Suspected systemic lupus erythematosus (SLE) patients have long presented diagnostic challenges to front-line rheumatologists for a variety of reasons. Symptoms and signs of the disease are typically varied, with diagnostic criteria open for interpretation. Referring physicians and misinformation acquired over the Internet also can create confusion among patients themselves. With no single serologic test available, the diagnostic workup can be costly and time-consuming, and in the end, inconclusive.
More and more rheumatologists, however, are now employing a new blood test that has been validated to rule out SLE with 94% sensitivity, 75% specificity and a negative predictive value of 93%. These results, validated in a series of clinical trials, provide a high level of accuracy in the diagnosis of SLE.
SLE-Key Case Study
The case of Tanya Sullivan (not her real name), a 45-year-old Caucasian woman from Delaware, provides a typical illustration of how the SLE-Key test provided clarity to what had been a lengthy, uncertain and painful period of misdiagnosis and treatment.
Several years ago, Mrs. Sullivan woke up with severe pain throughout her body, pains that became so severe and debilitating that she had difficulty performing even the simplest tasks. Suspecting lupus, her primary care physician did a preliminary workup, which included an anti-nuclear antibody (ANA) test. When the test came back positive, she was referred to a local rheumatologist who subsequently diagnosed her with a “lupus-like” condition.
Following a period of treatment with Plaquenil and prednisone, with neither providing any relief, she sought help from a rheumatologist who reviewed her records and conducted his own physical examination, which found the following: (1) the patient was suffering from poorly controlled diabetes, a bipolar disorder and peripheral neuropathy in the feet and numerous tender points consistent with those found in fibromyalgia; (2) an ultrasonography with Doppler of her joints revealed no evidence of inflammatory synovitis; (3) a second ANA test came back positive; and (4) a nerve-conduction study confirmed the diabetic neuropathy in the feet as well as carpal tunnel syndrome in both hands.
Given these findings, the rheumatologist was suspicious of the previous diagnosis of lupus and ordered an SLE-Key test. The results of the test – now three years after the onset of her illness – all but confirmed that Mrs. Sullivan did not have lupus. As a result, she would not require treatment with immunosuppressant medications, but instead, her treatment plan focused on the treatment of fibromyalgia, neuropathic pain and carpal tunnel syndrome.
Had the SLE-Key test been available years ago to her primary care physician, the results could have assisted in preventing the now determined incorrect diagnosis, precluded the need for numerous blood tests (repeated by multiple physicians) and saved considerable time, money and mental anguish.