American Society for Clinical Pathology and American Society for Clinical Laboratory Science

View all recommendations from this society

November 7, 2022

Don’t order ANA and ENA unless the patient is suspected to have a connective tissue disease.

Testing for anti-nuclear antibody (ANA) and extractable nuclear antigen (ENA) should be avoided in the investigation of widespread pain or fatigue alone. Instead, testing should only be performed in patients suspected to have a diagnosis of a connective tissue disease (e.g., lupus, rheumatoid arthritis). ANA positivity can be as high as 20% in patients with non-rheumatic conditions and healthy individuals. For this reason, proper pre-test probability is important, and false positive results may lead to further unnecessary testing. Repeat testing is also not recommended unless the clinical picture changes significantly.


These items are provided solely for informational purposes and are not intended as a substitute for consultation with a medical professional. Patients with any specific questions about the items
on this list or their individual situation should consult their physician.

How The List Was Created

(1–4) The American Society for Clinical Pathology (ASCP) list of recommendations was developed under the leadership of the ASCP Effective Test Utilization Steering Committee. This committee is chaired by an ASCP Past President and is comprised of subject matter and test utilization experts across the fields of pathology and laboratory medicine. The committee considered a list of possible recommendations compiled as the result of a survey administered to Society members serving on ASCP’s many commissions, committees and councils. In addition, an announcement was made to ASCP’s Advisory Board seeking suggestions for possible recommendations to promote member involvement. The laboratory tests targeted in our recommendations were selected because they are tests that are performed frequently; there is evidence that the test either offers no benefit or is harmful; use of the test is costly and it does not provide higher quality care; and eliminating it or changing to another test is within the control of the clinician. Implementation of these recommendations will result in higher quality care, lower costs and a more effective use of our laboratory resources and personnel.

(5) This recommendation was developed under the leadership of ASCLS’s Choosing Wisely Committee and the ASCLS Board of Directors. The Committee examined numerous options based on evidence available. Subject matter experts from the ASCLS Scientific Assemblies reviewed, edited, and recommended approval of this recommendation, which was subsequently reviewed and approved by the ASCLS Board of Directors.

Sources

Tozzoli R, Bizzaro N, Tonutti E, Villalta D, Bassetti D, Manoni F, Piazza A, Pradella M, Rizzotti P; Italian Society of Laboratory Medicine Study Group on the Diagnosis of Autoimmune Diseases. 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):316-24. doi: 10.1309/Y5VF-C3DM-L8XV-U053. PMID: 11863229.

Solomon DH, Kavanaugh AJ, Schur PH; American College of Rheumatology Ad Hoc Committee on Immunologic Testing Guidelines. Evidence-based guidelines for the use of immunologic tests: antinuclear antibody testing. Arthritis Rheum. 2002 Aug;47(4):434-44. doi: 10.1002/art.10561. PMID: 12209492.

Ferrari R. Evaluation of the Canadian Rheumatology Association Choosing Wisely recommendation concerning anti-nuclear antibody (ANA) testing. Clin Rheumatol. 2015 Sep;34(9):1551-6. doi: 10.1007/s10067-015-2985-z. Epub 2015 Jun 2. PMID: 26032433.