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2042. Clinical Application of AspID PCR Alone and in Combination with Aspergillus Lateral Flow Device (AspLFD) in Bronchoalveolar Lavage (BAL) Fluid of Patients with Classic Risk Factors for Invasive Pulmonary Aspergillosis (IPA)

BACKGROUND: Early diagnosis of IPA is challenging and has a direct impact on mortality. Several diagnostic modalities have been developed with variable performance. AspID is a new multiplex Aspergillus qRT-PCR assay and AspLFD is a rapid test that targets the Aspergillus specific antigen JF5; both t...

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Autores principales: Linder, Kathleen A, Flaherty, Melanie, Zhou, Shiwei, Diaz, Jose A, Kauffman, Carol A, Miceli, Marisa H
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6252613/
http://dx.doi.org/10.1093/ofid/ofy210.1698
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author Linder, Kathleen A
Flaherty, Melanie
Zhou, Shiwei
Diaz, Jose A
Kauffman, Carol A
Miceli, Marisa H
author_facet Linder, Kathleen A
Flaherty, Melanie
Zhou, Shiwei
Diaz, Jose A
Kauffman, Carol A
Miceli, Marisa H
author_sort Linder, Kathleen A
collection PubMed
description BACKGROUND: Early diagnosis of IPA is challenging and has a direct impact on mortality. Several diagnostic modalities have been developed with variable performance. AspID is a new multiplex Aspergillus qRT-PCR assay and AspLFD is a rapid test that targets the Aspergillus specific antigen JF5; both tests were developed by OLM Diagnostics. We evaluated the performance characteristics of AspID used alone and in combination with AspLFD on BAL fluid of patients at high risk for IPA. METHODS: Samples had been prospectively banked in our BAL repository. Forty-two samples, 14 from patients with proven/probable IPA by EORTC/MSG criteria and 28 from control patients without IPA, were tested with AspID and AspLFD. For AspID, DNA extraction and qRT-PCR were performed per manufacturer instructions. For AspLFD, 100 μL of sample was applied to the device. AspID and AspLFD results were each read by three different blinded observers. Only patient with a valid result for both tests were included in the analysis. Sensitivity, specificity, and accuracy of AspID alone and in combination with AspLFD were calculated. RESULTS: Of the 42 samples, 22 were excluded because the AspID internal extraction control showed the assay to be invalid and one sample was excluded because the AspLFD internal control line was not visible. Thus, 19 patients were analyzed, eight with IPA and 11 without IPA. Among eight IPA cases, seven were positive by AspID and one was negative; two tested positive by AspLFD and six were negative. Of the 11 control patients without IPA, four were positive by AspID and seven were negative; all 11 were negative by AspLFD. AspID sensitivity was significantly higher than that of AspLFD (87.5% vs. 25%, P = .0001), but specificity of AspLFD was superior to that of AspID (100% vs. 64%, P = 0.049). Accuracy was 74% for AspID and 68% for AspLFD. When deciding whether doing both tests was beneficial for diagnosis, union analysis showed the sensitivity to be 87.5% and the specificity to be 64%. Accuracy was not improved and remained at 74%. CONCLUSION: AspID had higher sensitivity than AspLFD and AspLFD had higher specificity than AspID. Using both tests in combination did not improve the ability to diagnose IPA in patients with classic risk factors. DISCLOSURES: All authors: No reported disclosures.
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spelling pubmed-62526132018-11-28 2042. Clinical Application of AspID PCR Alone and in Combination with Aspergillus Lateral Flow Device (AspLFD) in Bronchoalveolar Lavage (BAL) Fluid of Patients with Classic Risk Factors for Invasive Pulmonary Aspergillosis (IPA) Linder, Kathleen A Flaherty, Melanie Zhou, Shiwei Diaz, Jose A Kauffman, Carol A Miceli, Marisa H Open Forum Infect Dis Abstracts BACKGROUND: Early diagnosis of IPA is challenging and has a direct impact on mortality. Several diagnostic modalities have been developed with variable performance. AspID is a new multiplex Aspergillus qRT-PCR assay and AspLFD is a rapid test that targets the Aspergillus specific antigen JF5; both tests were developed by OLM Diagnostics. We evaluated the performance characteristics of AspID used alone and in combination with AspLFD on BAL fluid of patients at high risk for IPA. METHODS: Samples had been prospectively banked in our BAL repository. Forty-two samples, 14 from patients with proven/probable IPA by EORTC/MSG criteria and 28 from control patients without IPA, were tested with AspID and AspLFD. For AspID, DNA extraction and qRT-PCR were performed per manufacturer instructions. For AspLFD, 100 μL of sample was applied to the device. AspID and AspLFD results were each read by three different blinded observers. Only patient with a valid result for both tests were included in the analysis. Sensitivity, specificity, and accuracy of AspID alone and in combination with AspLFD were calculated. RESULTS: Of the 42 samples, 22 were excluded because the AspID internal extraction control showed the assay to be invalid and one sample was excluded because the AspLFD internal control line was not visible. Thus, 19 patients were analyzed, eight with IPA and 11 without IPA. Among eight IPA cases, seven were positive by AspID and one was negative; two tested positive by AspLFD and six were negative. Of the 11 control patients without IPA, four were positive by AspID and seven were negative; all 11 were negative by AspLFD. AspID sensitivity was significantly higher than that of AspLFD (87.5% vs. 25%, P = .0001), but specificity of AspLFD was superior to that of AspID (100% vs. 64%, P = 0.049). Accuracy was 74% for AspID and 68% for AspLFD. When deciding whether doing both tests was beneficial for diagnosis, union analysis showed the sensitivity to be 87.5% and the specificity to be 64%. Accuracy was not improved and remained at 74%. CONCLUSION: AspID had higher sensitivity than AspLFD and AspLFD had higher specificity than AspID. Using both tests in combination did not improve the ability to diagnose IPA in patients with classic risk factors. DISCLOSURES: All authors: No reported disclosures. Oxford University Press 2018-11-26 /pmc/articles/PMC6252613/ http://dx.doi.org/10.1093/ofid/ofy210.1698 Text en © The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Abstracts
Linder, Kathleen A
Flaherty, Melanie
Zhou, Shiwei
Diaz, Jose A
Kauffman, Carol A
Miceli, Marisa H
2042. Clinical Application of AspID PCR Alone and in Combination with Aspergillus Lateral Flow Device (AspLFD) in Bronchoalveolar Lavage (BAL) Fluid of Patients with Classic Risk Factors for Invasive Pulmonary Aspergillosis (IPA)
title 2042. Clinical Application of AspID PCR Alone and in Combination with Aspergillus Lateral Flow Device (AspLFD) in Bronchoalveolar Lavage (BAL) Fluid of Patients with Classic Risk Factors for Invasive Pulmonary Aspergillosis (IPA)
title_full 2042. Clinical Application of AspID PCR Alone and in Combination with Aspergillus Lateral Flow Device (AspLFD) in Bronchoalveolar Lavage (BAL) Fluid of Patients with Classic Risk Factors for Invasive Pulmonary Aspergillosis (IPA)
title_fullStr 2042. Clinical Application of AspID PCR Alone and in Combination with Aspergillus Lateral Flow Device (AspLFD) in Bronchoalveolar Lavage (BAL) Fluid of Patients with Classic Risk Factors for Invasive Pulmonary Aspergillosis (IPA)
title_full_unstemmed 2042. Clinical Application of AspID PCR Alone and in Combination with Aspergillus Lateral Flow Device (AspLFD) in Bronchoalveolar Lavage (BAL) Fluid of Patients with Classic Risk Factors for Invasive Pulmonary Aspergillosis (IPA)
title_short 2042. Clinical Application of AspID PCR Alone and in Combination with Aspergillus Lateral Flow Device (AspLFD) in Bronchoalveolar Lavage (BAL) Fluid of Patients with Classic Risk Factors for Invasive Pulmonary Aspergillosis (IPA)
title_sort 2042. clinical application of aspid pcr alone and in combination with aspergillus lateral flow device (asplfd) in bronchoalveolar lavage (bal) fluid of patients with classic risk factors for invasive pulmonary aspergillosis (ipa)
topic Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6252613/
http://dx.doi.org/10.1093/ofid/ofy210.1698
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