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Can Test-Ordering Guidelines Improve Diagnostic Accuracy?

Lisa A. Mandl, MD, MPH; Daniel H. Solomon, MD, MPH; Ellison L. Smith, MD; Robert A. Lew, PhD; Jeffrey N. Katz, MD, MS; Robert H. Shmerling, MD

Arch Intern Med. 2002;162:1509-1514.

Background  Antineutrophil cytoplasmic antibodies (ANCAs) are strongly associated with Wegener granulomatosis, Churg-Strauss angiitis, microscopic polyangiitis, and pauci-immune glomerulonephritis, referred to collectively as ANCA-associated vasculitis (AAVs). It is unclear how accurate ANCA measurement is for diagnosing AAV in diverse populations or whether proposed ANCA test-ordering guidelines improve test performance.

Methods  We assembled a retrospective case series of hospitalized and ambulatory patients from 2 academic medical centers to assess the diagnostic accuracy of ANCA measurement by enzyme-linked immunosorbent assay in identifying cases of AAV. In addition, we assessed the effect of applying proposed ANCA test-ordering guidelines on test performance.

Results  For ANCA testing, sensitivity was 81%; specificity, 98%; positive predictive value, 54%; and negative predictive value, 99%. There were no significant changes in operating characteristics after applying the guideline criteria. Using guidelines would have decreased ANCA test ordering by 23% and would have decreased the false-positive rate by 27%. No cases of AAV would have been missed if only patients fulfilling the guidelines were ANCA tested.

Conclusion  A positive result on an enzyme-linked immunosorbent assay ANCA test, as it is currently ordered, is not a definitive diagnostic indicator of AAV. Compliance with guidelines for ANCA testing would decrease the number of false-positive results and has the potential to reduce total test expenditures.

From the Robert B. Brigham Multipurpose Arthritis and Musculoskeletal Disease Center, Boston, Mass (Drs Mandl, Solomon, Smith, Lew, and Katz); the Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, Boston (Drs Mandl, Solomon, and Katz); and the Divisions of General Medicine and Primary Care (Dr Shmerling) and Rheumatology (Drs Smith and Shmerling), Beth Israel Deaconess Medical Center, Boston. Dr Smith is now with the Asheville Arthritis Center, Asheville, NC.

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