Lupus Panel 4

Last Modified: 2/14/2024 12:07:14 PM


Medical Necessity Documentation:  
Client Notes:  
Patient Preparation: Overnight fasting is preferred
Specimen Requirements:

4.0 mL Serum from a Red Top Tube(s) in a Plastic Vial

Collection Instructions:  
Minimum Volume: 2.0 mL Serum
Transport & Storage: Temperature/Stability: Unacceptable Ambient
7 days Refrigerated (transport)
30 days Frozen
Rejection Criteria: Gross hemolysis • Grossly lipemic • Grossly icteric
Reference Range: See individual tests
Critical Ranges:  
Test Comments:

Methodology: Multiple - See Individual Tests
Clinical Significance:

This panel can be helpful in the diagnosis of systemic lupus erythematosus (SLE) and several other autoimmune diseases, including mixed connective tissue disease, Sjogren syndrome, systemic sclerosis, and autoimmune thyroid disease. The panel simultaneously tests for antinuclear antibodies (ANAs) with an immunofluorescence assay (IFA), performed on human epithelial type 2 (HEp-2) cells, and 11 biomarkers associated with these conditions. For specimens with positive ANA IFA results, reflex testing for ANA titer and pattern is performed.

The ANA testing has high sensitivity (97%) for SLE but limited specificity (34%) [1]. Thus, a positive ANA test does not exclude other autoimmune diseases with similar clinical features [2]. Testing for specific antibodies in a panel may expedite the evaluation of SLE but is generally not recommended [3].

The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings.

Documentation:  
Custom Panel: No

PRODUCTION SCHEDULE

Turn Around Time: 1 to 4 days
Days Performed: Monday, Tuesday, Wednesday, Thursday, Friday
Sites Performed: Quest - Chantilly
PHL Test Code: MSOT
EPIC Test Code:
Send Out Test Code: 36378
Alternate Test Names: ANAlyzer®; ANAlyzeR™ ANA, IFA with Reflex Titer/Pattern, Syst; Antinuclear Antibody Screen,Systemic Lupus Erythem; FANA; Fluorescent ANA; Lupus (12) Panel; Lupus Analyzer; Lupus Panel 4 with ANA, IFA with Reflex to Titer a; Progressive ANA,Hep-2; Thyroiditis
Included Tests: ANA Screen, IFA, with Reflex to Titer and Pattern; DNA (ds) Antibody; Complement Component C3c; Complement Component C3c and C4c; Complement Component C4c; Rheumatoid Factor; Scleroderma Antibody (Scl-70); Thyroid Peroxidase Antibodies (TPO); Ribosomal P Antibody; Sm Antibody; Sm/RNP Antibody; Sjogren's Antibody (SS-A); Sjogren's Antibody (SS-B); 
CPT Coding: 83516, 86038, 86160 (x2), 86225, 86235 (x5), 86376, 86431 - If the ANA Screen, IFA is positive, then ANA Titer and Pattern will be performed at an additional charge (CPT code(s): 86039).

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