Rapid Urine Test Aids Diagnosis of Invasive Aspergillosis

Diagnosis can be difficult because existing approaches may require chest imaging, blood testing, bronchoscopy-based respiratory sampling, or tissue biopsy, and some methods are invasive or inconclusive. To support less invasive diagnosis, researchers now present clinical data for a rapid urine-based assay designed to aid detection of the condition.

Johns Hopkins Medicine (Baltimore, MD, USA) investigators evaluated a rapid urine-based assay for invasive aspergillosis that was cleared by the FDA in late 2025 for use in adults with suspected disease. The assay is intended to be used with clinical findings, imaging and other laboratory tests. It directly detects Aspergillus antigens in urine and can provide a laboratory result within several hours.

The investigators assessed the assay’s ability to detect Aspergillus galactofuranose-containing antigens, described as proteins signaling the body’s response to the infection. They analyzed frozen urine samples from 290 study participants enrolled in studies in the United States and Belgium between 2009 and 2022. Among these participants, 50 had confirmed invasive aspergillosis and 240 served as controls. The urine samples were tested at laboratories in Baltimore, Pittsburgh and Raleigh.

In the frozen-sample analysis, the assay correctly identified 46 of 50 confirmed invasive aspergillosis cases, or 92%, with four false negative results. It also correctly identified 218 of 249 samples as negative, or 88%. A second assessment examined patients suspected to have invasive aspergillosis at The Johns Hopkins Hospital between January 2023 and February 2024. Of 210 participants who provided samples, 168 were eligible for analysis, and 171 fresh urine samples were analyzed in real time; the assay identified 6 of 7 positive cases, or 86%, and 35 of 39 negative cases, or 90%.

The data were published in Clinical Infectious Diseases on October 7, 2026. The investigators are also studying how the assay performs when incorporated into routine clinical care. Additional work is evaluating whether it may provide value in other high-risk settings, including among immunocompromised patients assessed for fungal complications after respiratory viral infections.

“For patients with blood cancers or stem cell transplants, the hardest part is often the gap between suspecting invasive aspergillosis and having enough evidence to act. This urine test is not a stand-alone answer, but it can provide another piece of evidence quickly and noninvasively, which could help us move faster for patients most likely to benefit from treatment while avoiding unnecessary antifungal exposure when infection is less likely,” said Nitipong Permpalung, M.D., M.P.H., director of mycology research and associate director for clinical trials at the Johns Hopkins Transplant Research Center.

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