Clinical evaluation of the newly formatted lateral‐flow device for invasive pulmonary aspergillosis

Abstract

SummaryThe study evaluated the newly formatted Aspergillus-specific lateral-flow-device (LFD), and compared its performance to the original prototype "old" LFD test using

Point‐of‐care diagnosis of invasive aspergillosis in non‐neutropenic patients: Aspergillus Galactomannan Lateral Flow Assay versus Aspergillus‐specific Lateral Flow Device test in bronchoalveolar lavage

“…In contrast, a recent smaller study reported markedly higher sensitivities (78%‐89%) and specificities (88%‐100%) for both the LFD and the LFA in patients with haematological malignancies, where better definitions of IPA exist. Overall sensitivity and specificity observed in this study were below those published for the LFD prototype test in comparable patient collectives, which was surprising, given that the newly formatted LFD was previously shown to be equally sensitive but more specific than the prototype . Importantly, when the LFA and LFD were combined, sensitivity increased to 81% while specificity remained just above 60%, making this a reasonable approach in patients with high clinical suspicion of IPA.…”

“…Given the absence of widely accepted criteria for defining IPA in non‐neutropenic patients, studies on new diagnostic tests for IPA focus mostly on patients with underlying haematological malignancies, where broadly accepted classification criteria exist, while diagnostic studies in non‐neutropenic patients are scarce. Importantly, two novel point‐of‐care diagnostic tests, both European conformity (CE) marked for diagnosis of IPA in BALF, have recently become commercially available, but to date have been only validated in patients with underlying haematological malignancies . These POC tests may allow earlier diagnosis and initiation of anti‐mould treatment compared to GM testing, given the longer and variable turnaround time of GM, and may thereby improve survival.…”

Global guidelines and initiatives from the European Confederation of Medical Mycology to improve patient care and research worldwide: New leadership is about working together

“…Moreover, new antifungal agents have recently become available or are being developed that warrant up‐to‐date guidance on optimal treatment of IFDs . Finally, the increasing availability of new nucleic acid amplification assays, blood culture detection systems, lateral flow devices, as well as matrix‐assisted laser desorption time of flight (MALDI‐TOF) mass spectrometry for detection of medically important fungi and laboratory diagnosis of invasive mycoses warrants guidance in their use in clinical practice …”

Real‐world challenges and unmet needs in the diagnosis and treatment of suspected invasive pulmonary aspergillosis in patients with haematological diseases: An illustrative case study

“…Importantly, the sensitivity of BAL GM is likely to have been overestimated in those studies since GM was used as a mycological criterion for defining probable IPA, which represented the majority of cases in those studies. The Aspergillus LFD in BAL samples shows a similar reduction in sensitivity to GM testing (56% sensitivity in treated patients vs 86% in untreated patients), and is therefore less reliable in patients receiving antimould prophylaxis or treatment . Mould‐active antifungal therapy also affects Aspergillus PCR monitoring of blood samples (specificity and sensitivity 52% and 50%, respectively, compared to 71% and 92% in drug‐naive patients) and BAL fluid samples .…”

“…Despite advances in the diagnostic arsenal, IPA remains difficult to diagnose. This is true in particular in patients receiving mould‐active prophylaxis or treatment, which has been shown to reduce sensitivity of all diagnostic tests for IPA …”