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ANTINUCLEAR ANTIBODY by MULTIPLEX FLOW IMMUNOASSAY w/ REFLEX DISPLAY OF ANTIGENS
Message- ANA will automatically reflex to a panel only when positive.
- If the patient exhibits clinical signs and symptoms suggestive of a rheumatologic disorder and the Bioplex test is negative, repeat testing using an alternative method is recommended (IFA).
Test Code
ANABI
CPT Codes
86038; if reflexed add 86235 x10 and 86225
Includes
Includes: Quantitative detection of dsDNA; Semi-quantitative detection of Chromatin, Ribosomal P, SS-A, SS-B, Sm, SmRNP, RNP, Scl-70, Jo-1, and Centromere B
Preferred Specimen
1 Gold tube (gel separator)
Minimum Volume
0.5 mL
Other Acceptable Specimens
1 Lavender tube (EDTA) or
1 Green tube (Lithium Heparin)
1 Green tube (Lithium Heparin)
Instructions
Centrifuge for complete separation of plasma/serum and red cells. Separate and refrigerate until tested.
Transport Temperature
Refrigerate
Specimen Stability
2-8°C up to 7 days; otherwise freeze at -20° or lower
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Hemolyzed or lipemic samples will be rejected.
Methodology
Multiplex Flow Immunoassay
Setup Schedule
M, T, W, Th, F, Sa, Sun
Report Available
Within 24 hours of receipt at the performing laboratory.
Reference Range
Negative
Clinical Significance
This test utilizes a multiplex bead assay to assess the presence of antibodies associated with systemic autoimmune diseases which may be helpful in the diagnosis of: Rheumatoid arthritis (RA), systemic lupus erythematosus, scleroderma, mixed connective tissue disease, undifferentiated connective tissue disease, Sjogrens syndrome, dermatomyositis, polymyositis and Raynauds phenomenon. The test quantitatively detects dsDNA and qualitatively detects: chromatin, ribosomal P, SS-A 60, SS-A 52, SS-B, Sm, SmRNP, RNP A , RNP 68, Scl-70, Jo-1 and centromere B.
Proprietary software is used to report an association between the antibodies detected and systemic autoimmune disease. The test is intended for diagnostic use and is of limited clinical utility in monitoring disease course. Overlap may occur between antibodies and diseases. If a negative result is obtained in the presence of clinical signs and symptoms suggestive of systemic autoimmune disease, repeat testing using an alternative method is suggested (IFA). Positive results can be seen in apparently healthy individuals stressing the importance of clinical correlation with patient signs and symptoms. Patients with RA may demonstrate positivity in this assay with dsDNA and chromatin.
Proprietary software is used to report an association between the antibodies detected and systemic autoimmune disease. The test is intended for diagnostic use and is of limited clinical utility in monitoring disease course. Overlap may occur between antibodies and diseases. If a negative result is obtained in the presence of clinical signs and symptoms suggestive of systemic autoimmune disease, repeat testing using an alternative method is suggested (IFA). Positive results can be seen in apparently healthy individuals stressing the importance of clinical correlation with patient signs and symptoms. Patients with RA may demonstrate positivity in this assay with dsDNA and chromatin.
Performed By
Alverno Laboratories
Performing Laboratory
Alverno Central Lab
NIM5 (Immunology, Bioplex)
Last Updated: June 8, 2023
