We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

Download Mobile App




Urine-Based Assay Diagnoses Common Lung Infection in Immunocompromised People

By LabMedica International staff writers
Posted on 08 Aug 2025

Invasive Aspergillosis (IA), a life-threatening fungal infection, poses a serious threat to immunocompromised individuals, especially those with hematologic malignancies, transplants, or severe lung diseases. More...

Traditional IA diagnostic methods are invasive, costly, and slow, with limited sensitivity—often forcing clinicians to rely on broad-spectrum antifungal treatments. Global health agencies, including the WHO, have called for better diagnostic tools as drug resistance and toxicity rise. Now, a groundbreaking urine assay offers a non-invasive diagnostic approach for detecting IA

Pearl Diagnostics’ (Baltimore, MD, USA) MycoMEIA Aspergillus Assay is intended for aiding the diagnosis of IA. The test uses a microplate-based enzyme-linked immunoassay (ELISA) to detect biomarkers of the infection through a non-invasive urine sample. The assay leverages proprietary Smart Antibody technology to identify microbial extracellular vesicles.

The MycoMEIA assay underwent clinical validation at U.S. and European centers. Results showed that it offers higher sensitivity than current tests and can detect the disease earlier in its progression. With a sensitivity of approximately 90%, the tool also provides a strong negative predictive value—enabling clinicians to rule out IA confidently and avoid unnecessary treatments.

The MycoMEIA assay could lead to major improvements in care for at-risk patients, offering earlier intervention and reducing the toxic side effects from unnecessary antifungal use. The assay’s ability to reduce unnecessary medication use could also improve antifungal stewardship. The FDA has granted 510(k) clearance to the MycoMEIA assay, making it the first urine-based assay to receive FDA clearance as an aid to diagnose IA. The assay also carries a CE mark, indicating its potential for use in global clinical settings.

"The high negative predictive value of this assay should empower clinicians to withhold unnecessary antifungal therapies in severely ill patients," said Dr. Johan Maertens, Professor and Physician of Hematology, University Hospital Leuven. “Meanwhile, its sensitivity approximating 90% provides an excellent, non-invasive, and timely tool to diagnose invasive aspergillosis, the most common mold infection, in at-risk patients suspected of having this fungal disease.”

Related Links:
Pearl Diagnostics 


New
Gold Member
Automatic Hematology Analyzer
DH-800 Series
Portable Electronic Pipette
Mini 96
New
Gold Member
Auto Hematology Analyzer
DH-88CS [H]
Sample Transportation System
Tempus1800 Necto
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Hematology

view channel
Image: New evidence shows viscoelastic testing can improve assessment of blood clotting during postpartum hemorrhage (Photo courtesy of 123RF)

Viscoelastic Testing Could Improve Treatment of Maternal Hemorrhage

Postpartum hemorrhage, severe bleeding after childbirth, remains one of the leading causes of maternal mortality worldwide, yet many of these deaths are preventable. Standard care can be hindered by delays... Read more

Technology

view channel
Image: The SWITCH hybrid pipette is designed to simplify and accelerate pipetting tasks (Photo courtesy of INTEGRA)

Hybrid Pipette Combines Manual Control with Fast Electronic Aliquoting

Manual pipettes offer the control needed for delicate tasks such as mixing or supernatant removal, but typically fall short in repetitive workflows like aliquoting. Electronic pipettes solve this problem... Read more

Industry

view channel
Image: The partnership between OGT and QIAGEN unlocks a complete sample to report workflow for SureSeq NGS panels (Photo courtesy of OGT)

Qiagen and Oxford Gene Technology Partner on Sequencing Panel Interpretation

In clinical research, next-generation sequencing (NGS) panels provide essential insights for genetic analysis, but many laboratories face challenges in transforming raw sequencing data into clinically... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.