Test ID: ENA Scl-70
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ENA Scl-70
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Anti- Scl-70/anti-topoisomerase antibodies
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Useful For
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When the test for antinuclear antibodies (ANA) is positive, clinical diagnosis of patients with signs and symptoms of a connective tissue disease (CTD) is necessary. Additionally, evaluating the patient for Extractable Nuclear Antigens Scl70 (ENA Scl70) can aid in the clinical diagnosis of scleroderma (diffuse form).
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Method name and description
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Method: Fluorescence Enzyme Immunoassay (FEIA), Uses the EliA IgG method on Phadia system.
Using EliA technology solid phase, analyte molecules can be extracted from a sample. To achieve this, a well is coated with an antigen that specifically binds to target antibodies. Following the removal of non-bound antibodies, enzyme-labeled antibodies against human antibodies (EliA IgG Conjugate) are added to form an antibody conjugate complex. This complex is then incubated and non-bound conjugate is subsequently washed away. The bound complex is then incubated with a Development Solution, and after stopping the reaction, the fluorescence in the reaction mixture is measured. A higher response value indicates the presence of a more specific antibody in the specimen.
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Reporting name
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Anti- Scl-70/anti-topoisomerase antibodies
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Clinical information
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Determining the presence of antinuclear antibodies (ANA) is crucial for clinically diagnosing connective tissue diseases. The presence of antibodies against Scl-70 is specific and characteristic for scleroderma, particularly the diffuse form, with a frequency of up to 70%. Scleroderma, or systemic sclerosis (SSc), is a chronic and progressive dermatosis that results in the hardening and immobility of affected skin, with potential involvement of vital organs such as the lungs, esophagus, kidneys, and heart.
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Aliases
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ENA Scl-70
Scleroderma-70
Anti- Scl-70/anti-topoisomerase antibodies
Anti Scl-70
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Specimen type / Specimen volume / Specimen container
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Specimen type: Serum sample.
Specimen Volume: At minimum 2 mL whole blood or 0.5 mL serum.
Container Tube: Plan tube /Serum gel (Yellow top tubes).
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Storage and transport instructions
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For sample transportation, the sample should remain at room temperature (18-25°C ) for no longer than eight hours.
Separated serum samples can be stored at 2-8°C for one week.
Separated serum samples should be frozen at below -20°C for any long-term storage.
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Specimen Rejection Criteria
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Quantity not sufficient (QNS)
Hemolysis
Lipemic
Wrong collection container
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Biological reference intervals and clinical decision values
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Anti-ENA Scl-70 antibodies:
Interpretation of Test Results |
Reference Values (U/ml) |
Negative |
< 7 |
Equivocal |
7 - 10 |
Positive |
> 10 |
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Turnaround time / Days and times test performed / Specimen retention time
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Turnaround Time: 5 working days.
Days and Times test performed: Twice per week starting from Sunday through Thursday from 7:00 to 15:00.
Specimen retention time: Approximately 7 days.
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