Anti-Nuclear Antibody (ANA) Testing By Doctors For Doctors

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1 Anti-Nuclear Antibody (ANA) Testing By Doctors For Doctors Updated March 2014

2 Clinical Expertise Our Medical Directors are board certified Rheumatologists. RDL has performed our ANA assay exclusively by Indirect Immunofluorescence (IFA) for over thirty years. All of our technologists have over 25 years of experience in immunologic testing and interpretation, and are trained to read ANAs for six months, before performing unsupervised work. RDL has been CAP and CLIA certified since Personal Service Our Medical Directors contact you to personally discuss complex results, and are available for clinical consultation on any of your other test results, as well. Real people answer our phones, so you can get an immediate response to all your questions and concerns. We are a provider for Medicare and Blue Cross/Blue Shield, as well as many other plans throughout the country, and we can usually adapt to your patient s plan. We are sensitive to your patients financial concerns, and can offer unique plans to work within their budget. Cost Effective RDL s reflexive panels are more cost-effective than performing individual tests and provide more comprehensive results. RDL offers free courier service throughout the United States. All serum specimens are routinely stored for a period of 2 months, facilitating the ease of add-on testing.

3 The Gold Standard in ANA Testing RDL s ANA 12 Plus Profile uniquely combines multiple autoantibody tests utilizing 6 different methodologies to provide the most comprehensive and highly accurate evaluation of systemic autoimmune disease. RDL performs ANA assays exclusively by Indirect Immunofluorescence (IFA) and the patterns/titers are interpreted by technologists with over 35 years of IFA experience. We do not use ELISA for our ANA testing and do not use automated IFA readers for pattern recognition. During routine IFA ANA testing, our technologists are able to detect and report patterns that suggest the presence of other autoantibodies, such as Anti-Ribosomal P Ab, Anti-Mitochondrial Ab, and Anti-Jo-1 Ab. When specific cytoplasmic staining is identified, RDL automatically perform ELISA testing for these autoantibodies, at no additional cost. RDL performs Anti-dsDNA antibody testing by the FARR assay, which has a higher avidity and is highly specific for SLE. RDL can also perform anti-dsdna antibody testing via the Crithidia and ELISA methods, if specifically requested. RDL confirms all Scl-70 positive ELISA test results by Immunodiffusion, which is highly specific for scleroderma. RDL includes anti-chromatin antibodies and anti-tpo antibodies to help indentify positive ANAs related to drug-induced SLE or autoimmune thyroid disease, respectively. The ANA 12 Plus Profile helps differentiate between 8 autoimmune disease states. Because of its national reputation, RDL was chosen to perform autoantibody testing for the Systemic Lupus International Collaborating Clinics (SLICC) published Classification Criteria for Systemic Lupus Erythematosus in (Petri M et al. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis & Rheumatism 2012; 64: )

4 The ANA 12 Plus Profile is a reflexive assay, as are all of our ANA profiles. If the ANA titer is negative, no further tests are performed except for Anti-Ro Ab, which is done at no additional charge. Anti-Ro is performed to find the very small percentage of false negative ANAs. If the ANA titer is positive, the complete profile is performed. If the ANA 12 Plus Profile is ordered as a DO ALL, then all profile tests are performed automatically. No Further Testing Anti-Ro ANA Positive All Tests Performed Positive All Tests Performed Anti-Nuclear Ab (ANA), Pattern and Titer Anti-Centromere Ab Anti-Scl-70 Ab (Anti-Topoisomerase 1) Anti-dsDNA Ab by Farr Anti-Chromatin Ab Anti-Ro Ab, (SS-A) Anti-LA Ab, (SS-B) Anti-Smith Ab (Anti-SM) Anti-Ribonucleoprotein Ab (Anti-RNP) C3 Complement C4 Complement Anti-Cardiolipin Abs (ACA), IgG, IgA and IgM Anti-Thyroid Microsomal Ab (TPO) Rheumatoid Factor (RF), IgM Anti-Cyclic Citrullinated Peptide Ab (CCP) All serum specimens are routinely stored for a period of 2 months, facilitating the ease of add-on testing. Clinical Utility The ANA test detects autoantibodies that bind to the nuclear components of HEp-2 cells. A positive ANA titer is not specific, but indicates the presence of one or more autoantibodies. Profiles of specific autoantibodies have diagnostic and potential prognostic utility for several autoimmune diseases.

5 RDL s ANA 12 Plus Profile Helps Differentiate Between 8 Autoimmune Disease States SLE ANA by IFA Tests with high specificity Anti-dsDNA by Farr Anti-SM Tests with moderate specificity Anti-Ro Anti-La Anti-Chromatin C3 & C4 Complements Anticardiolipin IgG, IgA & IgM Drug-induced SLE Anti-Chromatin Sjogren s Syndrome Anti-Ro Anti-La Rheumatoid Arthritis Anti-CCP (high specificity) Rheumatoid Factor (Turbidimetry) Mixed Connective Tissue Disease (MCTD) Anti-U1RNP Limited Scleroderma (CREST) Anti-Centromere Diffuse Scleroderma Anti-SCL-70 by EIA, confirmed by ID Autoimmune Thyroid Disease Anti-Thyroid Microsomal (TPO)

6 Sensitivity of ANA and Other Autoantibodies in Common Rheumatic Diseases ANTIBODY SPECIFICITY ACTIVE SLE MCTD DIFFUSE SSc LIMITED SSc (CREST) PRIMARY SJOGREN S RA DRUG- INDUCED SLE ANA >95% >95% 70-90% 60-90% >70% 40-50% 100% Anti-Centromere 10-15% 50% Anti-dsDNA 60% 90% of Anti-TNFα Induced SLE Anti-Chromatin 50-90% Procainamide >90% Hydralazine <50% Anti-Ro (SS-A) 70% 10-15% Anti-LA (SS-B) 15% 60% Anti-Sm Anti-RNP >95% (high titer) 5% 2-14% (low titer) 10-20% (low titer) Anti-Scl-70 20% 10% Anticardiolipin 12-44% Uncommon Anti-TPO 40% Uncommon Uncommon Common 10-20% RF 40% 15% 75-90% 70-75% CCP 5-10% 70-80% Autoimmune disorders can be challenging to diagnose and differentiate from other conditions. Our Medical Directors are available to discuss any laboratory results and clinical cases. Please visit our website, for additional information. March 2014, RDL, Inc. RDL Reference Laboratory Creative Solutions for Complex Medicine Venice Boulevard Los Angeles, CA tel: fax: