Lupus Drug Induced Panel (Histone Antibody and ANA, IFA with Reflex)

Test Code

19874

CPT Codes
86038, 83516

Includes

ANA Screen, IFA, with Reflex to Titer and Pattern
Histone Antibodies

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

Preferred Specimen

2 mL serum

Minimum Volume

1 mL

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 24 hours
Refrigerated: 14 days
Frozen: 30 days

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

Gross hemolysis • Grossly lipemic • Microbial contamination may interfere

Methodology
Immunoassay (IA)

Setup Schedule

Set up and Report available: See individual tests

Reference Range

See individual tests

Clinical Significance

This panel can be helpful in the diagnosis of drug-induced lupus erythematosus (DILE) by simultaneously testing for antinuclear antibodies (ANAs) with an immunofluorescence assay (IFA), performed on human epithelial type 2 (HEp-2) cells, and histone antibody. For specimens with positive ANA IFA results, reflex testing for ANA titer and pattern is performed.

The laboratory evaluation for individuals with clinical suspicion of autoimmune diseases often begins with an ANA screen. The classic ANA IFA on HEp-2 cells is considered by the American College of Rheumatology (ACR) as the current gold standard because of its overall high sensitivity for several autoimmune diseases [1]. Knowing the ANA titer and fluorescent staining pattern can be helpful in interpreting positive results [2].

Although positive results for ANAs are usually needed for the diagnosis of DILE, the antibody profile mainly depends upon the inducing medication [3]. Histone antibody is reported to be present in over 90% of patients with DILE [3] but may not be induced as frequently by biologic agents, such as tumor necrosis factor inhibitor [4]. Therefore, a negative result for histone antibody does not rule out DILE. Moreover, histone antibody can also be detected in approximately 80% of patients with idiopathic systemic lupus erythematosus as well as in patients with a range of other conditions such as rheumatoid arthritis, mixed connective tissue disease, and autoimmune hepatic diseases [3,4]. Thus, a positive test result for histone antibody alone does not confirm the diagnosis of DILE.

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

Reference
1. Methodology of testing for antinuclear antibodies (position statement). 2009. American College of Rheumatology. Updated December 2019. Accessed May 15, 2023. https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/blta48818378bc89445/acr-position-statement-methodology-testing-antinuclear-antibodies.pdf
2. Tozzoli R, et al. Am J Clin Pathol. 2002;117(2):316-324.
3. Lee AYS. Immunol Med. 2022;1-6.
4. Kavanaugh A, et al. Arch Pathol Lab Med. 2000;124(1):71-81.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

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.