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An analytical and clinical evaluation of the PathoNostics AsperGenius Assay for detection of Invasive Aspergillosis and resistance to azole antifungal drugs when testing serum samples.

White, P. Lewis, Posso, Raquel and Barnes, Rosemary Ann 2015. An analytical and clinical evaluation of the PathoNostics AsperGenius Assay for detection of Invasive Aspergillosis and resistance to azole antifungal drugs when testing serum samples. Journal of Clinical Microbiology 53 (7) , pp. 2115-2121. 10.1128/JCM.00667-15

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Abstract

The commercially developed PathoNostics AsperGenius® species assay is a multiplex real-time PCR capable of detecting aspergillosis and genetic markers associated with azole-resistance. The assay is validated for testing broncho-alveolar lavage fluids replacing the requirement for culture and benefiting patient management. Application of this assay to less invasive, easily obtainable samples (e.g. serum) would be advantageous. The aim of this study was to determine the analytical and clinical performance of the AsperGenius® species and resistance assays when testing serum. For the analytical evaluations serum was spiked with various concentrations of Aspergillus genomic DNA for extraction following international recommendations. For the clinical study 124 DNA extracts from 14 proven/probable IA, 2 possible IA cases and 33 controls were tested. The resistance assay was performed on A. fumigatus PCR positive results when sufficient fungal burden was evident. The limits of detection of the species and resistance assays when detecting A. fumigatus DNA were 10 and ≥75 genomes/sample, respectively. Non-reproducible detection at lower burdens was achievable for all markers. Using a positivity threshold of 39 cycles the sensitivity and specificity of the species assay were 78.6% and 100%, respectively. For seven cases of IA at least one genetic region potentially associated with azole-resistance was successfully amplified, although no resistance markers were detected in this small cohort. Summary: The AsperGenius® assay provides good clinical performance with the added ability to detect azole-resistance direct from non-invasive samples. While available burden will limit application it remains a significant advancement in diagnosis and management of aspergillosis.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > R Medicine (General)
R Medicine > RM Therapeutics. Pharmacology
Publisher: American Society for Microbiology
ISSN: 0095-1137
Date of Acceptance: 22 April 2015
Last Modified: 12 Jun 2019 02:56
URI: http://orca.cf.ac.uk/id/eprint/84236

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