Lupus Industry Council Study Finds Inconsistency of ANA Tests

A new study funded by the Lupus Research Alliance Lupus Industry Council shows that not all individuals who have been diagnosed with lupus remain positive for antinuclear antibodies (ANA) despite the long-held scientific belief to the contrary. Importantly, this study also reveals that whether a person with long-standing lupus tests ANA positive or negative can vary widely depending on the particular ANA test being used.

Using five different tests to detect antinuclear antibodies in blood serum samples from 103 people with confirmed lupus, study investigators found widely varying negative results ranging from 5% to 22%.

These findings have implications for identifying patients eligible for clinical trials as well as what treatment is recommended and raise important questions about the natural history of disease progression in individuals with established lupus.

Authors noted that given the range of differing results, “the findings raise questions about whether ANA positivity should be employed to determine eligibility for clinical trials.” It also could influence whether a treatment that gains approval for people with positive ANA could be reimbursed for individuals with long-standing lupus who are currently ANA negative. The investigators call for clinical trials using ANA tests for screening to specify the kit used, especially for people with established lupus. They also called for future studies to learn why a person with established lupus would test negatively for ANA and whether a positive ANA test should be a criterion for this group to enter a clinical trial.

This study was published by David S. Pisetsky, MD, PhD, of Duke University, Durham, N.C., and his associates in Annals of the Rheumatic Diseases. The Lupus Research Alliance initiated the Lupus Industry Council to unify industry and academia to address common obstacles to lupus drug development