June 16, 2022 -- The FDA has approved a new diagnostic blood test for lupus, which identifies the autoimmune disease by detecting a specific lupus-related antibody in people who are antinuclear antibody-negative, according to a recent update from the Lupus Foundation of America.

Antinuclear antibodies attack the body’s healthy cells, which is typically a hallmark of lupus, a connective tissue disease. Nearly all people with lupus -- or about 97% -- are antinuclear antibody-positive, the organization said, and doctors order an antinuclear antibody-positive blood test if they suspect a patient has lupus.

But a positive result from an antinuclear antibody-positive blood test isn’t typically enough to diagnose the disease, the foundation said. A small percentage of people with lupus are antinuclear antibody-negative, which means the new diagnostic test is “vitally important” for diagnosis in those patients.

Autoimmune diseases like lupus can be challenging to diagnose,” the organization said. “New, reliable test options can help healthcare providers identify the disease more quickly -- ultimately helping people with lupus get the treatment they need sooner and improving clinical outcomes.”

The biotechnology company Thermo Fisher Scientific Inc. developed the new test, called EliA Rib-P, to detect monospecific ribosomal P antibodies.

The test is designed with “optimal sensitivity and specificity” to support the diagnosis of systemic lupus erythematosus, which is the most common kind of lupus, the company said in an announcement.

“Autoimmune diseases can be a challenge to diagnose,” Henry Homburger, MD, professor emeritus of laboratory medicine at the Mayo Clinic College of Medicine and the laboratory director for the Thermo Fisher Phadia Immunology Reference Laboratory, said in the statement.

“Reliable and accurate laboratory tests that provide clinical clarity are essential tools for clinicians managing these patients,” he said.

Show Sources

Lupus Foundation of America: “New Blood Test Approved for Lupus Diagnosis.”

Thermo Fisher Scientific: “FDA Clears Thermo Scientific EliA RNA Pol III and EliA Rib-P Tests for Use in U.S.”

© 2022 WebMD, LLC. All rights reserved. View privacy policy and trust info