Standardized evaluation of Zika nucleic acid tests used in clinical settings and blood screening.
Early detection of Zika virus (ZIKV) transmission within geographic regions informs implementation of community mitigation measures such as vector reduction strategies, travel advisories, enhanced surveillance among pregnant women, and possible implementation of blood and organ donor screening or de...
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ftdoajarticles:oai:doaj.org/article:4beae65d0388465081cfa7d085a1a662 2023-06-11T04:09:54+02:00 Standardized evaluation of Zika nucleic acid tests used in clinical settings and blood screening. Mars Stone Sonia Bakkour Eduard Grebe Devy M Emperador Camille Escadafal Xutao Deng Honey Dave Cassandra Kelly-Cirino Eve Lackritz Diana P Rojas Graham Simmons Ingrid B Rabe Michael P Busch 2023-03-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0011157 https://doaj.org/article/4beae65d0388465081cfa7d085a1a662 EN eng Public Library of Science (PLoS) https://doi.org/10.1371/journal.pntd.0011157 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0011157 https://doaj.org/article/4beae65d0388465081cfa7d085a1a662 PLoS Neglected Tropical Diseases, Vol 17, Iss 3, p e0011157 (2023) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2023 ftdoajarticles https://doi.org/10.1371/journal.pntd.0011157 2023-05-07T00:31:57Z Early detection of Zika virus (ZIKV) transmission within geographic regions informs implementation of community mitigation measures such as vector reduction strategies, travel advisories, enhanced surveillance among pregnant women, and possible implementation of blood and organ donor screening or deferral. Standardized, comparative assessments of ZIKV assay and testing lab performance are important to develop optimal approaches to ZIKV diagnostic testing and surveillance. We conducted an expanded blinded panel study to characterize and compare the analytical performance of fifteen diagnostic and blood screening ZIKV NAT assays, including detection among single- and multiplex assays detecting ZIKV, dengue virus (DENV) and chikungunya virus (CHIKV). A 300 member blinded panel was constructed, consisting of 11 serial half-log dilutions ranging from ~104 to 10-1 genome equivalents/mL in 25 replicates each of the Tahitian Asian ZIKV isolate in ZIKV-negative human serum. Additionally, clinical samples from individuals with DENV-like syndrome or suspected ZIKV infection in Brazil were evaluated. The majority of assays demonstrated good specificity. Analytical sensitivities varied 1-2 logs, with a substantially higher limit of detection (LOD) in one outlier. Similar analytical sensitivity for ZIKV RNA detection in singleplex and multiplex assays of the Grifols and ThermoFisher tests were observed. Coefficient of Assay Efficiency (CE), calculated to characterize assays' RNA extraction and amplification efficiency, ranged from 0.13 for the Certest VIASURE multiplex and 0.75 for the Grifols multiplex assays. In general, assays using transcription mediated amplification (TMA) technology had greater CE compared to assays using conventional PCR technology. Donor screening NAT assays were significantly more sensitive than diagnostic RT-qPCR assays, primarily attributable to higher sample input volumes. However, ideal assays to maximize sensitivity and throughput may not be a viable option in all contexts, with other factors ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 17 3 e0011157 |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Mars Stone Sonia Bakkour Eduard Grebe Devy M Emperador Camille Escadafal Xutao Deng Honey Dave Cassandra Kelly-Cirino Eve Lackritz Diana P Rojas Graham Simmons Ingrid B Rabe Michael P Busch Standardized evaluation of Zika nucleic acid tests used in clinical settings and blood screening. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Early detection of Zika virus (ZIKV) transmission within geographic regions informs implementation of community mitigation measures such as vector reduction strategies, travel advisories, enhanced surveillance among pregnant women, and possible implementation of blood and organ donor screening or deferral. Standardized, comparative assessments of ZIKV assay and testing lab performance are important to develop optimal approaches to ZIKV diagnostic testing and surveillance. We conducted an expanded blinded panel study to characterize and compare the analytical performance of fifteen diagnostic and blood screening ZIKV NAT assays, including detection among single- and multiplex assays detecting ZIKV, dengue virus (DENV) and chikungunya virus (CHIKV). A 300 member blinded panel was constructed, consisting of 11 serial half-log dilutions ranging from ~104 to 10-1 genome equivalents/mL in 25 replicates each of the Tahitian Asian ZIKV isolate in ZIKV-negative human serum. Additionally, clinical samples from individuals with DENV-like syndrome or suspected ZIKV infection in Brazil were evaluated. The majority of assays demonstrated good specificity. Analytical sensitivities varied 1-2 logs, with a substantially higher limit of detection (LOD) in one outlier. Similar analytical sensitivity for ZIKV RNA detection in singleplex and multiplex assays of the Grifols and ThermoFisher tests were observed. Coefficient of Assay Efficiency (CE), calculated to characterize assays' RNA extraction and amplification efficiency, ranged from 0.13 for the Certest VIASURE multiplex and 0.75 for the Grifols multiplex assays. In general, assays using transcription mediated amplification (TMA) technology had greater CE compared to assays using conventional PCR technology. Donor screening NAT assays were significantly more sensitive than diagnostic RT-qPCR assays, primarily attributable to higher sample input volumes. However, ideal assays to maximize sensitivity and throughput may not be a viable option in all contexts, with other factors ... |
format |
Article in Journal/Newspaper |
author |
Mars Stone Sonia Bakkour Eduard Grebe Devy M Emperador Camille Escadafal Xutao Deng Honey Dave Cassandra Kelly-Cirino Eve Lackritz Diana P Rojas Graham Simmons Ingrid B Rabe Michael P Busch |
author_facet |
Mars Stone Sonia Bakkour Eduard Grebe Devy M Emperador Camille Escadafal Xutao Deng Honey Dave Cassandra Kelly-Cirino Eve Lackritz Diana P Rojas Graham Simmons Ingrid B Rabe Michael P Busch |
author_sort |
Mars Stone |
title |
Standardized evaluation of Zika nucleic acid tests used in clinical settings and blood screening. |
title_short |
Standardized evaluation of Zika nucleic acid tests used in clinical settings and blood screening. |
title_full |
Standardized evaluation of Zika nucleic acid tests used in clinical settings and blood screening. |
title_fullStr |
Standardized evaluation of Zika nucleic acid tests used in clinical settings and blood screening. |
title_full_unstemmed |
Standardized evaluation of Zika nucleic acid tests used in clinical settings and blood screening. |
title_sort |
standardized evaluation of zika nucleic acid tests used in clinical settings and blood screening. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2023 |
url |
https://doi.org/10.1371/journal.pntd.0011157 https://doaj.org/article/4beae65d0388465081cfa7d085a1a662 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 17, Iss 3, p e0011157 (2023) |
op_relation |
https://doi.org/10.1371/journal.pntd.0011157 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0011157 https://doaj.org/article/4beae65d0388465081cfa7d085a1a662 |
op_doi |
https://doi.org/10.1371/journal.pntd.0011157 |
container_title |
PLOS Neglected Tropical Diseases |
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17 |
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3 |
container_start_page |
e0011157 |
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1768383912372862976 |