Anti-Nuclear Antibodies, IgG (ANA)

CPT: 86038

Expected Turnaround Time

48 Hours

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Specimen Requirements

Specimen

Serum

Volume

5 ml

Minimum Volume

3 ml

Container

SST (Serum)

Storage Instructions

Room Temp., Refrigerated (2-8 C)

Stability Requirements

Room temp. 7 days, Refrigerated 7 days

Causes for Rejection

Mislabeled specimen, grossly hemolyzed specimen, sample collected expired tubes, clotted specimen

Test Details

Use

ANA Screen is intended for the qualitative screening of specific antinuclear antibodies (ANA). This test system is used as an aid in the diagnosis of systemic autoimmune diseases.

Methodology

Immunofluorescence assay (IFA)

Reference Interval

Negative

Additional Information

ANA Screen is intended for the qualitative screening of specific antinuclear antibodies (ANA). This test system is used as an aid in the diagnosis of systemic autoimmune diseases. The ANA Screen detects the presence of clinically relevant circulating autoantibodies in serum or plasma. These autoantibodies may be useful as an aid in the diagnosis of systemic autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Mixed Connective Tissue Disease (MCTD), Undifferentiated Connective Tissue Disease (UCTD), Sjögren’s Syndrome (SS), Scleroderma (Systemic Sclerosis), Dermatomyositis, Polymyositis, Rheumatoid Arthritis (RA), CREST Syndrome, and Raynaud’s Phenomenon.

References

  1. EM Tan. Autoantibodies in Diagnosis and in Identifying Antigens. The Immunologist 1999: 7 (3):
    85-92.
  2. A Kavanuagh, R Tomar, J Reveille, DH Solomon and HA Homburger. Guidelines for clinical use of the antinuclear antibody test and tests for specific autoantibodies to nuclear antigen. Arch Pathol Lab Med 2000; 124 (1): 71-81.
  3. R Tozzoli, N Bizzaro, E Tonutti, D Villalta, D Bassetti, F Manoni, A Piazza, M Pradella and P Rizzotti. Guidelines for the Laboratory Use of Autoantibody Tests in the Diagnosis and Monitoring of Autoimmune Rheumatic Diseases. Am J Clin Path 2002; 117(2): 316-24.
  4. M Golightly and C Golightly. Laboratory diagnosis of autoimmune diseases. Medical Lab Observer 2002(7); 12-20.

Footnotes

Statement on Medical Necessity
All ordered tests should be medically necessary for the diagnosis or detection of disease, illness, impairment, symptom, syndrome, or disorder and the results should be used in the medical management and treatment decisions for the patient. Solaris requires ICD-10 codes with each order for lab testing and both the tests ordered and the diagnosis should be documented in the provider’s medical record for the patient. The United States Department of Health and Human Services, Office of Inspector General, takes the position that a provider who orders medically unnecessary tests may be subject to civil penalties.

Panels and Profiles
Solaris offers Providers the convenience of ordering test combinations in a group at times with the flexibility to choose appropriate test(s) for individual patients. Providers should only order those tests that he or she believes are medically necessary for each patient, and a lesser inclusive profile or individual tests should be ordered if not all tests in the test combination/profile are medically necessary. All tests offered in a test combination/profile may be ordered separately as individual tests. Solaris encourages clients to contact their Solaris representative if the testing configurations shown do not meet individual needs for any reason, or if some other combination of procedures is needed.

CPT Codes
CPT Codes listed are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are the responsibility of the billing party and are listed here for informational purposes. Correct coding may vary from one carrier to another. Solaris may bill specific carriers using codes other than what is shown.

Questions?

For questions or inquiries related to testing please reach out to
customerservice@solarisdx.com or contact us by phone at (844) 550-0308.