Verification of a galactomannan lateral flow assay on-site: a potential tool for developing - PowerPoint Presentation

1. Verification of a galactomannan lateral flow assay on-site: a potential tool for developing a diagnostic antifungal stewardship care bundleAnne O Hara (Senior Medical Scientist)Microbiology Department Beaumont HospitalDr Alida Fe Talento (C.H.I.), Dr Binu Dinesh, Dr Karina O Connell, Dr Sinead O’Donnell, Prof. Fidelma Fitzpatrick, Prof. Karen Burns, Ms Margaret Fitzpatrick.Contact details:anneohara@beaumont.ie

2. Background COVID-19-associated pulmonary aspergillosis (CAPA) is associated with significant morbidity. Availability of early diagnostic tests aids prompt treatment of suspected cases. Detection of galactomannan (GM) in serum or bronchoalveolar lavage fluid (BALF) is a mycological criteria of invasive pulmonary aspergillosis. During the first wave of SARS-CoV-2, we audited the management of patients with suspected CAPA in critical care and identified several areas for improvement. We found that the average turnaround time (TAT) for GM on BALF or serum samples was 10 days. Additionally these results were not accessible on the hospital computer system (BHIS and PIPE)Aim. Our aims were to provide a more rapid TAT for GM results by verifying a CE marked GM Lateral Flow Assay (LFA) on site for the detection of Aspergillus GM to facilitate appropriate antifungal therapy. have the results visible on BHIS and PIPE have the test accredited to ISO15189 standards.Change initiative Following successful verification (high level concordance with reference laboratory results) we have added the GM LFA to our laboratory repertoire (performed twice weekly) and have received Irish National Accreditation Board (INAB) accreditation for this assay.

3. PProblemLong TAT to detection. Results not accessible on hospital computer system (BHIS and PIPE)IInterventionVerify a CE marked GM LFA. Submit for INAB accreditation.CComparison GroupSamples (Sera and BALF) with known results from St James’s Hospital (SJH) and The Mycology Reference Laboratory Bristol (MRLB) n=57OOutcomesConfirm concordance with reference tests; Decrease TAT to detection of Aspergillus GM; Accessibility of results on the hospital computer system (BHIS and PIPE); Achieve INAB accreditation.Results: % concordance and discordance for all samples compared with SJH and MRLB. Results were read visually and using a digital Cube Reader*All discordant results were close to the cut off values (0.5 for sera and 1.0 for BALF) . Discordant results were with seraWhat worked well: Use of the Digital Cube Reader improved the % concordance, removed subjectivity of test and allows for a Galactomannan Index (GM) to be reported. This value is used to monitor patient treatmentConcordanceDiscordance*Visual Read (2 investigators)74%26%Digital Read out93%7%INAB accredited

4. Sustainability: Improvement will be sustained and standards assured by maintaining INAB accreditation to ISO 15189 standards. Value to patients: Significant decrease in TAT from an average of 10 days to same day results (maximum TAT of 3 days) which providesEarlier diagnosis of invasive pulmonary aspergillosis and initiation of appropriate antifungal therapyEarlier discontinuation of unnecessary antifungal therapyLess exposure to antifungal agents and the associated adverse effectsDecrease emergence of antifungal resistance Results are available on BHIS and PIPE as apposed to paper results from MRLB.Spread:This work has been presented at the Irish Society of Clinical Microbiologist national conference to the staff of the Microbiology Department of Beaumont Hospital as part CPD for CORUAdditional information: GM LFA has now been incorporated into a diagnostic care bundle which facilitates more timely diagnosis of invasive aspergillosis in COVID-19 and other patient cohorts, ultimately improving patient management.