LFD-AsPaeds
Research type
Research Study
Full title
Evaluating the test performance of Aspergillus antigen detection using a lateral flow device (LFD) on broncho-alveolar lavage (BAL) fluid for the diagnosis of invasive pulmonary Aspergillosis in Paediatrics: A Pilot Study
IRAS ID
292170
Contact name
Laura Ferreras-Antolin
Contact email
Sponsor organisation
ST GEORGE'S UNIVERSITY HOSPITALS NHS FOUNDATION TRUST
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Invasive aspergillosis (IA) has high rates of mortality in immunocompromised children, such as those
with a primary immunodeficiency, haematological malignancy and children undergoing haematopoietic stem cell transplants (HSCT). IA is notoriously difficult to distinguish clinically from bacterial or mycobacterial disease. Prompt diagnosis of fungal disease leads to better outcomes for patients. Furthermore, safely stopping antifungal treatment early reduces toxicity and gives significant cost savings.Culture and tissue confirmation of Aspergillus spp. invasive growth are the gold standard for diagnosing proven IA. However, Aspergillus spp. are unreliably cultured from tissue and are rarely isolated from blood cultures. Hence, additional investigations are recommended by the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group
(EORTC): Computed Tomography (CT) of the chest and the use of Galactomannan (GM) antigen testing. But imaging and GM test have limitations in paediatrics. That is why, there is a need to develop more both accurate and rapid diagnostics with higher sensitivities and specificities.Currently there is a focus on lateral-flow devices (LFDs), which are point-of-care tests that can be read by the naked eye, allowing a diagnosis in 15 minutes. LFDs utilise the immunochromatographic monoclonal antibody that detects mannoproteins which are specific for Aspergillus spp. and produced during active growth. LFDs have given promising in the adult population, but there is no current published research into LFDs of BAL used to diagnose IA in paediatrics; being reasonable to suggest that the use of LFDs in the population may yield a rapid and accurate diagnosis in children too.
We are aiming to evaluate the use of LFDs children with cancer, who as part of their diagnostic workup undergo a BAL and assess whether the use of LFDs test adds to the diagnostic yield that we have with the standard methods already in place.
REC name
London - Hampstead Research Ethics Committee
REC reference
22/PR/0131
Date of REC Opinion
29 Mar 2022
REC opinion
Further Information Favourable Opinion