Point-of-care tests in the diagnosis of aspergillosis
Research type
Research Study
Full title
Point-of-care tests in the diagnosis of chronic aspergillosis
IRAS ID
250683
Contact name
Chris Kosmidis
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Chronic pulmonary aspergillosis (CPA) is an increasingly recognised global health problem affecting people with TB or other chronic lung disease. It is often diagnosed late, when significant lung destruction has already progressed.\n\nIn high-income settings where TB is less common, such as the UK, CPA mainly affects patients with chronic respiratory disease like COPD or bronchiectasis. The diagnosis is made by bronchoscopy and testing of bronchoalveolar lavage fluid for Aspergillus in the setting of a compatible chest CT scan (usually showing cavities or nodules); however, the tests are neither sensitive nor specific. Sensitivity of culture is poor, and molecular tests are used, like PCR or galactomannan. Turn around time, even for specialised labs, may be long and cost of the tests is high. A less costly point of care (POC) test for diagnosis of Aspergillus from pulmonary secretions would speed up diagnosis in this setting and allow prompt treatment initiation. We plan to compare two recently developed POC tests with the conventional methods for the diagnosis of CPA in patients having bronchoscopies where CPA is in the differential diagnosis. To assess fungal detection performance, we will use as the gold standard a new technology to analyse the entire population of fungi in the lung (called the mycobiome). \n\nThe Mycology Reference Centre Manchester receives approximately 10 bronchial lavage samples for galactomannan testing per month from Salford Royal NHS Foundation Trust and Wrightington, Wigan and Leigh NHS Foundation Trust. In collaboration with these patients’ clinical teams, it will be confirmed whether CPA is in the differential diagnosis. If this is the case, the samples will be tested with the two new point of care tests, provided enough left over sample is available after the routine clinical tests have already been performed.
REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0028
Date of REC Opinion
2 Mar 2020
REC opinion
Further Information Favourable Opinion