Scleroderma Panel

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Autoantibody panel.

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Scleroderma Panel - Comprehensive Medical Test Information Guide

Section 1: Why is it done?
- Test Purpose: The Scleroderma Panel is a serological test that detects specific autoantibodies and markers associated with systemic sclerosis (scleroderma) and related autoimmune connective tissue diseases. It measures multiple antibodies including anti-centromere (ACA), anti-topoisomerase I (anti-Scl-70), anti-RNA polymerase III, anti-U3 RNP, and other scleroderma-specific antigens.
- Primary Indications: Suspected systemic sclerosis diagnosis; evaluation of Raynaud's phenomenon; assessment of skin thickening or fibrosis; investigation of pulmonary complications; screening for scleroderma-associated renal crisis; evaluation of unexplained dysphagia or esophageal dysfunction; assessment of suspected mixed connective tissue disease; monitoring disease progression and organ involvement
- Clinical Circumstances: Performed when patients present with progressive skin fibrosis, digital ulcers, or joint contractures; when systemic manifestations suggest connective tissue disease; during initial diagnostic workup for autoimmune conditions; when assessing disease activity and predicting organ involvement; performed early in disease course to establish baseline antibody status and predict clinical phenotype
Section 2: Normal Range
- Reference Values: All scleroderma-specific antibodies: NEGATIVE or <1.0 units/mL (varies by laboratory and methodology); Anti-Centromere Antibody (ACA): Negative; Anti-Topoisomerase I (Anti-Scl-70): Negative; Anti-RNA Polymerase III: Negative; Anti-U3 RNP: Negative; Anti-PM-Scl: Negative; Anti-Fibrillarin: Negative; Anti-Ku: Negative; Anti-Th/To: Negative
- Units of Measurement: Results typically reported as Negative/Positive; Qualitative (Present/Absent); or Quantitative (in units/mL, ratios, or by titer level); Some laboratories use AI (Activity Index) or signal-to-cutoff ratios
- Result Interpretation: NEGATIVE results: No detectable scleroderma-specific antibodies; does not exclude disease but less likely if clinical suspicion is high; approximately 20-30% of scleroderma patients are seronegative. POSITIVE results: Strongly indicative of systemic sclerosis or related autoimmune disease; helps confirm diagnosis and establish disease phenotype; different antibody patterns indicate different clinical presentations and prognoses
- Borderline/Equivocal Results: Low-positive titers; weakly positive results; may warrant repeat testing; clinical correlation essential; may indicate early disease or require investigation for other connective tissue diseases
Section 3: Interpretation
- Anti-Centromere Antibody (ACA) Positive: Associated with limited cutaneous sclerosis (lcSSc); indicates distal skin involvement primarily; lower risk of early pulmonary fibrosis; increased risk of pulmonary hypertension; better overall prognosis; associated with CREST syndrome; found in 70-80% of lcSSc patients
- Anti-Topoisomerase I (Anti-Scl-70) Positive: Associated with diffuse cutaneous sclerosis (dcSSc); indicates extensive proximal skin involvement; highest risk for progressive pulmonary fibrosis; increased renal crisis risk; more aggressive disease course; associated with poor prognosis; found in 30-40% of SSc patients
- Anti-RNA Polymerase III Positive: Rare in SSc (3-4% of patients); strongly associated with scleroderma renal crisis; associated with severe systemic manifestations; diffuse skin involvement; associated with poor outcome if renal crisis develops; indicates need for aggressive monitoring and early intervention
- Anti-U3 RNP Positive: Found in 10-13% of SSc patients; associated with pulmonary hypertension and pulmonary fibrosis; indicates higher risk of lung disease; often seen in overlap syndromes; increased cardiac involvement; requires close monitoring of respiratory function
- Anti-PM-Scl Positive: Found in 3-8% of SSc patients; associated with overlap syndrome features; indicates myositis component; increased risk of interstitial lung disease; associated with more systemic manifestations; may have better prognosis than anti-Scl-70 positive patients
- Multiple Positive Antibodies: Usually mutually exclusive patterns; simultaneous positivity rare; when present, suggests severe disease; may indicate overlap syndromes; warrants extended autoimmune workup
- Seronegative Results: Negative does not exclude scleroderma diagnosis; occurs in 20-30% of SSc patients; typically associated with better prognosis; lower risk of internal organ involvement; less aggressive disease course; still requires clinical correlation and other diagnostic methods
- Factors Affecting Results: Test methodology used (ELISA, immunoprecipitation, nucleoimmunology); laboratory-specific reference ranges; time since disease onset (antibodies may develop over time); immunosuppressive therapy may affect antibody levels; certain medications can influence results; disease activity fluctuations; presence of other autoimmune conditions; genetic predisposition
Section 4: Associated Organs
- Primary Organ Systems: Skin (integumentary system): Primary target organ with fibrosis and sclerosis; Lungs (respiratory system): Interstitial lung disease and pulmonary hypertension; Kidneys (renal system): Scleroderma renal crisis and glomerulonephritis; Esophagus/GI tract: Dysmotility and reflux; Heart: Myocarditis and arrhythmias; Joints: Arthralgia and contractures
- Associated Medical Conditions: Systemic Sclerosis (limited and diffuse cutaneous forms); Scleroderma Renal Crisis; Interstitial Pulmonary Fibrosis; Pulmonary Hypertension; Systemic Sclerosis-Interstitial Lung Disease; Overlap syndromes (with SLE, myositis, Sjögren's); Secondary Raynaud's Phenomenon; Digital Ulcers and Gangrene; Gastrointestinal Dysmotility; Sclerodermatous GVHD in transplant patients
- Pulmonary Complications: Interstitial lung disease (ILD) present in 50-80% of SSc patients; progressive dyspnea; restrictive lung patterns; reduced DLCO; anti-Scl-70 and anti-U3 RNP associated with higher ILD risk; pulmonary hypertension independent of ILD; increased mortality if progressive
- Renal Manifestations: Scleroderma renal crisis: acute kidney injury with hypertensive crisis; anti-RNA polymerase III highly associated; rapidly progressive glomerulonephritis; acute renal failure risk; thrombotic microangiopathy; proteinuria and hematuria; requires emergency intervention; can lead to end-stage renal disease
- Cardiac Involvement: Myocardial fibrosis and dysfunction; arrhythmias including conduction abnormalities; pericarditis; increased sudden cardiac death risk; anti-centromere associated with pulmonary hypertension; heart failure from systemic manifestations; elevated troponin levels
- Gastrointestinal Complications: Esophageal dysmotility and strictures; gastroesophageal reflux disease; malabsorption; small bowel pseudo-obstruction; bacterial overgrowth; gastroparesis; intestinal hypomotility; increased risk of esophageal adenocarcinoma; dysphagia and nutritional deficiency
Section 5: Follow-up Tests
- Initial Diagnostic Workup: Comprehensive metabolic panel (renal function, liver function); Complete blood count; Erythrocyte sedimentation rate (ESR); C-reactive protein (CRP); Thyroid function tests; Thyroid peroxidase and thyroglobulin antibodies; Antinuclear antibody (ANA) with reflex panel; Rheumatoid factor; Anti-cyclic citrullinated peptide (anti-CCP)
- Pulmonary Assessment: High-resolution computed tomography (HRCT) chest; Pulmonary function tests (PFTs) including DLCO; 6-minute walk test; Transthoracic echocardiography for pulmonary hypertension screening; Baseline and periodic monitoring per ACR/EULAR guidelines
- Renal Monitoring: Serum creatinine and eGFR; Urinalysis with microscopy; 24-hour urine protein; Blood pressure monitoring (especially for anti-RNA polymerase III positive patients); Baseline renal ultrasound; Renal biopsy if indicated; Close monitoring for early signs of scleroderma renal crisis
- Cardiac Evaluation: 12-lead electrocardiogram (ECG); Transthoracic echocardiography; Troponin levels; Brain natriuretic peptide (BNP) or N-terminal pro-BNP; Holter monitor if arrhythmias suspected; Cardiac MRI for myocardial involvement; Baseline and periodic assessments
- Gastrointestinal Assessment: Esophageal pH monitoring; Esophageal manometry; Upper endoscopy if dysphagia present; Hydrogen breath test for bacterial overgrowth; Gastric emptying studies if gastroparesis suspected; Assessment for malabsorption
- Monitoring Schedule: Baseline assessment within 3 months of diagnosis; Every 3-6 months during first year; Every 6-12 months thereafter based on disease activity; More frequent for anti-RNA polymerase III positive patients; Increased frequency if new symptoms develop; Annual comprehensive reassessment recommended
- Complementary Testing: Repeat scleroderma panel if diagnosis uncertain; Extended autoimmune serology if overlap features present; Testing for other connective tissue disease markers; Genetic testing for predisposition in familial cases; Skin biopsy if clinical diagnosis uncertain
Section 6: Fasting Required?
- Fasting Requirement: NO - Fasting is NOT required for the Scleroderma Panel. This is a serological antibody test that is not affected by food intake or glucose levels.
- General Preparation: Patients may eat and drink normally before the test; No dietary restrictions necessary; Patient can take regular medications as prescribed; Adequate hydration is beneficial to facilitate blood draw; Wear comfortable, loose-fitting sleeve to facilitate venipuncture
- Pre-Test Instructions: Avoid strenuous exercise for 24 hours before testing if possible; Inform phlebotomist of any bleeding disorders or anticoagulant use; Avoid caffeine/stimulants if concerned about anxiety during blood draw; Arrive well-rested if possible; Inform healthcare provider of recent immunizations or infections
- Medications and Supplements: No medications need to be withheld for this test; Continue all regular medications as prescribed; Immunosuppressive therapy does NOT need to be discontinued; Continue corticosteroids or DMARDs as normal; Anticoagulants should be noted but do not affect antibody results; NSAIDs may be taken as usual; Inform laboratory of all medications being taken
- Special Considerations: For patients on anticoagulants: Apply pressure to venipuncture site for extended time; For pregnant patients: Testing is safe throughout pregnancy; Recent transfusions should be noted (may affect some autoimmune markers); Active infections may transiently elevate some inflammatory markers; Recent vaccinations should be documented; Timing of specimens: morning or afternoon timing does not affect results
- Collection and Handling: Usually requires 5-10 mL of venous blood; Standard serum separator tube (SST) or specific tube per laboratory protocol; Specimen should be transported promptly to laboratory; Serum must be separated if SST used; Some tests may require frozen serum if delayed processing; Room temperature storage acceptable for most antibody tests; Specimens remain stable for several days at 2-8°C

How our test process works!