ANA Profiles & Guide To Interpretation

RDL Reference Laboratory
Creative Solutions for Complex Medicine
RDL’s ANA Profiles are comprehensive, cost-effective autoantibody panels available for labor-
atory evaluation of suspected anitnuclear antibody (ANA)-positive rheumatoic disease. They
were developed for their clinical relevance as a complete diagnostic aid with potential prognostic
utility. All ANA Profiles are performed refexively. If the ANA is negative, no further testing is
performed except for anti-Ro (SS-A), which is performed at no additional charge. If the ANA is
positive, the entire profile is performed. Any of our ANA Profiles can be ordered as a “Do All”.
UNIQUELY AVAILABLE FROM RDL AT NO ADDITIONAL CHARGE: Immunofluorescence

patterns on routine ANA studies which suggest the prescence of Proliferating Cell Nuclear Antigen
(PCNA), Ribosomal P Protein and Mitochondrial autoantibodies are reflexively evaluated by
raditional techniques.
Ana Profiles in ANA-Positive Rheumatic Disea se

ANTIBODY ACTIVE PRIMARY DRUG-
SPECIFICITY SLE MCTD PSS CREST SJOGREN’S RA INDUCED SLE
ANA >95% >95% 70-90% 60-90% >70% 40-50% 100%

Anti-dsDNA 60% Negative Negative Negative Rare Rare Negative
Anti-Sm 30% Negative Negative Negative Negative Negative Negative
Anti-RNP 30% >95% Common Negative Rare Rare 10-20%

(high titer) (low titer) (low titer) (low titer)
Anti-Centromere Rare Rare 10-15% 60-90% Negative Negative Negative
Anti-Ro (SS-A) 30% Rare Rare Negative 70% 10-15% Negative
Anti-La (SS-B) 15% Rare Rare Negative 60% Rare Negative
Anti-Nucleolar Occasional Negative Common Negative Occasional Rare Negative
Anti-Scl-70 Rare Negative 10-20% Negative Negative Negative Negative
Anti-Histone 24-95% Occasional Occasional Occasional Occasional 20% Procainamide: 67-100%

Sensitivity
Hydralazine: 50-100%
Sensitivity
Guide To Interpretation
1. A negative ANA excludes active Systemic Lupus Erythematosus (SLE) in >95% of cases.
2. False-positive ANAs occur in the following frequencies:
- at 1:40: 32%
- at 1:80: 13%
- at 1:320: 3%
- The number of false-positive ANAs increases with age.
3. Positive ANAs lack specificity, and can occur in many autoimmune rheumatic diseases, chronic inflammatory and
infectious diseases, malignancies, and can also be induced by certain drugs.
4. Although unusual, low titer ANAs (1:40, 1:80) can be accompanied by other autoantibodies including Anti-DNA,
Anti-Chromatin, Anti-RNP, Anti-Ro and others.
5. Anti-Centromere Abs strongly suggest CREST Syndrome and are occasionally seen in Progressive Systemic
Sclerosis (PSS), Raynaud’s Phenomenon and Primary Biliary Cirrhosis.
6. Anti-dsDNA Abs are essentially restricted to SLE and are seen infrequently in severe Rheumatoid Arthritis (RA).
Increases in Anti-dsDNA Ab titers may predict flares in SLE.
7. Anti-Sm Abs are 99% specific for SLE. Sensitivity is higher in Blacks and Asians than Caucasians of European
descent.
8. High titer Anti-RNP Abs (>1:10,000) are characteristic of Mixed Connective Tissue Disease (MCTD), particularly
if unaccompanied by other autoantibody specificities.
9. Anti-RNP Abs, which are diagnostic for MCTD, especially at high titer, are also commonly seen in SLE, but titers
are usually modest. Anti-RNP Abs can also be seen in PSS, Myositis, some RA and Sjogren’s in low to modest
titers.
10. Anti-Ro and Anti-La Abs are most often seen in Primary Sjogren’s Syndrome, less frequently in SLE and least
frequently in Secondary Sjogren’s Syndrome. Anti-Ro and Anti-La Abs are strongly associated with Subacute
Cutaneous LE, Neonatal Lupus Dermatitis, Congenital Complete Heart Block and rarely in Lupus Nephritis.
11. Anti-Ro Ab has also been associated with:
- Photosensitive skin rash in SLE - Thrombocytopenia (SLE, Sjogren’s)
- Homozygous C2 Deficiency in SLE-like illness - Lymphopenia (SLE, Sjogren’s)
- Congenital Complete Heart Block - Nephritis, Anti-Ro without Ant-La
- Interstitial Pneumonitis Disease in SLE
- Pregnant women with Lupus accompanied by Anti-Ro have a 5% chance of having an infant with Congenital
Complete Heart Block
- Asymptomatic mothers of infants born with Congenital Complete Heart Block are at increased risk of
developing a Connective Tissue Disease.
12. Anti-Scl-70 Abs (Anti-Topoisomerase 1 Abs) are seen in PSS and corrolate with Pulmonary Fibrosis.
13. Anti-PCNA (Proliferating Cell Nuclear Ag) Abs are highly specific for SLE, but sensitivity is only ~4%.
14. Anti-Ribosomal P Protein Abs:
- Psychosis/depression in SLE: 45-90% reported (controversial)
- Highly specific for SLE occurring in 10-20% of patients
- CNS neuropsychiatric association in children and adolescents is less reliable than in adults.
15. Anti-Chromatin Abs:
- Useful marker for SLE with Nephritis and can be seen in the absence of Anti-DNA
- Seen in SLE with sensitivity of 70%
- Seen in Drug Induced LE where it targets H2A - H2B linked to DNA which appears to be the major antigen in
Drug Induced LE compared to Anti-Histone Abs which are directed against potentially all histone components
H1, H2A, H2 B, H3, H4 as well as H2A-H2B-DNA in SLE and other disorders.
- Can help to distinguish Drug Induced LE (Anti-H2A-H2B-DNA) compared to Drug Induced ANA.
- Specificity overall is good for SLE, Drug Induced LE, but can be seen in PSS, RA, MCTD and Type I Chronic
Autoimmune Hepatitis.
16. Anti-Mitochondrial Abs are associated with Primary Biliary Cirrhosis, Scleroderma and CREST Syndrome.
17. Anti-Thyroid Microsomal (Thyroid Peroxidase) Abs are associated with Autoimmune Thyroid Disease, are
predictive of development of biochemical Hypothyroidism and occur commonly with positive ANAs.
18. Anti-Histone Abs may help in confirming a suspicion of Drug Induced LE but cannot distinguish Drug Induced
ANA from Drug Induced LE which typically targets H2A-H2B-DNA (Anti-Chromatin), particularly in Pronestyl
Induced LE.
- 95% of Drug Induced LE
- 70-80% of SLE
- Can be seen occasionally Scleroderma, RA, Sjogren’s, JRA, Felty’s Syndrome, MCTD, Vasculitis Neo-
plasms and Liver Disease.
RDL Reference Lab offers four reflexive ANA Profiles. The two most popular
ANA Profiles are the ANA 12 Profile and the ANA 12 Plus Profile.
ANA 12 Profile
Anti-Nuclear Ab Anti-Centromere Ab
Anti-dsDNA Ab C3 & C4 Complements
Anti-Ro Ab (SS-A) Anti-Thyroid Microsomal Ab
Anti-La Ab (SS-B) Anti-Cardiolipin Abs
Anti-SM Ab (IgG, IgA, IgM Isotypes)
Anti-RNP Ab Anti-Chromatin Ab, IgG
Anti-Scl-70 Ab (Anti-Nucleosome Abs)
ANA 12 Plus Profile assists in the evaluation of polyarthritis and

related systemic autoimmune diseases that may be characterized by
ANA positivity. The ANA 12 Plus Profile will be identical to the ANA 12
Profile with the addition of Anti-Cyclic Citrullinated Peptide Antibody
(Anti-CCP) and Rheumatoid Factor by Nephelometry.
The ANA 12 Plus Profile will enhance the serologic evaluation of these
diseases when accompanied by inflammatory polyarthritis.
ANA 12 Plus Profile
Anti-Nuclear Ab Anti-Centromere Ab
Anti-dsDNA Ab C3 & C4 Complements
Anti-Ro Ab (SS-A) Anti-Thyroid Microsomal Ab
Anti-La Ab (SS-B) Anti-Cardiolipin Abs
Anti-SM Ab (IgG, IgA, IgM Isotypes)
Anti-RNP Ab Anti-Chromatin Ab, IgG
Anti-Scl-70 Ab (Anti-Nucleosome Abs)
Anti-Cyclic Citrullinated Peptide Ab (CCP)
Rheumatoid Factor By Nephelometry

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RDL Reference Laboratory

Creative Solutions for Complex Medicine

UNIQUELY AVAILABLE FROM RDL AT NO ADDITIONAL CHARGE: Immunofluorescence

Ana Profiles in ANA-Positive Rheumatic Disea se

ANA >95% >95% 70-90% 60-90% >70% 40-50% 100%

Anti-Sm 30% Negative Negative Negative Negative Negative Negative

Anti-RNP 30% >95% Common Negative Rare Rare 10-20%

Anti-Centromere Rare Rare 10-15% 60-90% Negative Negative Negative

Anti-Ro (SS-A) 30% Rare Rare Negative 70% 10-15% Negative

Anti-La (SS-B) 15% Rare Rare Negative 60% Rare Negative

Anti-Nucleolar Occasional Negative Common Negative Occasional Rare Negative

Anti-Scl-70 Rare Negative 10-20% Negative Negative Negative Negative

Anti-Histone 24-95% Occasional Occasional Occasional Occasional 20% Procainamide: 67-100%

ANA 12 Plus Profile assists in the evaluation of polyarthritis and

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