Update on Zika Diagnostic Tests and WHO’s Related Activities

Chua, Arlene; Prat, Irena; Nuebling, Claudius Micha; Wood, David; Moussy, Francis

doi:10.1371/journal.pntd.0005269

Cited by 35 publications

(32 citation statements)

References 27 publications

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“…While it is relatively straightforward to detect ZIKV nucleic acids during the acute phase in blood, urine, saliva, and semen, it has proven more difficult to design rapid and effective diagnostics for prior ZIKV exposure (Chua et al, 2017). This is reflected by the U.S. Food and Drug Administration (FDA) website where Emergency Use Authorization (EUA) has been obtained for 11 RNA-based assays and only two tests for IgM (FDA, 2017).…”

Section: Current Status Of Diagnostic Testing (Diogo M Magnani Mmentioning

confidence: 99%

Zika in the Americas, year 2: What have we learned? What gaps remain? A report from the Global Virus Network

et al. 2017

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In response to the outbreak of Zika virus (ZIKV) infection in the Western Hemisphere and the recognition of a causal association with fetal malformations, the Global Virus Network (GVN) assembled an international taskforce of virologists to promote basic research, recommend public health measures and encourage the rapid development of vaccines, antiviral therapies and new diagnostic tests. In this article, taskforce members and other experts review what has been learned about ZIKV-induced disease in humans, its modes of transmission and the cause and nature of associated congenital manifestations. After describing the make-up of the taskforce, we summarize the emergence of ZIKV in the Americas, Africa and Asia, its spread by mosquitoes, and current control measures. We then review the spectrum of primary ZIKV-induced disease in adults and children, sites of persistent infection and sexual transmission, then examine what has been learned about maternal-fetal transmission and the congenital Zika syndrome, including knowledge obtained from studies in laboratory animals. Subsequent sections focus on vaccine development, antiviral therapeutics and new diagnostic tests. After reviewing current understanding of the mechanisms of emergence of Zika virus, we consider the likely future of the pandemic.

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Section: Current Status Of Diagnostic Testing (Diogo M Magnani Mmentioning

confidence: 99%

Zika in the Americas, year 2: What have we learned? What gaps remain? A report from the Global Virus Network

et al. 2017

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“…Therefore, care must be taken when interpreting the results of serosurveys in areas with cocirculation of other flaviviruses, or routine JE or YF vaccination. With the emergence of Zika in South America and the large epidemic observed in 2015-2016, cross-reactivity may be of particular concern since there are currently no commercially available diagnostics or internationally recognised standards for Zika diagnosis [29]. In the context of conducting serosurveys to inform dengue vaccination, WHO recommend that a subset of samples is retested using neutralisation tests such as plaque-reduction neutralisation tests (PRNTs) as they do not detect the same cross-reactivity.…”

Section: Discussionmentioning

confidence: 99%

Targeting Vaccinations for the Licensed Dengue Vaccine: Considerations for Serosurvey Design

Imai

Ferguson

2017

Preprint

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Objective: WHO recommends countries consider dengue vaccination in geographic settings only where epidemiological data indicate a high burden of disease. In defining target populations, WHO recommend that prior infection with any dengue serotype should be >70% seroprevalence. Here we address considerations for serosurvey design in the context of the newly licensed CYD-TDV vaccine.Methods: To explore how the design of seroprevalence surveys (age range, survey size) would affect estimates of the force of infection, for every combination of age range, total survey size, transmission setting, and test sensitivity/specificity, 100 age-specific seroprevalence surveys were simulated using a beta-binomial distribution and a simple catalytic model. The transmission intensity was then re-estimated using a MetropolisHastings Markov Chain Monte-Carlo algorithm.Findings: Sampling from a wide age range led to more accurate estimates than having a larger sample size. This finding was consistent across all transmission settings. The optimal age range to sample from differed by transmission intensity, with younger and older ages being important in high and low transmission settings respectively. The optimum test sensitivity and specificity given an imperfect test also differed by transmission setting with high sensitivity being important in high transmission settings and high specificity important in low transmission settings.Conclusions: When assessing the suitability for vaccination by seroprevalence surveys, countries should ensure that an appropriate age range is sampled, taking into account epidemiological evidence about the local burden of dengue.

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“…Laboratory confirmation of a diagnosis for patient treatment must have sufficient clinical sensitivity and specificity to be useful, the criteria for which may be different than analytical sensitivity and specificity criteria specified by assays for use in vaccine trials. [38][39][40][41][42][43][44][45] Very few tests have gained Emergency Use Authorization (EUA) from the FDA. There are 2 MERS-CoV diagnostic tests, both molecular-based viral RNA detection, which received EUA in 2013 in response to the recognition of the significant potential for a future public health emergency.…”

Section: Diagnostics For Emerging Infectious Diseasesmentioning

confidence: 99%

“…62 EID public health and countermeasure programs have unique challenges for diagnostic and vaccine clinical assay development purposes. 2,39,41,[63][64][65][66][67][68][69][70][71] There may be an incomplete understanding of the biology or epidemiology of a new pathogen, which can delay or confound the selection of a relevant vaccine target and the subsequent assay development to be used to evaluate the candidates. The field may suffer from a lack of available reagent sources or with inconsistency in quantity and quality of those available, especially early in the discovery and development process.…”

Section: Future Preparedness For Eidsmentioning

confidence: 99%

Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development

Roberts¹

2019

Human Vaccines & Immunotherapeutics

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Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.

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Update on Zika Diagnostic Tests and WHO’s Related Activities

Cited by 35 publications

References 27 publications

Zika in the Americas, year 2: What have we learned? What gaps remain? A report from the Global Virus Network

Zika in the Americas, year 2: What have we learned? What gaps remain? A report from the Global Virus Network

Targeting Vaccinations for the Licensed Dengue Vaccine: Considerations for Serosurvey Design

Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development

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