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Antinuclear Antibodies (ANA), by Multiplex Immunoassay, Reflex to 5-biomarker profile (ENA), dsDNA, RNP, Sm, SS-A, SS-B
CPT:
86038
Synonyms
- ANA With Reflex
- ANA-specific Antibodies
- Extractable Nuclear Antibodies
Test Includes
Antinuclear antibodies (ANA) will reflex if positive to dsDNA; RNP; Sjögren's A; Sjögren's B; Smith (Sm). If reflex testing is performed, additional charges/CPT code(s) may apply.
Expected Turnaround Time
2 - 3 days
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.
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2 - 3 days |
Related Documents
Specimen Requirements
Specimen
Serum
Volume
1 mL
Minimum Volume
0.5 mL (Note: This volume does not allow for repeat testing.)
Container
Red-top tube or gel-barrier tube
Storage Instructions
Room temperature
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 14 days |
Refrigerated | 14 days |
Frozen | 14 days |
Freeze/thaw cycles | Stable x3 |
Causes for Rejection
Hemolysis; lipemia; gross bacterial contamination; icterus
Test Details
Methodology
Multiplex flow immunoassay
References
Astion ML, Wener MH, Hutchinson K. Autoantibody testing: The use of immunofluorescence and other assays. Clin Lab News. 2000; (7):30-34.
Berner ES, Webster GD, Shugerman AA, et al. Performance of four computer-based diagnostic systems. N Engl J Med. 1994 Jun 23; 330(25):1792-1796. 8190157
Centers for Disease Control and Prevention. Manual Guide—Safety Management N° CDC-22 Decontamination of Laboratory Sink Drains to Remove Azide Salts. Atlanta, Ga: CDC; April 30, 1976.
Eriksson C, Engstrand S, Sundqvist KG, Rantapää-Dahlqvist S. Autoantibody formation in patients with rheumatoid arthritis treated with anti-TNF alpha. Ann Rheum Dis. 2005 Mar; 64(3):403-407. 15297281
Fulton RJ, McDade RL, Smith PL, Kienker LJ, Kettman JR Jr. Advanced multiplexed analysis with the FlowMetrix system. Clin Chem. 1997 Sep; 43(9):1749-1756. 9299971
Golightly M, Golightly C. Laboratory diagnosis of autoimmune diseases. MLO Med Lab Obs. 2002 Jul; 34(7):12-16, 20. 12134551
Homburger HA, Cahen YD, Griffiths J, Jacob GL. Detection of antinuclear antibodies: Comparative evaluation of enzyme immunoassay and indirect immunofluorescence methods. Arch Pathol Lab Med. 1998 Nov; 122(11):993-999. 9822128
Isenberg DA. Systemic lupus erythematosus and Sjögren's syndrome: Historical perspective and ongoing concerns. Arthritis Rheum. 2004 Mar; 50(3):681-683. 15022304
Kallenberg CG, Wouda AA, Hoet MH, van Venrooij WJ. Development of connective tissue disease in patients presenting with Raynaud's phenomenon: A six year follow-up with emphasis on the predictive value of antinuclear antibodies as detected by immunoblotting. Ann Rheum Dis. 1988 Aug; 47(8):634-641. 3261966
Kavanaugh A, Tomar R, Reveille J, Solomon DH, Homburger HA. Guidelines for clinical use of the antinuclear antibody test and tests for specific autoantibodies to nuclear antigens. American College of Pathologists. Arch Pathol Lab Med. 2000 Jan; 124(1):71-81. 10629135
Narain S, Richards HB, Satoh M, et al. Diagnostic accuracy for lupus and other systemic autoimmune diseases in the primary care setting. Arch Intern Med. 2004 Dec 13-27; 164(22):2435-2441. 15596633
Phan TG, Wong RC, Adelstein S. Autoantibodies to extractable nuclear antigens: Making detection and interpretation more meaningful. Clin Diagn Lab Immunol. 2002 Jan; 9:(1):1-7. 11777822
Reeves WH, Satoh M. Autoantibodies in systemic lupus erythematosus. In: Koopman WJ, ed, Arthritis and Allied Conditions: A Textbook of Rheumatology. 14th ed. Philadelphia, Pa: Lippincott, Williams and Wilkins; 2001:1483.
Reichlin M, Harley JB. Antinuclear antibodies: An overview. In: Wallace DJ, Hahn BH, eds. Dubois Lupus Erythematosus. 5th ed. Baltimore, Md: Williams and Wilkins;1997:403.
Reisner BS, DiBlasi J, Goel N. Comparison of an enzyme immunoassay to an indirect fluorescent immunoassay for the detection of antinuclear antibodies. Am J Clin Pathol. 1999 Apr; 111(4):503-506. 10191770
Rekvig OP, Kalaaji M, Nossent H. Anti-DNA antibody subpopulations and lupus nephritis. Autoimmun Rev. 2004 Feb; 3(2):1-6. 15003181
Simón JA, Cabiedes J, Ortiz E, Alcocer-Varela J, Sánchez-Guerrero J. Anti-nucleosome antibodies in patients with systemic lupus erythematosus of recent onset. Potential utility as a diagnostic tool and disease activity marker. Rheumatology (Oxford). 2004 Feb; 43(2):220-224. 13130152
Sturgess A, Edmonds J. Improving the effectiveness of autoantibody testing in the clinic. Autoimmun Rev. 2002 Oct; 1(5):273-278. 12848980
Tan EM. Autoantibodies in diagnosis and in identifying antigens. Immunologist. 1999; 7(3):85-92.
Tan EM, Smolen JS, McDougal JS, et al. A critical evaluation of enzyme immunoassays for detection of antinuclear autoantibodies of defined specificities. I. Precision, sensitivity, and specificity. Arthritis Rheum. 1999 Mar; 42(3):455-464. 10088768
Tozzoli R, Bizzaro N, Tonutti E, et al. Guidelines for the laboratory use of autoantibody tests in the diagnosis and monitoring of autoimmune rheumatic diseases. Am J Clin Pathol. 2002 Feb; 117(2):316-334. 11863229
Zlatkis A, Lee KY, Poole CF, Holzer G. Capillary column gas chromatographic profile analysis of volatile compounds in sera of normal and virus-infected patients. J Chromatogr. 1979 Jun 11; 163(2):125-133. 541363
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 164962 | ANA w/Reflex | 8061-4 | 164862 | ANA Direct | 8061-4 |
| Reflex Table for ANA Direct | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 016123 | ENA+DNA/DS+Sjogren's | 096343 | Anti-DNA (DS) Ab Qn | IU/mL | 5130-0 |
| Reflex Table for ANA Direct | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 016123 | ENA+DNA/DS+Sjogren's | 016354 | RNP Antibodies | AI | 29374-6 |
| Reflex Table for ANA Direct | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 016123 | ENA+DNA/DS+Sjogren's | 016362 | Smith Antibodies | AI | 11090-8 |
| Reflex Table for ANA Direct | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 016123 | ENA+DNA/DS+Sjogren's | 012684 | Sjogren's Anti-SS-A | AI | 17792-3 |
| Reflex Table for ANA Direct | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 016123 | ENA+DNA/DS+Sjogren's | 012692 | Sjogren's Anti-SS-B | AI | 17791-5 |
| Reflex Table for ANA Direct | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 016123 | ENA+DNA/DS+Sjogren's | 164869 | See below: | n/a | |
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