Two point-of-care tests for invasive aspergillosis launched

Submitted by BethBradshaw on 21 June 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 released point-of-care tests for invasive aspergillosis, which 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 result in less than an hour. Tests are performed individually rather than in batches, further reducing the time required.

  •            ISCA Diagnostics developed an Aspergillus LFA for diagnosis of invasive pulmonary aspergillosis that is available to purchase via OLM Diagnostics. OLM Diagnostics also produces an accompanying qPCR and galactomannan ELISA for confirming the diagnosis of aspergillosis.

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.

·         Read a review on LFAs in invasive aspergillosis testing by Helft and Hoenigl (2017).

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