Using the SLE-keyÃÂ® Rule-Out Test in Clinical PracticeDonald Massenburg*, Justine Oldenberg, Amanda Sell, Tristan Krause and Alvin F. Wells
Rheumatology and Immunotherapy Center, Franklin, WI, USA
- *Corresponding Author:
- Donald Massenburg
Rheumatology and Immunotherapy Center
4225 Oakwood Park Court
Franklin, WI 53132, USA
Email: [email protected]
Received Date: April 10, 2017; Accepted Date: May 10, 2017; Published Date: May 26, 2017
Citation: Massenburg D, Oldenberg J, Sell A, Krause T, Wells AF (2017) Using the SLE-key® Rule-Out Test in Clinical Practice. Lupus Open Access 2:126.
Copyright: ©2017 Massenburg D, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Objectives: The patient referred to a rheumatology clinic for workup of suspected Systemic Lupus Erythematosus (SLE) often presents a difficult diagnostic problem; until recently, there have been no objective tests validated to rule in or rule out SLE and the diagnosis is based on a list of criteria that may be open to interpretation.
Methods: To approach this problem, a serologic rule out test for SLE was developed based on antigen microarray profiling of multiplex antibody reactivities. This SLE-key® test was developed by ImmunArray and, using stored serum samples from recognized academic centers, was validated to rule out SLE with 94% sensitivity, 75% specificity and a negative predictive value (NPV) of 93%. In clinical practice, however, patients are referred one at a time from peripheral clinical units, often with incomplete documentation.
Results: We report here the usefulness of the SLE-key® test in aiding the management of a cohort of suspected SLE patients in a large clinical rheumatology practice. We compared the diagnosis and disposition of 163 referrals in whom we used the SLE-key® Rule-Out test to our typical experience with referrals before the test was available. This paper shows that the SLE-key® test provided actionable clinical information and helped us with patient management in several ways; in some patients we were able to definitively rule out a diagnosis of SLE, saving time and evaluation costs; in other patients, we were able to accelerate the diagnosis of SLE and the initiation of therapy.
Conclusions: The SLE-key® Rule-Out test increased efficiency in saving undue concern, time and resources both to the patient and to the healthcare system.