Advancing Patient Care
Autoimmune Profiles
Autoimmune disorders can be challenging to diagnose and differentiate from other conditions. Labcorp offers a wide range of autoimmune profiles to help diagnose and characterize disease.
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Browse profiles and related tests
Rheumatoid arthritis profiles
Diagnosis and classification of rheumatoid arthritis (RA) have relied heavily on the presence of Rheumatoid Factor (RF) and Anti-CCP (Cyclic Citrullinated Peptide). However, 20–25% of patients with RA (and up to 50% of those with suspected early RA) may be seronegative for both RF and Anti-CCP.1 Novel markers may be useful in identifying more early RA patients, stratifying patients at risk of joint destruction and monitoring disease activity and treatment response.
Most comprehensive diagnostic and prognostic profile for RA. Along with RF and Anti-CCP Ab, it includes four novel markers (14-3-3 eta, Anti-CEP-1, Anti-Sa, and Anti-CarP) that enhance the ability to diagnose early or established RA as well as to predict disease severity.
Rheumatoid Factor (RF) by Turbidimetry , Anti-CCP (Cyclic Citrullinated Peptide) Ab, IgG & IgA, 14-3-3 eta, Anti- CEP1 (citrullinated alpha-enolase 1) Ab, Anti-Sa (citrullinated vimentin) Ab, Anti-CarP (carbamylated protein) Ab
Novel reflexive profile for RA that if negative for traditional markers, RF and Anti-CCP, reflexes to four novel markers (14-3-3 eta, Anti-CEP1, Anti-Sa, Anti-CarP) that comprise SeroNeg RAdx4 which is designed to enhance diagnosis of RA and early RA as well as predict disease severity
RA Profile (Rheumatoid Factor and Anti-CCP) with Reflex to SeroNeg RAdx4 (14-3-3 eta, Anti-CEP1, Anti-Sa, Anti-CarP
Diagnostic profile for Seronegative patients (who have tested RF-negative and Anti-CCP- negative) designed to enhance the diagnosis of RA and early RA. It is comprised of four novel markers (14-3-3 eta, Anti-CEP1, Anti-Sa, Anti-CarP) that may also predict RA disease severity
14-3-3 eta protein; Anti-CEP1 (citrullinated alpha-enolase 1) Ab; Anti-Sa (citrullinated vimentin) Ab; Anti-CarP (carbamylated protein) Ab
Profile for Rheumatoid Arthritis that may increase the specificity and predictive value of RF by Turbimetry (a separate test) when all three RF isotypes are detected. This profile may also help predict joint damage
RF IgG, IgA and IgM isotypes are determined by individual enzyme immunoassays
ANA profiles and related tests
Anti-nuclear antibody (ANA) by indirect immunofluorescence assay (IFA) is the gold standard screening test that detects autoantibodies to the nuclear components of HEp-2 cells.2 A positive ANA by IFA is reported as titer and pattern. However, IFA patterns are not always specific. Profiles comprised of monospecific assays for individual autoantibodies have diagnostic and potential prognostic utility for several autoimmune diseases.
Comprehensive diagnostic profile deliberately curated to aid in the differential diagnosis of eight autoimmune disease states: systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, limited scleroderma, diffuse scleroderma, drug-induced lupus and autoimmune thyroid disease
This profile includes unique reflexing strategies designed to detect more true positives and Anti-double stranded DNA by Farr radioimmunoassay which has very high specificity for SLE and is reported as a numeric result with reference range of <8.0 IU/m
ANA by IFA is performed and reported with titer and pattern. A lower cutoff 1:40 increases the diagnostic sensitivity
This profile is reflexive; if ANA is positive, the following 14 components are performed:
- Anti-dsDNA Ab by Farr, Anti-Sm, C3 Complement; C4 Complement, Anti-Cardiolipin Ab (IgG, IgA & IgM Isotypes), Anti-U1 RNP, Anti-Ro (SS-A) Ab,Anti-La (SS-B) Ab,RF by Turbimetry, Anti-CCP (Cyclic Citrullinated Peptide) Ab, Anti-Centromere Ab, Anti-Scl-70 Ab, Anti-Chromatin Ab , Anti-TPO (Thyroid Microsomal Peroxidase) Ab
- If ANA is negative, an Anti-Ro (SS-A) Ab is performed to catch the small percentage of false negative ANA by IFA. If Anti-Ro is positive, then all profile components are performed
Anti-Scl70 positivity by ELISA is confirmed using a second method to improve its predictive value in identifying diffuse scleroderma
Unique screening profile with the novel Anti-DFS70 that may help identify SLE, MCTD, Sjögren syndrome, systemic sclerosis, idiopathic myopathy (IIM), and contributes to the inclusion or exclusion of these autoimmune rheumatic diseases (AARD). Positive Anti-DFS70, especially when positive in isolation confers a likelihood ratio of 10.9 for the absence of systemic autoimmune rheumatic disease (SARD)
Anti-DFS70 Ab, Anti-Sm Ab, Anti-U1 RNP Ab, Anti-Ro (SS-A) Ab, Anti-La (SS-B) Ab, Anti-Scl70 Ab, Anti-Jo1 Ab
Do All is not reflexive; it is a separate test code; all components of ANA 12 Plus are always performed and reported
Anti-DFS70 antibodies may help identify individuals who do not have an AARD, especially in the absence of significant clinical findings.3
Myositis profiles and related tests
Inflammatory myopathies (or idiopathic inflammatory myopathies), commonly known as myositis, including dermatomyositis, polymyositis, anti-synthetase syndrome and overlap myositis, are systemic diseases that affect multiple organs and can cause severe impairment.
Most comprehensive diagnostic myositis profile designed to cast the widest net for autoantibodies indicative of dermatomyositis (DM), polymyositis (PM), and anti-synthetase syndrome as well as other diseases that overlap with idiopathic inflammatory myopathies (IIM)
This unique profile featuring gold standard RIPA gel radiography aids not only in differential diagnosis but also in characterization of disease pattern, severity and other risks
Anti-Jo-1 Ab, Anti-PL-7 Ab, Anti-PL-12 Ab, Anti-EJ Ab, Anti-OJ Ab, Anti-MDA5 Ab (CADM-140), Anti-NXP-2 Ab, Anti-TIF-1γ Ab, Anti-SAE1 Ab, Anti-Mi-2 Ab, Anti-SRP Ab, Anti-SS-A 52kD Ab, Anti-Ku Ab, Anti-U1 RNP Ab, Anti-U2 RNP Ab, Anti-U3 RNP (Fibrillarin Ab), Anti-PM/Scl-100 Ab
Marker specific for a distinct form of myositis, sporadic inclusion body myositis (sIBM)
Marker associated with and specific for necrotizing myopathy most often caused by exposure to statin drugs
MyoMarker® 3 Plus employs RIPA gel radiography. This complex method utilizes immunoprecipitation, gel electrophoresis (SDS-PAGE) and autoradiography to identify radioisotope-labelled proteins from human erythroleukemic cell extracts that are targeted by autoantibodies in patient serum. RIPA gel radiography is a powerful, reliable technology that has been used and refined over more than 30 years to identify many PM/DM autoantibodies with high sensitivity, specificity and reproducibility. It is the original methodology of studies that defined various myositis-specific and myositis-associated antibodies.7
Scleroderma profile and related tests
Scleroderma or systemic sclerosis is a systemic autoimmune rheumatic disease (SARD) characterized by hardening of the skin and other organs. Testing is centered on diagnosis and differentiation between limited (also known as CREST syndrome with calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly and telangiectasia) and diffuse forms.
Most comprehensive scleroderma profile designed to facilitate early diagnosis and intervention as well as differentiation between limited and diffuse forms of scleroderma
Anti-Nuclear Ab (ANA) by IFA, Anti-Centromere Ab, Anti-Th/To Ab, Anti-U1 RNP Ab, Anti-U3 RNP (Fibrillarin) Ab, Anti-RNA Polymerase III Ab, Anti-Scl 70 Ab, Anti-PM/Scl-75 Ab, Anti-PM/ Scl-100 Ab
Important marker for scleroderma, incorporating a unique second method that improves positive predictive value
Interstitial lung disease profiles
Interstitial lung disease (ILD) is a frequent manifestation and cause of morbidity and mortality in systemic autoimmune rheumatic diseases (SARD) including systemic sclerosis (SS), Sjögren's syndrome (SjS), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), idiopathic inflammatory myopathies (IIM) and ANCA-associated vasculitis (AAV). Early detection and diagnosis of ILD and its underlying SARD may offer the opportunity to target management and improve clinical course by suppressing lung inflammation, restricting fibrotic response and limiting irreversible tissue damage.5
Unique, comprehensive profile to diagnose underlying autoimmune diseases that can cause ILD and to identify rheumatic patients at risk for rapidly progressive ILD
Anti-Scl-70 Ab, Anti-PM/Scl-100 Ab, Anti-Jo-1 Ab, Anti-EJ Ab, Anti-OJ Ab , Anti-PL-7 Ab, Anti-PL-12 Ab, Anti-MDA5 Ab, Anti-SRP Ab. Anti-Ku Ab, Anti-SSA 52 kD Ab
ANA by IFA, If positive, reflexes to Anti-dsDNA by Farr, Anti-Sm Ab, Anti-U1 RNP Ab, Anti-La (SS-B) Ab, Anti-Ro (SS-A) Ab
ANCA by IFA, if positive, reflexes to Anti-MPO Ab and Anti-PR3 Ab, RF by Turbimetry, Anti-CCP Ab
Profile to identify myositis patients at risk for ILD
Anti-PM/Scl-100 Ab, Anti-Jo-1 Ab, Anti-EJ Ab, Anti-OJ Ab, Anti-PL-7 Ab, Anti-PL-12 Ab, Anti-MDA5 Ab, Anti-SRP Ab, Anti-Ku Ab, Anti-SSA 52 kD Ab
MyoMarker® 3 Plus, Scleroderma Comp Plus, ILDdx and Interstitial Lung Profiles employ RIPA gel radiography. RIPA gel radiography is a powerful, reliable technology that has been used and refined for more than 30 years to identify many PM/DM autoantibodies with high sensitivity, specificity and reproducibility. It is the original methodology of studies that defined various myositis-specific and myositis-associated antibodies.7
Sjögrenʼs profile and related test
Sjögrenʼs syndrome is a systemic autoimmune rheumatic disease (SARD) characterized by dry eyes, dry mouth and fatigue and can involve multiple organs such as the kidneys, gastrointestinal system, blood vessels, lungs, liver, pancreas and the central nervous system.
Unique Sjögrenʼs profile with Anti-Fodrin Abs to improve early diagnosis
Anti-Ro (SS-A) Ab; Anti-La (SS-B) Ab; Anti-Fodrin Abs, IgG and IgA
Unique markers that may improve the ability to diagnose early stage Sjögrenʼs
ANCA profile and other related tests
Other autoimmune diseases like ANCA-associated vasculitides (AAV), inflammatory bowel disease (IBD) and autoimmune liver disease may be characterized by the presence of specific autoantibodies.
Diagnostic profile to identify the ANCA-associated vasculitides (AAV), also known as small vessel vasculitides: granulomatosis with polyangiitis (GPA; formerly called Wegenerʼs granulomatosis), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA; formerly called Churg-Strauss syndrome)
ANCA (Anti-Neutrophil Cytoplasmic Ab) by immunofluorescence assay (IFA);
Anti-MPO (Myeloperoxidase) Ab and Anti-PR-3 (Proteinase 3) Ab by enzyme immunoassays; Depending on staining patterns on ethanol- and formalin-fixed neutrophils, c-ANCA, p-ANCA or atypical p-ANCA is resulted with titers, if positive. Otherwise, ANCA is reported as negative. Anti-Nuclear Ab (ANA) by IFA is performed if ANCA-positive to rule out false positive ANCA due to the presence of ANA
Diagnostic profile designed to identify autoimmune causes of vasculitis including lupus, ANCA-associated vasculitides (AAV) and Anti-GBM disease
ANA by IFA, ANCA by IFA, Anti-MPO Ab, Anti-PR3 Ab, Anti-GBM Ab, RF by Turbimetry, Anti- dsDNA Ab by Farr (RDL), C3 Complement, C4 Complement
Diagnostic profile designed to identify underlying autoimmune causes of glomerulonephritis including lupus, ANCA-associated vasculitides (AAV), and Anti-GBM (glomerular basement membrane) or Goodpasture's disease
Anti-Nuclear Ab (ANA) by IFA, Anti-Neutrophil Cytoplasmic Ab (ANCA), Anti-Myeloperoxidase Ab (MPO), Anti-Proteinase 3 Ab (PR-3), Anti-GBM Ab, Anti-dsDNA Ab by Farr, C3 Complement, C4 Complement
Gastroenterology profiles
Novel serological markers for inflammatory bowel disease (IBD) and autoimmune liver disease improve sensitivity and specificity to aid in differential diagnosis and provide valuable prognostic information about disease behavior.
Diagnostic profile including the novel Anti-Glycan Ab designed to help differentiate inflammatory bowel disease (IBD) from non-IBD and Crohnʼs disease (CD) from ulcerative colitis (UC)6
Anti-Glycan Ab: ASCA (Anti-Saccharomyces Cerevisiae Ab, ACCA (Anti-Chitobioside Carbohydrate Ab), ALCA (Anti-Laminaribioside Carbohydrate Ab), AMCA (Anti-Mannobioside Carbohydrate Ab)
Diagnostic profile to identify and differentiate between autoimmune hepatitis types 1 and 2
Anti-Nuclear Ab (ANA) by IFA, ANCA by IFA, Anti-Chromatin Ab, Anti-Liver/Kidney Microsomal Ab, Anti-Mitochondrial M2 EP (MIT3) Ab, Anti-Soluble Liver Ag Ab, Anti-Smooth Muscle Ab IFA, Anti-Mitochondrial Ab by IFA
Autoimmune test list
Rheumatoid Arthritis Profiles
| Number | Name |
|---|---|
| 520304 | RAdx6 Profile |
| 520305 | SeroNeg RAdx4 Profile |
| 520298 | Rheumatoid Arthritis (RA) Profile with Reflex to SeroNeg RAdx4 |
| 520178 | Rheumatoid Factor Isotypes, IgG, IgA, and IgM by EIA (RDL) |
ANA and Related Tests
Myositis Profile and Related Tests
| Number | Name |
|---|---|
| 520085 | MyoMarker® 3 Plus Profile (RDL) |
| 520057 | Anti-HMGCR Ab (RDL) |
| 520061 | Anti-cN-1A Ab (NT5c1A) IBM (RDL) |
Scleroderma Comprehensive Plus Profile (RDL)
| Number | Name |
|---|---|
| 520130 | Scleroderma Comprehensive Plus Profile (RDL) |
| 520202 | Interstitial Lung Disease Profile (RDL) |
Interstitial Lung Disease Profiles
| Number | Name |
|---|---|
| 520210 | ILDdx Profile (RDL) |
| 520202 | Interstitial Lung Disease Profile (RDL) |
Sjögren's Profile and Related Test
| Number | Name |
|---|---|
| 520196 | Sjogren's Profile Plus (RDL) |
| 520134 | Anti-Fodrin Antibodies, IgG & IgA (RDL) |
ANCA Profile and Other Related Tests
| Number | Name |
|---|---|
| 520149 | ANCA Profile (RDL) |
| 520194 | Glomerulonephritis (GNP) Profile (RDL) |
| 520293 | Vasculitis Profile (RDL) |
Gastroenterology Profiles
| Number | Name |
|---|---|
| 162045 | Inflammatory Bowel Disease (IBD) Expanded Profile |
| 520197 | Autoimmune Liver Disease Profile (RDL) |
Additional resources
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References
- Coffey CM, Crowson CS, Myasoedova E, Matteson EL, Davis JM. Evidence of diagnostic and treatment delay in seronegative rheumatoid arthritis: Missing the window of opportunity. Mayo Clin Proc. 2019;94(11):2241-2248. doi: 10.1016/j.mayocp.2019.05.023. Epub 2019 Oct 13. PMID: 31619364; PMCID: PMC6947665.
- 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;73:17–23. 2014;9(4):e93812-e93812.
- Conrad K, Röber N, Andrade LEC, Mahler M. The clinical relevance of anti-DFS70 autoantibodies. Clinic Rev Allerg Immunol. 2017;52:202-216.
- Fitch-Rogalsky C, Steber W, Mahler M, et al. Clinical and serological features of patients referred through a rheumatology triage system because of positive antinuclear antibodies. PLoS One. 2014;9(4):e93812.
- Panagopoulos P, Goules A, Hoffmann-Vold AM, Matteson EL, Tzioufas A. Natural history and screening of interstitial lung disease insystemic autoimmune rheumatic disorders. Ther Adv Musculoskelet Dis. 2021;13:1759720X211037519.
- Bonneau J, Dumestre-Perard C, Rinaudo-Gaujous M, et al. Systematic review: new serological markers (anti-glycan, anti-GP2, anti-GM-CSF Ab) in the prediction of IBD patient outcomes. Autoimmun Rev. 2015;14(3):231-245. doi:10.1016/j.autrev.2014.11.004.
- Satoh M, Chan EK, Sobel ES, et al. Clinical implication of autoantibodies in patients with systemic rheumatic diseases. Expert Review of Clinical Immunology. 2007;3(5):721-738. doi:10.1586/1744666X.3.5.721.8.