Analytical and Clinical Evaluation of the PathoNostics AsperGenius Assay for Detection of Invasive Aspergillosis and Resistance to Azole Antifungal Drugs Directly from Plasma Samples

Journal of Clinical Microbiology
P Lewis WhiteRosemary A Barnes

Abstract

With the proposal to include Aspergillus PCR in the revised European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) definitions for fungal disease, commercially manufactured assays may be required to provide standardization and accessibility. The PathoNostics AsperGenius assay represents one such test that has the ability to detect a range of Aspergillus species as well as azole resistance in Aspergillus fumigatus Its performance has been validated on bronchoalveolar lavage (BAL) fluid and serum specimens, but recent evidence suggests that testing of plasma may have enhanced sensitivity over that with serum. We decided to evaluate the analytical and clinical performances of the PathoNostics AsperGenius assay for testing of plasma. For the analytical evaluations, plasma was spiked with various concentrations of Aspergillus genomic DNA before extraction following international recommendations, using two automated platforms. For the clinical study, 211 samples from 10 proven/probable invasive aspergillosis (IA) and 2 possible IA cases and 27 controls were tested. The limits of detection for test...Continue Reading

References

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Citations

Feb 15, 2019·Journal of Chemotherapy·Peral JoséRafael Zaragoza
Mar 1, 2019·Medical Mycology·François DanionOlivier Lortholary
Jan 5, 2020·Proceedings of the National Academy of Sciences of the United States of America·Paul BowyerDavid W Denning
Jan 16, 2020·Journal of Fungi·Mireille H van der TorreRiina Rautemaa-Richardson
Feb 8, 2020·Expert Review of Molecular Diagnostics·Peter J DaileyMark Holodniy
Feb 6, 2020·Journal of Fungi·Matthias EggerJuergen Prattes
Aug 29, 2020·Current Protocols in Microbiology·Amelie P BrackinThomas R Sewell
Aug 31, 2020·The Journal of Antimicrobial Chemotherapy·Lilyann Novak-FrazerRiina Rautemaa-Richardson
Sep 26, 2019·Current Fungal Infection Reports·Jeffrey D JenksMartin Hoenigl
Jan 30, 2020·Frontiers in Microbiology·Sarah E KiddCatriona L Halliday
Apr 6, 2018·Frontiers in Microbiology·Jochem B BuilWillem J G Melchers
Dec 19, 2018·Journal of Fungi·Chris D LauruschkatJuergen Loeffler
May 10, 2018·Frontiers in Microbiology·Peter-Michael Rath, Joerg Steinmann
Dec 6, 2019·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·J Peter DonnellyPeter G Pappas
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Sep 8, 2021·Mycopathologia·Amelie P BrackinJohanna Rhodes
Sep 12, 2021·The Journal of Antimicrobial Chemotherapy·Monica A SlavinJohan A Maertens

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