Test Code #

042

CPT Code(s) #

86038, 86039, 86255

Test Name

ANA Screen

If Profile, Includes Tests:

N/A

Disease Name:

Systemic Connective Tissue Disease

Type of Study:

Serum Studies

Methodology:

Indirect Immunofluorescence

Substrate:

HEp2

Reference Range:

• Negative <1:40

Units:

Titer

Schedule:

Assay performed once per week. Report availability is one week from the time of specimen receipt.

Specimen Requirements:

Collect 5-10 ml of blood in a red top or serum separator tube. If possible, separate serum from clot and place into red capped tube provided with Beutner Laboratories collection kits. If separation facilities are not available, the blood can be sent in the tube used for collection.

Sample Stability:

Stable at ambient temperature during shipment. If sample is stored prior to shipment, it is stable refrigerated (2-8ºC) up to five days and frozen (-20ºC or lower) up to one year.

Clinical Relevance:

"Antinuclear antibodies (ANAs) are a diverse group of autoantibodies that recognize nuclear macromolecules and their complexes. ANAs are associated with various rheumatic diseases, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), systemic sclerosis (SSc), primary Sjogren’s syndrome, and idiopathic inflammatory myopathies (IIMs). IIF on Hep-2 cells is considered the gold standard for screening for ANAs. ANA positivity with a titer of >/=80 is one of the diagnostic criteria for SLE. The interpretation of Hep-2 IIF results is dependent on the titer and pattern. A titer of 80 has a sensitivity of 98% and specificity of 75% for SLE diagnosis. The antibody pattern can sometimes provide useful information about the disease diagnosis. Positive Hep-2 IIF tests should be confirmed with disease-specific autoantibodies tests. ANA can be present in patients with non-rheumatic diseases and in healthy individuals. A nuclear fine dense fine speckled (DFS70) pattern on HEp-2 can sometimes be observed in 1-8% of healthy individuals. A negative test does not rule out diseases associated with certain antibodies such as SSA/Ro60, Ro52, ribosomal P, Jo1 and some IIM-associated autoantibodies.

References:

Bossuyt, X., De Langhe, E., Borghi, M. O., & Meroni, P. L. Understanding and interpreting antinuclear antibody tests in systemic rheumatic diseases. Nature Reviews Rheumatology. 2020; 16(12): 715-726"

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