Two point-of-care tests for invasive aspergillosis launched
June 21 2018
Prompt initiation of antifungal therapy can make the difference between life and death for patients with invasive aspergillosis, but symptoms such as unexplained fever are often non-specific and sending samples to the pathology lab for identification can take hours or days. Point-of-care diagnostics (or ‘bedside testing’) allows clinicians to start the correct treatment right away while awaiting the results of culture and histological examination. This is expected to be particularly useful in settings where patients are immunosuppressed (transplants, cancer, HIV/AIDS) or in critical care wards where patients may deteriorate quickly.
Two companies have now launched point-of-care tests for invasive aspergillosis. Both tests detect Aspergillus cell wall antigens in serum or BAL samples using a lateral flow assay (LFA). Affordable and simple to use, a small amount of sample is applied to a strip containing Aspergillus-specific antibodies. Just like a home pregnancy test, the appearance of control and test lines give a clear and rapid result. Tests are performed individually rather than in batches, further reducing the time to diagnosis.
- IMMY has released the sōna Aspergillus galactomannan LFA for diagnosis of invasive aspergillosis. Results are delivered in 30 minutes. IMMY already produces LFAs for the yeasts Cryptococcus neoformans/gattii and Coccidioides spp. Read the information leaflet
- The AspLFD is available to purchase from OLM Diagnostics, which uses the JF5 antibody (developed by ISCA Diagnostics) for diagnosis of invasive pulmonary aspergillosis. Accompanying tests to confirm the diagnosis include the AspID multiplex PCR kit (from OLM Diagnostics) and a galactomannan ELISA based on the same JF5 antibody (from EUROIMMUN).
Non-invasive LFAs are also on the horizon: MycoMed Technologies recently published a validation study of a POC urine dipstick, based on detection of small galactofuranose-containing antigens from Aspergillus conidia. It is hoped that the 510(k) premarket submission to the FDA will happen before the end of 2018.