clarify whether an underlying connective tissue disease exists when Sjögren syndrome suspected to be related to SLE

Polymyositis/ dermatomyositis

  • ANA sensitivity 61%, specificity 63%
  • Positive result provides only weak evidence of disease even when combined with clinical suspicion
  • Must consider other connective tissue diseases (SLE or overlap syndrome) regardless of ANA status

ANA, antinuclear antibody test; RNP, ribonucleoprotein.

a

The American College of Rheumatology Ad Hoc Committee on Immunologic Testing Guidelines7

Table 2. Tests to Consider When Antinuclear Antibody Is Negativea

Test Code

Test Name

Ankylosing Spondylitis

528

HLA-B27 Antigen

Autoimmune Thyroid Disease

36574

T3 (Triiodothyronine) Antibodyb

36576

T4 (Thyroxine) Antibodyb

267

Thyroglobulin Antibodies

7260

Thyroid Peroxidase and Thyroglobulin Antibodies (Panel components may be ordered separately.)

Includes thyroid peroxidase (5081) and thyroglobulin (267) antibodies.

5081

Thyroid Peroxidase Antibodies

36577

TSH Antibodyb

30551

TSI (Thyroid Stimulating Immunoglobulin)

Celiac Disease

19955

Celiac Disease Comprehensive Panel (Panel components may be ordered separately.)

Includes tissue transglutaminase antibody (IgA) (8821) with reflex(es) to endomysial antibody screen (IgA) with reflex to titer (15064); also includes serum IgA (539) with reflex to tissue transglutaminase antibody (IgG) (11070).

Gout/Pseudogout

4563

Crystals, Synovial Fluid

905

Uric Acid

Inflammatory Bowel Disease

70171(X)

ANCA Screen with Reflex to ANCA Titer

Includes ANCA screen with reflex to C-ANCA, P-ANCA and/or atypical P-ANCA titer.

16503(X)

Inflammatory Bowel Disease Differentiation Panel (Panel components may be ordered separately.)

Includes ANCA screen with reflex to P-ANCA, C-ANCA, and atypical P-ANCA titers (70171X); also includes myeloperoxidase antibody (8796), proteinase-3 antibody (34151), and Saccharomyces cerevisiae IgG and IgA (17609).

17609

Saccharomyces cerevisiae Antibodies (ASCA) (IgA, IgG)

Multiple Sclerosis

17728(X)

Multiple Sclerosis Panel (Panel components may be ordered separately.)

Includes oligoclonal bands (IgG) (674) and myelin basic protein in CSF (663).

37581(X)

Multiple Sclerosis Panel 1 (Panel components may be ordered separately.)

Includes oligoclonal bands (IgG) (674) and IgG synthesis rate/index on CSF (7558X).

7085(X)

Multiple Sclerosis Panel 2b (Panel components may be ordered separately.)

Includes oligoclonal bands (IgG) (674), IgG synthesis rate/index on CSF (7558X), and myelin basic protein In CSF (663).

Myasthenia Gravis

10104

Myasthenia Gravis Panelb (Panel components may be ordered separately.)

Includes acetylcholine receptor binding (206), blocking (34459), and modulating (26474) antibodies.

7550(X)

Myasthenia Gravis Panel 1c (Panel components may be ordered separately.)

Includes acetylcholine receptor binding antibody (206) and striated muscle antibody screen with reflex to titer (266).

10211(X)

Myasthenia Gravis Panel 3c (Panel components may be ordered separately.)

Includes acetylcholine receptor binding (206), blocking (34459), and modulating (26474) antibodies and striated muscle antibody screen with reflex to titer (266).

Myositis/Polymyositis/Dermatomyositis

94025

Anti-PM/Scl Antibody (EIA)

TBDd

Idiopathic Inflammatory/Juvenile Myopathies Panel 2b (Some panel components may be ordered separately.)

Includes EJ, Jo-1 (5810), Ku (18855), Mi-2 (17172X), OJ, P140, P155/140, PL-7, PL-12, PM/Scl (94025), SS-A (38568), SRP (16318), U1-RNP, U2-RNP, and U3-RNP antibodies.

10185

Myositis AssessR™ plus Jo-1 Antibodies (Some panel components may be ordered separately.)

Includes EJ, Jo-1 (5810), Ku (18855), Mi-2 (17172X), OJ, PL-7, PL-12, and SRP (16318) antibodies.

Rheumatoid Arthritis

91472

Rheumatoid Arthritis Diagnostic IdentRA® Panel 2b (Panel components may be ordered separately.)

Includes 14-3-3 eta protein (91455), cyclic citrullinated peptide (CCP) IgG (11173), and rheumatoid factor (4418).

19878

Rheumatoid Arthritis Diagnostic Panel 3 (Panel components may be ordered separately.)

Includes cyclic citrullinated peptide (CCP) IgG (11173); rheumatoid factor IgG, IgA, and IgM (19705); SS-A (38568); and SS-B (38569) antibodies.

TBD

Rheumatoid Arthritis Diagnostic IdentRA® Panel 4 (Panel components may be ordered separately.)

Includes 14-3-3 eta protein (91455), cyclic citrullinated peptide (CCP) IgG (11173), rheumatoid factor antibodies (IgG, IgA, IgM) (19705), and SS-A (38568) and SS-B (38569) antibodies.

Sjögren Syndrome

93748

Early Sjögren Syndrome Profile

Includes carbonic anhydrase 6 IgG, IgM, IgA; parotid secretory protein IgG, IgM, IgA; and salivary gland protein (SP1) IgG, IgM, IgA.

7832

Sjögren Antibodies (SS-A, SS-B)

Vasculitis

36733

ANCA Vasculitides

Includes proteinase-3 and myeloperoxidase antibodies.

Viral Arthritis

6421

Epstein-Barr Virus Antibody Panel (Panel components may be ordered separately.)

Includes Epstein-Barr Virus VCA Antibody (IgM) (8426), Epstein-Barr Virus VCA Antibody (IgG) (8474), Epstein-Barr Virus Nuclear Antigen (EBNA) Antibody (IgG) (8564).

501

Hepatitis B Core Antibody, Total

499

Hepatitis B Surface Antibody, Qualitative

498

Hepatitis B Surface Antigen with Reflex to Confirmationa

8472

Hepatitis C Antibody with Reflex to HCV RNA, Quantitative Real-Time PCRa

8946

Parvovirus Antibodies (IgG, IgM)

37673

Rubella Antibodies (IgG, IgM) Diagnostic

ANCA, antineutrophil cytoplasmic antibodies; C-ANCA, cytoplasmic antineutrophil cytoplasmic antibodies; CSF, cerebrospinal fluid; EJ, glycyl tRNA synthetase; Jo-1, histidyl-tRNA synthetase; Ku, DNA protein kinase regulatory subunit; Mi-2, helicase protein; OJ, isoleucyl tRNA synthetase; P140, nuclear matrix protein-2; P155/140, transcriptional intermediary factor 1-γ; P-ANCA, perinuclear antineutrophil cytoplasmic antibodies; PL-7, threonyl-tRNA synthetase; PL-12, alanyl-tRNA synthetase; PM/Scl, polymyositis-scleroderma; RNP, ribonucleoprotein; SRP, signal recognition particle; SS-A, SS-B, Sjögren syndrome A and B; and TBD, to be determined.

a

Reflex tests are performed at an additional charge and are associated with an additional CPT code(s).

b

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

c

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

d

Available in 2017.

Second Approach: Screen for Suspected Autoimmune Rheumatic Disease

A second screening approach begins with ANA IFA with reflex to a rheumatic disease-associated antibody panel (ANA Screen, IFA, with Reflex to Titer and Pattern and Reflex to Multiplex 11-Antibody Cascade, test code 16814) (Figure). This option is appropriate when there is clinical suspicion of a rheumatic disease. Testing for multiple autoantibodies is usually required for differential diagnosis (Figure, Table 3).2,8,9 If the ANA IFA is positive, a positive result on one of the cascade tiers may suggest the presence of a certain autoimmune disease(s) (Figure, Table 3). If the ANA IFA is positive but the antibody cascade is negative, tests for other autoimmune diseases may be considered if clinically indicated (Table 4).

Table 3. Autoantibody Prevalence (%) in Rheumatic and Related Diseases7,10,11-22,a

Antibody

SLE

MCTD

Sjögren Syndrome

Systemic Sclerosis

Poly-myositis

CREST Syndromeb

Neurologic SLE

ANA

93

100

48

85

61

70

NA

Cen B

3-12

7c

<2

27

<2

66

 

Chromatin

37-73

˃80

12

14

8

 

 

dsDNA

57-62

0-8

11-20

8

10-43

 

 

Jo-1

<2

7d

<2

<2

17

 

 

Rib P

 

7

<2

<2

<2

 

9-30

RNP

22-48

˃80

12

14

8

 

 

Scl-70

2-3

7e

<2

16

<2

 

 

Sm

20-30

8

4

0

10

 

 

Sm/RNP

30

54-94

9

4

9

 

 

SS-A

33-52

13

˃80

23

42

 

 

SS-B

13-27

<2

˃80

5

<2

 

 

ANA, antinuclear antibody; Cen B, centromere B; dsDNA, double-stranded DNA; Jo-1, histidyl-tRNA synthetase; NA, not available; MCTD, mixed connective tissue disease; Rib P, ribosomal P; RNP, ribonucleoprotein; Scl-70, scleroderma (topoisomerase 1); SLE, systemic lupus erythematosus; Sm, Smith; Sm/RNP, Smith/ribonucleoprotein; and SS-A, SS-B, Sjögren antibodies A and B.

a

Highlighted antibodies represent diagnostic criteria for the disease. Note that antibodies whose presence is a diagnostic criterion do not always correspond to those with the highest prevalence in that disease.

b

CREST is a syndrome defined by presence of calcinosis cutis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia.

c

Typically in cases with features of polymyositis.

d

Especially in cases with features of muscle inflammation.

e

Especially in cases with features of systemic sclerosis.

Table 4. Tests to Consider When Antinuclear Antibody is Positive and Multiplex 11-Antibody Test is Negativea

Test Code

Test Name

Autoimmune Hepatitis

15043

Actin (Smooth Muscle) Antibody (IgG)

15038

Liver Kidney Microsome (LKM-1) Antibody (IgG)

259

Mitochondrial Antibody with Reflex to Titer

Bullous Pemphigoid

16034

Bullous Pemphigoid Antigen (BP180) Antibody

16136

Bullous Pemphigoid BP230 IgG

16033(X)

Desmoglein Antibodies (1 and 3)

Myositis/Polymyositis/Dermatomyositis

94025

Anti-PM/Scl Antibody (EIA)

TBDb

Idiopathic Inflammatory/Juvenile Myopathies Panel 2c (Some panel components may be ordered separately.)

Includes EJ, Jo-1 (5810), Ku (18855), Mi-2 (17172X), OJ, P140, P155/140, PL-7, PL-12, PM/Scl (94025), SS-A (38568), SRP (16318), U1-RNP, U2-RNP, and U3-RNP antibodies.

10185

Myositis AssessR™ plus Jo-1 Antibodies (Some panel components may be ordered separately.)

Includes EJ, Jo-1 (5810), Ku (18855), Mi-2 (17172X), OJ, PL-7, PL-12, and SRP (16318) antibodies.

Primary Biliary Cholangitis (Primary Biliary Cirrhosis)

15043

Actin (Smooth Muscle) Antibody (IgG)

15038

Liver Kidney Microsome (LKM-1) Antibody (IgG)

259

Mitochondrial Antibody with Reflex to Titer

5081

Thyroid Peroxidase Antibodies

Rheumatoid Arthritis

91455

14-3-3 eta Proteinc

11173

Cyclic Citrullinated Peptide (CCP) Antibody (IgG)

91472

Rheumatoid Arthritis Diagnostic IdentRA® Panel 2c (Panel components may be ordered separately.)

Includes 14-3-3 eta protein (91455), cyclic citrullinated peptide (CCP) IgG (11173), and rheumatoid factor (4418).

19878

Rheumatoid Arthritis Diagnostic Panel 3 (Panel components may be ordered separately.)

Includes cyclic citrullinated peptide (CCP) IgG (11173); rheumatoid factor IgG, IgA, and IgM (19705); SS-A (38568); and SS-B (38569) antibodies.

92812

Rheumatoid Arthritis Diagnostic IdentRA® Panel 4 (Panel components may be ordered separately.)

Includes 14-3-3 eta protein (91455), cyclic citrullinated peptide (CCP) IgG (11173), rheumatoid factor antibodies (IgG, IgA, IgM) (19705), and SS-A (38568) and SS-B (38569) antibodies.

4418

Rheumatoid Factor

19705(X)

Rheumatoid Factor (IgA, IgG, IgM)

Sjögren Syndrome

93748

Early Sjögren Syndrome Profile

Includes carbonic anhydrase 6 IgG, IgM, IgA; parotid secretory protein IgG, IgM, IgA; and salivary gland protein (SP1) IgG, IgM, IgA.

259

Mitochondrial Antibody with Reflex to Titer

4418

Rheumatoid Factor

5081

Thyroid Peroxidase Antibodies

Systemic Lupus Erythematosus

15043

Actin (Smooth Muscle) Antibody (IgG)

37859(X)

Complement Components C3, C4, and Total (CH50)

15114

Gastric Parietal Cell Antibody, ELISA

37056(X)

Histone Antibodies

259

Mitochondrial Antibody with Reflex to Titer

37520

Reticulin IgA Screen with Reflex to Titer

4418

Rheumatoid Factor

266

Striated Muscle Antibody with Reflex to Titer

5081

Thyroid Peroxidase Antibodies

Systemic Sclerosis

TBDb

Systemic Sclerosis Nucleolar Antibodies Panel 1c (Some panel components may be ordered separately.)

Includes Scl-70 (4942), centromere B (16088), RNA polymerase III subunit RP11, RNA polymerase III subunit RP155, PM-Scl100, PM-Scl75, U1-snRNP, U3-snRNP (fibrillarin), and Th/To antibodies.

ds, double-stranded; EJ, glycyl-tRNA synthetase; IFA, immunofluorescent assay; Jo-1, histidyl-tRNA synthetase; Ku, DNA protein kinase regulatory subunit; Mi-2, helicase protein; OJ, isoleucyl-tRNA synthetase; P140, nuclear matrix protein-2; P155/140, transcriptional intermediary factor 1-γ; PL-7, threonyl-tRNA synthetase; PL-12, alanyl-tRNA synthetase; PM/Scl, polymyositis-scleroderma; RNP, ribonucleoprotein; RP11, RNA polymerase III subunit 11; RP155, RNA polymerase subunit 155; Scl-70, scleroderma (topoisomerase I) antibody; snRNP, small nuclear ribonucloprotein; SRP, signal recognition particle; SS-A, SS-B, Sjögren syndrome A and B; and TBD, to be determined.

a

Reflex tests are performed at an additional charge and are associated with an additional CPT code(s)

b

Available in 2017.

c

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Third Approach: Screen for Specific Autoimmune Diseases Not Included in Multiplex 11-Antibody Panel (Test Code 16814)

A third option may be considered when the clinical picture suggests a specific autoimmune disorder not included in the rheumatic disease-associated antibody panel (test code 16814, Figure). In this case, testing can begin with an ANA IFA panel that reflexes to antibodies associated with the suspected disorder (Table 5). For instance, if rheumatoid arthritis is suspected, testing for rheumatoid factor and cyclic citrullinated peptide antibodies,23 as well as 14-3-3η protein,24 is appropriate (Figure). Positive ANA IFA and positive antibody test(s) results are consistent with the presence of the suspected disorder. If the ANA IFA is positive and the specific antibody test(s) are negative, selection of additional antibody tests will depend on the clinical picture.

Table 5. Tests That Include Antinuclear Antibody and Markers Associated With Other Autoimmune Diseasesa

Test Code

Test Name

Autoimmune Hepatitis

19873

Autoimmune Hepatitis Diagnostic Panel (Panel components may be ordered separately.)

Includes ANA screen (IFA) with reflex to ANA titer and pattern (249); also includes actin (smooth muscle) IgG (15043), liver kidney microsome (LKM-1) IgG (15038), and mitochondrial antibody screen with reflex to titer (259).

Connective Tissue Disease

10547(X)

ANA Multiplex with Reflex to dsDNA

Includes ANA multiplex test with reflex to dsDNA (255).

Drug-Induced Lupus

19874(X)

ANA Screen, IFA, with Reflex to Titer and Pattern (Lupus Drug Induced Panel 1) (Panel components may be ordered separately.)

Includes ANA screen (IFA) with reflex to titer and pattern (249); also includes histone antibody (37056).

Mixed Connective Tissue Disease

19875

ANA Screen, IFA, with Reflex to Titer and Pattern/Mixed Connective Panel 1 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); also includes RNP antibody (19887).

90074

ANA Screen, IFA, with Reflex to Titer and Pattern/Mixed Connective Panel 2 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); also includes dsDNA (255), RNP (19887), and Scl-70 (4942) antibodies.

Primary Biliary Cirrhosis

19876

Primary Biliary Cirrhosis Diagnostic Panel (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249), SS-A (38568), SS-B (38569), mitochondrial antibody with reflex to titer (259), actin (smooth muscle) IgG (15043), thyroid peroxidase (TPO) antibody (5081), and liver kidney microsome (LKM-1) IgG (15038).

Rheumatoid Arthritis

90071

ANA Screen, IFA, with Reflex to Titer and Pattern/Rheumatoid Arthritis Panel 1 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); also includes rheumatoid factor (4418), cyclic citrullinated peptide (CCP) IgG (11173).

TBD

ANA Screen, IFA, with Reflex to Titer and Pattern/Rheumatoid Arthritis Panel 2 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); also includes rheumatoid factor (4418), cyclic citrullinated peptide (CCP) IgG (11173), and 14-3-3 eta protein (91455).

Sjögren Syndrome

90077

ANA Screen, IFA, with Reflex to Titer and Pattern/Sjögren's Panel 1 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); also includes rheumatoid factor (4418) and SS-A (38568) and SS-B (38569) antibodies.

19880

ANA Screen, IFA, with Reflex to Titer and Pattern/Sjögren's Panel 2 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); mitochondrial antibody screen with reflex to titer (259); rheumatoid factor (4418); and SS-A (38568), SS-B (38569), and thyroid peroxidase antibodies (5081).

Systemic Lupus Erythematosus

19874

ANA Screen, IFA, with Reflex to Titer and Pattern/Lupus Drug Induced Panel 1 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); also includes histone antibody (37056X).

90072

ANA Screen, IFA, with Reflex to Titer and Pattern/Lupus Panel 1 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); also includes chromatin (nucleosomal) (34088), dsDNA (255), and Sm antibodies (37923).

29839

ANA Screen, IFA, with Reflex to Titer and Pattern/Lupus Panel 2 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); also includes dsDNA (255), scleroderma (Scl-70) (4942), Sm (37923), Sm/RNP (38567), SS-A (38568), and SS-B (38569) antibodies.

19881

ANA Screen, IFA, with Reflex to Titer and Pattern/Lupus Panel 3 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); chromatin (nucleosomal) (34088), dsDNA (255), RNP (19887), Sm (37923), SS-A (38568), and SS-B (38569) antibodies; complement components C3c and C4c (5704); and total complement (CH50) (618).

10716

ANA Screen, IFA, with Reflex to Titer and Pattern/Lupus Panel 4 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); dsDNA (255), rheumatoid factor (4418), ribosomal P (34283), Scl-70 (4942), Sm (37923), Sm/RNP (38567), SS-A (38568), SS-B (38569), and thyroid peroxidase (5081) antibodies; and complement components C3c and C4c (5704).

37491

ANA Screen, IFA, with Reflex to Titer and Pattern/Lupus Panel 5b (Panel components may be ordered separately.)

Includes ANA screen (IFA) with reflex to titer and pattern (249); actin (IgG) 15043, gastric parietal cell 15114, rheumatoid factor (4418), ribosomal P (34283), Scl-70 (4942), Sm (37923), Sm/RNP (38567), SS-A (38568), SS-B (38569), and thyroid peroxidase (5081) antibodies; dsDNA (Crithidia) (37092), mitochondrial (259), myocardial (261), reticulin (16530), and striated muscle (266) antibody screens with reflex to titers; and complement components C3c and C4c (5704).

Systemic Sclerosis

90073

ANA Screen, IFA with Reflex to Titer and Pattern/Systemic Sclerosis Panel 1 (Panel components may be ordered separately.)

Includes ANA screen, IFA, with reflex to titer and pattern (249); also includes centromere B (16088), and Scl-70 (4942) antibodies.

ANA, antinuclear antibody; dsDNA, double-stranded DNA; IFA, immunofluorescent assay; RNP, ribonucleoprotein; Scl-70, scleroderma (topoisomerase I); Sm, Smith; and SS-A, SS-B, Sjögren syndrome A and B.

a

Reflex tests are performed at an additional charge and are associated with an additional CPT code(s).

b

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

References

  1. American College of Rheumatology Position Statement: Methodology of testing for antinuclear antibodies. http://www.rheumatology.org/Portals/0/Files/Methodology%20of%20Testing%20Antinuclear%20Antibodies
    %20Position%20Statement.pdf
    . Published January 2009. Updated August 2015. Accessed August 10, 2016.

  2. Satoh M, Vázquez-Del Mercado M, Chan EK, et al. Clinical interpretation of antinuclear antibody tests in systemic rheumatic diseases. Mod Rheumatol. 2009;19:219-228.

  3. International Consensus on ANA Patterns. http://anapatterns.org. Updated 2016. Accessed October 31, 2016.

  4. American College of Rheumatology. Antinuclear Antibodies (ANA). http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Antinuclear-Antibodies-ANA. Updated June 2015. Accessed November 30, 2016.

  5. Satoh M, Chan EK, Sobel ES, et al. Clinical implication of autoantibodies in patients with systemic rheumatic diseases. Expert Rev Clin Immunol. 2007;3:721-738.

  6. Kumar Y, Bhatia A, Minz RW. Antinuclear antibodies and their detection methods in diagnosis of connective tissue diseases: a journey revisited. Diagn Pathol. 2009;4:1-10.

  7. Solomon DH, Kavanaugh AJ, Schur PH; American College of Rheumatology Ad Hoc Committee on Immunologic Testing Guidelines. Evidence-based guidelines for the use of immunologic tests: antinuclear antibody testing. Arthritis Rheum. 2002;47:434-444.

  8. 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. Arch Pathol Lab Med. 2000;124:71-81.

  9. Stinton LM, Fritzler MJ. A clinical approach to autoantibody testing in systemic autoimmune rheumatic disorders. Autoimmun Rev. 2007;7:77-84.

  10. Hoffman IE, Peene I, Meheus L, et al. Specific antinuclear antibodies are associated with clinical features in systemic lupus erythematosus. Ann Rheum Dis. 2004;63:1155-1158.

  11. 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;64:2677-2686.

  12. Cappelli S, Randone SB. "To be or not to be," ten years after: evidence for mixed connective tissue disease as a distinct entity. Semin Arthritis Rheum. 2012;41:589-598.

  13. Cervera R, Viñas O, Ramos-Casals M, et al. Anti-chromatin antibodies in systemic lupus erythematosus: a useful marker for lupus nephropathy. Ann Rheum Dis. 2003;62:431-434.

  14. 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;62:2569-2581.

  15. Shiboski SC, Shiboski CH, Criswell L, et al. American College of Rheumatology classification criteria for Sjögren's syndrome: a data-driven, expert consensus approach in the Sjögren's International Collaborative Clinical Alliance cohort. Arthritis Care Res (Hoboken). 2012;64:475-487.

  16. Scholz J, Grossmann K, Knütter I, et al. Second generation analysis of antinuclear antibody (ANA) by combination of screening and confirmatory testing. Clin Chem Lab Med. 2015;53:1991-2002.

  17. Colglazier CL, Sutej PG. Laboratory testing in the rheumatic diseases: a practical review. South Med J. 2005;98:185-191.

  18. Moder KG, Wener MH, Weisman MH, et al. Measurement of antinuclear antibodies by multiplex immunoassay: a prospective, multicenter clinical evaluation. J Rheumatol. 2007;34:978-986.

  19. Binder SR, Genovese MC, Merrill JT, et al. Computer-assisted pattern recognition of autoantibody results. Clin Diagn Lab Immunol. 2005;12:1353-1357.

  20. Mouthon L, Dunogue B, Guillevin L. Diagnosis and classification of eosinophilic granulomatosis with polyangiitis (formerly named Churg-Strauss syndrome). J Autoimmun. 2014;48-49:99-103.

  21. Tur BS, Süldür N, Ataman S, et al. Anti-neutrophil cytoplasmic antibodies in patients with rheumatoid arthritis: clinical, biological, and radiological correlations. Joint Bone Spine. 2004;71:198-202.

  22. van Paassen P, Damoiseaux J, Tervaert JW. Laboratory assessment in musculoskeletal disorders. Best Pract Res Clin Rheumatol. 2003;17:475-494.

  23. 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;62:2569-2581.

  24. Maksymowych WP, Naides SJ, Bykerk V, et al. Serum 14-3-3 eta is a novel marker that complements current serological measurements to enhance detection of patients with rheumatoid arthritis. J Rheumatol. 2014;41:2104-2113.
     

Content reviewed 01/2017

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* The tests listed by specialist are a select group of tests offered. For a complete list of Quest Diagnostics tests, please refer to our Directory of Services.