ANAlyzeR™ ANA, IFA with Reflex Titer/Pattern, Systemic Autoimmune Panel 1

Message

Order as a MISC 36378

For Titer, order MISC test VDSFQ (MAYO CLINIC)

Test Code

36378

Quest Code

36378

Alias/See Also

36378

CPT Codes
86038, 86255, 86235 (x9), 86160 (x2), 86147 (x3), 86146 (x3), 83520 (x4), 86200, 86376

Includes

ANA Screen,IFA, with Reflex to Titer and Pattern
DNA (ds) Antibody, Crithidia IFA with Reflex to Titer
Chromatin (Nucleosomal) Antibody
Sm Antibody
Sm/RNP Antibody
RNP Antibody
Sjogren's Antibodies (SS-A, SS-B)
Scleroderma Antibody (Scl-70)
Jo-1 Antibody
Centromere B Antibody
Complement Component C3c and C4c
Cardiolipin Antibodies (IgA, IgG, IgM)
Beta-2-Glycoprotein I Antibodies (IgG, IgA, IgM)
Rheumatoid Factor (IgA, IgG, IgM)
Cyclic Citrullinated Peptide (CCP) Antibody (IgG)
Mutated Citrullinated Vimentin (MCV) Antibody
Thyroid Peroxidase Antibodies (TPO)

If ANA Screen, IFA is positive, then ANA Titer and Pattern will be performed at an additional charge (CPT code(s): 86039).

If the DNA (ds) Antibody Screen is positive, then DNA (ds) Antibody Titer will be performed at an additional charge (CPT code(s): 86256).

Preferred Specimen

9 mL serum collected in red-top tubes (no gel)

Patient Preparation
Overnight fasting is preferred

Minimum Volume

6 ml serum collected in a red-top tube (no gel)

Instructions

Draw blood in red-top tubes (no gel) to yield 9 mL of serum. Allow the blood to clot for at least 30 minutes, but not longer than 1 hour before centrifugation. Centrifuge each tube for 15 minutes at 1250 to 1600 RCF. Transfer serum to transport tube(s) and place on cold packs or refrigerator. Sample is stable 4 days at 2-8°C (refrigerated).

Transport Container

Transport tubes

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: Unacceptable
Refrigerated: 4 days
Frozen: 21 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Gross hemolysis • Grossly lipemic • Grossly icteric • Serum separator tubes (SST) • Heat treated samples

Methodology
See individual tests

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up and Report available: See individual assays

Reference Range

See Laboratory Report

Clinical Significance

This panel can be helpful in the diagnosis of systemic rheumatic disorders and other autoimmune diseases. Although the test for antinuclear antibodies (ANA) is strongly associated with systemic lupus erythematosus (SLE), the laboratory evaluation for individuals with clinical suspicion of a variety of autoimmune diseases often begins with an ANA screen. This panel simultaneously tests for ANA (using immunofluorescence) as well as the important specific autoantibodies associated with a positive ANA. It also includes testing for complement proteins, rheumatoid arthritis, Sjogren's syndrome, systemic sclerosis, polymyositis, anti-phospholipid antibody syndrome, and autoimmune thyroid disease.

Performing Laboratory
Quest Diagnostics Nichols Inst San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130

Last Updated: October 5, 2022

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.