Establishment of the 1st WHO International Standard for anti-EV71 serum (Human)

Cooper, Gillian; Mao, Qunying; Crawt, Laura; Wang, Yiping; Dougall, Thomas; Rigsby, Peter; Liang, Zhenglun; Xu, Miao; Minor, Philip D.; Wang, Junzhi; Martı́n, Javier

doi:10.1016/j.biologicals.2018.03.001

Cited by 8 publications

(12 citation statements)

References 13 publications

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“…These aforementioned pseudovirus-based NtAbs quantification assays for HFMD associated enteroviruses could be used for evaluation of vaccine induced humoral immune response. Establishment of reference standards like antiserum standards for measuring vaccine-induced NtAb titers is also an important part for bioassay P. Chen et al Journal of Virological Methods 246 (2017) 21-26 development (Cooper et al, 2015;Liang et al, 2011). Furthermore, a new EV-A71 infection mouse model had been successfully established based on EV-A71 pseudovirus, which also showed impressive advantages in efficacy evaluation of EV-A71 vaccine .Thus, introduction of enteroviruse pseudoviruses (e.g.…”

Section: Discussionmentioning

confidence: 99%

Development of a pseudovirus based assay for measuring neutralizing antibodies against coxsackievirus B5

Chen

et al. 2017

Journal of Virological Methods

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Coxsackievirus B5 (CV-B5), an important Coxsackie B virus from genus Enteroviruse within the family Picornaviridae, has also been isolated from Hand, Foot, and Mouth Disease (HFMD) patients, and often associated with neurological manifestations. In this study, we found out that Coxsackievirus B3 (CV-B3) replicon RNA could be encapsidated with CV-B5 capsid to assemble infectious CV-B5 pseudovirus. We then utilized this single round infection system of CV-B5 to develop a neutralizing antibody quantification assay. This pseudovirus neutralization assay showed superiority in biosafety, sensibility, quantitativity, efficiency and high throughput, and would facilitate the epidemiological studies and vaccine development of CV-B5.

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Section: Discussionmentioning

confidence: 99%

Development of a pseudovirus based assay for measuring neutralizing antibodies against coxsackievirus B5

Chen

et al. 2017

Journal of Virological Methods

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“…A number of studies have determined that internal standards provided by the WHO for various pathogens may be useful and should be used to compare results across laboratories and diagnostic methods to help establish correlates of protection for SARS-CoV-2 and other high-threat pathogens (Cooper et al, 2018 ; McDonald et al, 2018 ; Mattiuzzo et al, 2019 , 2020 ; Ciotti et al, 2021 ; Knezevic et al, 2022 ). For example, when assessing candidate reference materials for enterovirus serology, one study evaluating the interassay variability for both the raw neutralization titer and the calculated relative potencies found a marked decrease in interassay variability.…”

Section: Discussionmentioning

confidence: 99%

“…Conversion of results from different laboratory methods to a harmonized international unit reduces the interlaboratory/method variability (Cooper et al, 2018 ; McDonald et al, 2018 ; Mattiuzzo et al, 2019 , 2020 ; Ciotti et al, 2021 ; Knezevic et al, 2022 ). The WHO International Standards (ISs) are considered the highest quality materials to use for comparison between diagnostic methods using international units (Mattiuzzo et al, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Harmonization of Multiple SARS-CoV-2 Reference Materials Using the WHO IS (NIBSC 20/136): Results and Implications

et al. 2022

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BackgroundThere is an urgent need for harmonization between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology platforms and assays prior to defining appropriate correlates of protection and as well inform the development of new rapid diagnostic tests that can be used for serosurveillance as new variants of concern (VOC) emerge. We compared multiple SARS-CoV-2 serology reference materials to the WHO International Standard (WHO IS) to determine their utility as secondary standards, using an international network of laboratories with high-throughput quantitative serology assays. This enabled the comparison of quantitative results between multiple serology platforms.MethodsBetween April and December 2020, 13 well-characterized and validated SARS-CoV-2 serology reference materials were recruited from six different providers to qualify as secondary standards to the WHO IS. All the samples were tested in parallel with the National Institute for Biological Standards and Control (NIBSC) 20/136 and parallel-line assays were used to calculate the relevant potency and binding antibody units.ResultsAll the samples saw varying levels of concordance between diagnostic methods at specific antigen–antibody combinations. Seven of the 12 candidate materials had high concordance for the spike-immunoglobulin G (IgG) analyte [percent coefficient of variation (%CV) between 5 and 44%].ConclusionDespite some concordance between laboratories, qualification of secondary materials to the WHO IS using arbitrary international units or binding antibody units per milliliter (BAU/ml) does not provide any benefit to the reference materials overall, due to the lack of consistent agreeable international unit (IU) or BAU/ml conversions between laboratories. Secondary standards should be qualified to well-characterized reference materials, such as the WHO IS, using serology assays that are similar to the ones used for the original characterization of the WHO IS.

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“…It is hard to compare different serological studies using different serological assays and sampling methods. The first international standard sera for measuring EV-A71 neutralizing antibody titers has been established [29]. It would be desirable to collect sera from different countries using similar sampling methods to measure cross-reactive neutralizing antibody titers using similar neutralization assays incorporating the international standard serum and recent circulating EV-A71 viruses.…”

Section: Discussionmentioning

confidence: 99%

Seroprevalence of EV-A71 neutralizing antibodies following the 2011 epidemic in HCMC, Vietnam

et al. 2020

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Enterovirus-A71 (EV-A71) cyclically causes hand-foot-mouth disease (HFMD) epidemics in Asian children. An EV-A71 epidemic occurred in Southern Vietnam in 2011, but its scale is not clear. We collected residual sera from non-HFMD Vietnamese inpatients in 2012-2013 to determine seroprevalence of EV-A71 neutralizing antibodies, and measured cross-reactive neutralizing antibody titers against three EV-A71 genogroups. About 23.5% of 1-yearold children in Southern Vietnam has been infected by EV-A71, and the median age of infection was estimated to be 3 years. No significant antigenic variation could be detected among the three EV-A71 genogroups. The high seroprevalence of EV-A71 neutralizing antibody in children living in southern Vietnam indicates the necessity of introducing EV-A71 vaccines in southern Vietnam, particularly for children under 6 months of age. Moreover, it is critical to understand EV-A71 disease burden for formulating national vaccination policy. Author summaryEnterovirus-A71 (EV-A71), a member of the enterovirus genus, is a virulent pathogen causing neurological complications. EV-A71 mainly spreads through oral-fecal or oraloral transmission, as well as respiratory droplets. EV-A71 outbreaks have cyclically occurred throughout some Asian countries since 1997, with millions of people affected. The presence of serum neutralizing antibodies to EV-A71 can represent the prevalence of previous EV-A71 infections and seroprevalence studies are widely used to understand prevalence of infectious diseases. The results of our study demonstrate that about 50% of young children under 3 years of age were infected during the 2011 epidemic in southern Vietnam. The high seroprevalence of EV-A71 neutralizing antibody in children living in southern Vietnam indicates the necessity of introducing EV-A71 vaccines, particularly for children under 6 months of age. Moreover, it is critical to understand EV-A71 disease burden for formulating national vaccination policy in the future. PLOS NEGLECTED TROPICAL DISEASESPLOS Neglected Tropical Diseases | https://doi.

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Establishment of the 1st WHO International Standard for anti-EV71 serum (Human)

Cited by 8 publications

References 13 publications

Development of a pseudovirus based assay for measuring neutralizing antibodies against coxsackievirus B5

Development of a pseudovirus based assay for measuring neutralizing antibodies against coxsackievirus B5

Harmonization of Multiple SARS-CoV-2 Reference Materials Using the WHO IS (NIBSC 20/136): Results and Implications

Seroprevalence of EV-A71 neutralizing antibodies following the 2011 epidemic in HCMC, Vietnam

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