Clinical Performance White PL., et al.6 evaluated the clinical performance of the IMMY sōna Aspergillus Lateral Flow Assay (AGM LFA) in serum samples from cases classified as proven/probable/chronic IA/ IFD (n=32) using EORTC/MSG criteria and control patients with no evidence of IFD (n=100). In serum samples, the AGM LFA was found to correctly generate a positive result for 97% of patients with IA, and a negative result for 98% of patients without IA. The PPV shows that among patients with a positive AGM LFA result, the probability that they truly have IA is 94%. NPV shows that among patients with a negative AGM LFA result, the probability that they do not have IA is 99%. Mercier T, et al.3 examined the diagnostic performance of the IMMY sōna Aspergillus Lateral Flow Assay in BAL samples from haematology patients classified as proven IPA (n=11) using EORTC/MSG criteria and control patients with no evidence of IPA (n=117). In BAL samples, the AGM LFA correctly generated a positive result for 91% of patients with IA, and a negative result for 92% of patients without IA. The NPV shows that among patients with a negative AGM LFA result, the probability that they do not have IA is 99%. With the IMMY sōna Aspergillus Lateral Flow Assay, results are produced in 45 minutes as opposed to 3½ hours with EIAs, which provides a rapid turnaround time (TAT) and reporting of results to clinicians, who can then manage their patients appropriately. Confirmatory Testing For laboratories processing sufficient samples to be able to use EIAs efficiently, there is still a case for using an LFA. This is because positive GM EIA results often require confirmatory testing, which is generally done immediately as further delays in result reporting, due to batching of these samples, cannot be accepted. If this is done with an EIA, testing efficiency is usually reduced due to incomplete filling of test strips. Also, TAT is extended as around 3½ hours are required to run the assay. As such, use of the IMMY sōna Aspergillus Lateral Flow Assay for immediate confirmatory testing of ASP GM EIA-positive samples improves laboratory efficiency, TAT, and facilitates expeditious treatment of patients. Further, due to its two unique monoclonal antibodies, the IMMY sōna Aspergillus Lateral Flow Assay provides additional specificity that can reduce the occurrence of false-positive results. For more information please visit: www.alphalabs.co.uk/aspergillus Sensitivity Specificity PPV NPV 97% 98% 94% 99% Sensitivity Specificity NPV 91% 92% 99% References: 1. ECMM. COVID-19/Influenza-Associated Pulmonary Aspergillosis – Management. 2020 2. Jani K, McMillen T, Morjaria S, Babady NE. Performance of the sōna Aspergillus Galactomannan Lateral Flow Assay in a Cancer Patient Population. J Clin Microbiol. 2021; JCM0059821. 3. Mercier T, et al. Lateral flow assays for diagnosing invasive pulmonary aspergillosis in adult hematology patients: A comparative multicenter study. Med Mycol. 2019. 4. Serin I, Dogu MH. Serum Aspergillus galactomannan lateral flow assay for the diagnosis of invasive aspergillosis: A single-centre study. Mycoses. 2021;64(6):678-683. 5. Mercier T, et al. Point of care aspergillus testing in intensive care patients. Crit Care. 2020. 6. White PL, Price JS, Posso R, Cutlan-Vaughan M, Vale L, Backx M. Evaluation of the Performance of the IMMY sona Aspergillus Galactomannan Lateral Flow Assay When Testing Serum to Aid in Diagnosis of Invasive Aspergillosis. J Clin Microbiol. 2020;58(6):e00053-20. www.alphalabs.co.uk © 2024 Copyright Alpha Laboratories Ltd. 11
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