ANA by IFA, Reflex to 11-biomarker profile, by Multiplex Immunoassay*

Overview:

Use: Assay for screening for ANAs in patients suspected of having connective tissue disease. The indirect immunofluorescent test has three elements to consider in the result:

1. Positive or negative fluorescence. A negative test is strong evidence against a diagnosis of SLE but not conclusive.

2. The titer (dilution) to which fluorescence remains positive (provides a reflection of the concentration or avidity of the antibody). Many individuals, particularly the elderly, may have low titer ANA without significant disease substantiated after work-up.

3. The pattern of nuclear fluorescence (reflecting specificity for various diseases).

Cytoplasmic (non-nuclear) staining patterns may also be noted with the IFA methodology.

Multiplex ANA detects up to 11 specific antibodies of the 100+ antibodies that may be found in the ANA IFA.

Limitations: Males and females older than 80 years of age have a 50% incidence of low titer ANA. Various medications can induce a "lupoid" condition and elevated ANA titers. Usually the titer decreases following removal of the drug. Low antibody levels may be found in diseases other than connective tissue disease.

Methodology: Indirect Immunofluorescence Assay (IFA) and Multiplex Flow Immunoassay

If reflex test is performed, additional charges/CPT code(s) may apply.