Traditional ELISA Testing Testing for Invasive Aspergillosis is often performed by automated Enzyme ImmunoAssays (EIA), as this provides high throughput and economy of scale in reagent and staffing costs. Bronchoalveolar Lavage (BAL) fluid or serum samples can be batched and tested for the presence of Galactomannan (GM) on automated systems (such as the Dynex DS2®), in a 96well plate format. Optimal efficiency and economy of scale is achieved when a full 96-well plate is processed, as relatively fewer controls are run. However, reduced efficiency is achieved when fewer 8-well strips are processed at a time, and processing of incomplete strips causes important increases in test costs, as wells (i.e. tests) are wasted. Delays in Diagnosis Clearly, optimal processing of samples requires sufficient samples to fill strips or plates, which isn’t always the case in many laboratories. Batching of samples allows optimisation of laboratory efficiency but can cause delays in testing, which has important clinical impact. Moreover, laboratories that send samples to external laboratories for GM testing incur significant delays in result reporting. Importantly though, patients with invasive fungal infections require rapid and appropriate therapy. Hence, detection and identification of the causative organism should be achieved as quickly as possible. Rapid Testing One strategy to expedite GM testing is to test BAL and serum samples on a STAT basis, although, as discussed, this can lead to important cost implications for the laboratory if using an EIA. For laboratories processing lower numbers of specimens, a solution to this problem is to employ a Lateral Flow Assay (LFA) such as the IMMY sōna Aspergillus Galactomannan LFA (IMMY; Norman, USA). The IMMY sōna Aspergillus Galactomannan LFA has been suggested as a diagnostic tool in the 2020 ECMM CAPAIAA-ICU management algorithm guidelines1. Multiple studies have also demonstrated equivalent or even greater clinical performance of the assay than that of EIAs [Table 1]. IMMY sōna Aspergillus Lateral Flow Assay Improve your Laboratory Efficiency for Diagnosis of Invasive Aspergillosis Nick Parham, Senior Product Manager, Alpha Laboratories Ltd. Performance of IMMY ASP LFA Specimen Sensitivity Specificity NPV vs. Proven IA2 Serum & BAL 100% 95.5% vs. Probable IA2 Serum & BAL 87.5% 96.2% vs. Proven IPA3 BAL 91% 92% 99% vs. EORTC/MSG4 Serum 91% 91% vs. 2008 EORTC/MSG5 BAL 88% 81% 94% vs. EORTC excluding GM5 BAL 100% 81% 96% vs. AspICU5 BAL 94% 81% 97% vs. modified AspICU5 BAL 87% 81% 94% vs. modified AspICU excluding GM5 BAL 97% 81% 98% Table 1 : Good agreement to existing product, better agreement to EORTC (true disease status) 10 Leading Edge
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