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Test ID: ENA CENP
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ENA CENP
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Anti-centromere antibodies
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Useful For
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When a patient exhibits signs and symptoms of a connective tissue disease (CTD) and tests positive for antinuclear antibodies (ANA), clinical diagnosis is necessary. Furthermore, evaluating the patient for Extractable Nuclear Antigens Centromere (ENA Centromere) can aid in the clinical diagnosis of CREST syndrome, which includes symptoms such as calcinosis, Raynaud phenomenon, esophageal dysfunction, sclerodactyly, and telangiectasis.
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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-centromere antibodies
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Clinical information
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CENP antibodies are found in 70-90 % of patients with CREST Syndrome, a limited form of scleroderma with a comparatively favorable prognosis. However, they may also occur in Raynaud's phenomenon and primary biliary cirrhosis (about 10-20 %).
Most patients with limited scleroderma develop the features of CREST syndrome, which is characterized by calcinosis (subcutaneous calcific deposits), Raynaud's phenomenon, oesophageal dysmotility, sclerodactyly (thin, pale, sclerosed fingers) and telangiectasia (enduring dilatation of small superficial blood vessels).
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Aliases
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ENA CENP
ENA centromere
Anti-centromere
Autoantibodies to centromere
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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 Centromere 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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