Some with Lupus may be Misclassified, Undiagnosed, and Overlooked for Clinical Trials due to Misleading Lab Reports
Recent research suggests that some people with lupus may be incorrectly classified as anti-nuclear antibody (ANA) negative. The ANA blood test is important in helping healthcare providers make an accurate diagnosis of the disease, and under new guidelines, a positive ANA test is required for people with lupus to be considered for clinical trials. Among the 1,137 newly diagnosed people with SLE included in the study, 17 were misclassified as ANA-negative.
Not all lupus antibodies display nuclear patterns that show up in the common ANA testing method. Therefore, some relevant antibodies indicating the presence of SLE may not even be included in the final ANA lab reports. As a result, people who actually have lupus may be overlooked, go undiagnosed, or may not qualify for clinical trials.
Lead investigator May Choi, MD, FRCPC, rheumatology clinical lecturer at the Cumming School of Medicine, University of Calgary, and Alberta Health Services, Canada, and recipient of a Lupus Foundation of America (LFA) Gary S. Gilkeson Career Development Award, adds, “A lack of diagnostic, predictive, and prognostic biomarkers for clinical care and drug development remains one of the top barriers hindering the advancement of SLE management. Therefore, a more concerted and longitudinal effort to identify and validate biomarkers such as the ANA test is needed."
The authors predict that lupus testing and definitions will change in the future as we learn more about the disease and its diagnosis. Getting an early diagnosis of lupus is critical to preventing long-term consequences of the disease. Unfortunately, there isn’t just one diagnostic test doctors can use. That’s why the LFA has funded research to explore measuring levels of a specific protein in the blood, called C4d, which might be a more useful way to diagnose and monitor lupus compared to other methods available. Learn about a new blood test that can help doctors diagnose lupus.