Advancing Patient Care in Rheumatology and Autoimmune Disease

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

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

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

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

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

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

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