Development of Highly Sensitive Analytical Methods for Biologically Relevant Materials and Their Pharmaceutical Applications

Arakawa, Hidetoshi

doi:10.1248/cpb.c17-00787

Cited by 3 publications

(3 citation statements)

References 41 publications

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“…The newly developed SARS-CoV-2 quantitative antigen test (QAT), Lumipulse® SARS-CoV-2 Ag (Fujirebio, Tokyo, Japan), is an assay based on the chemiluminescence enzyme immunoassay (CLEIA) method [3], and it was approved by the Pharmaceutical Affairs Law as a new COVID-19-antigen test kit on June 19, 2020, in Japan [4].…”

mentioning

confidence: 99%

Time-course evaluation of the quantitative antigen test for severe acute respiratory syndrome coronavirus 2: The potential contribution to alleviating isolation of COVID-19 patients

Nomoto¹,

Yamamoto²,

Yamada³

et al. 2021

Journal of Infection and Chemotherapy

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Introduction The automated quantitative antigen test (QAT), which detects severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is suitable for mass screening. However, its diagnostic capability differentiated by time from onset and potential contribution to infectivity assessment have not been fully investigated. Methods A retrospective, observational study using nasopharyngeal swab specimens from coronavirus disease (COVID-19) inpatients was conducted using Lumipulse Ⓡ SARS-CoV-2 antigen test. Diagnostic accuracy was examined for the early (up to 10 days after onset) and late (over 10 days after onset) stages. Time-course QAT changes and reverse‐transcription quantitative polymerase chain reaction tests results were displayed as locally estimated scatterplot smoothing curve, and receiver operating characteristic curve (ROC) analysis was used to determine the appropriate cutoff value for differentiating the early and late stages. Results We obtained 100 specimens from 68 COVID-19 patients, including 51 early-stage and 49 late-stage specimens. QAT sensitivity and specificity were 0.82 (0.72–0.90) and 0.95 (0.75–0.99) for all periods, 0.93 (0.82–0.98) and 1.00 (0.39–1.00) for the early stage, and 0.66 (0.48–0.82) and 0.93 (0.69–0.99) for the late stage, respectively. The ROC analysis indicated an ideal cutoff value of 6.93 pg/mL for distinguishing early-from late-stage specimens. The sensitivity, specificity, positive predictive value, and negative predictive value for predicting the late stage were 0.76 (0.61–0.87), 0.76 (0.63–0.87), 0.76 (0.61–0.87), and 0.76 (0.63–0.87). Conclusions QAT has favorable diagnostic accuracy in the early COVID-19 stages. An appropriate cutoff point can potentially facilitate rapid identification of noncontagious patients.

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confidence: 99%

Time-course evaluation of the quantitative antigen test for severe acute respiratory syndrome coronavirus 2: The potential contribution to alleviating isolation of COVID-19 patients

Nomoto¹,

Yamamoto²,

Yamada³

et al. 2021

Journal of Infection and Chemotherapy

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“…The qualitative rapid antigen test kit was Espline® SARS-CoV-2 (Fujirebio Inc, Japan) (ESP), which uses immunochromatography for detecting SARS-CoV-2 nucleoprotein. Lumipulse® SARS-CoV-2 Ag (LUMI) and Lumipulse® Presto® SARS-CoV-2 Ag (LUMI-P) (Fujirebio, Tokyo, Japan) were quantitative antigen tests based on the chemiluminescence enzyme immunoassay [ 9 ]. Symptomatic patients aged 20 years or older who were considered eligible for NP SARS-CoV-2 RT-qPCR testing within 9 days of onset were recruited in the study.…”

Section: Methodsmentioning

confidence: 99%

Potential usage of anterior nasal sampling in clinical practice with three rapid antigen tests for SARS-CoV-2

Nomoto¹,

Yamamoto²,

Isaka³

et al. 2023

Journal of Infection and Chemotherapy

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“…Embora a qualidade dos métodos analíticos para caracterização de proteínas tenha aumentado drasticamente ao longo das últimas décadas, ainda existem obstáculos à completa caracterização de produtos bioterápicos complexos. Esses dados mostram a importância de testes de qualidade biológica mais detalhados e aprofundados, que podem estabelecer padrões de homogeneidade referente à ação biológica desses produtos frente às suas etapas de produção [19] . Diante disso, através de aplicações biotecnológicas podem ser elaboradas, metodologias que possam ampliar os conhecimentos científicos em controle de qualidade biológico no Brasil, pois a capacitação da mão de obra constitui outro desafio na indústria brasileira.…”

Section: Brazilian Journal Of Natural Sciences | Versão On-line Issn unclassified

Revisão de métodos convencionais de controle de qualidade biológico de biofármacos de origem recombinante e biossimilares e perspectivas de métodos alternativos: https://doi.org/10.31415/bjns.v1i3.36

Blanco¹

2018

Braz. J. Nat. Sci

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A produção de biossimilares ou biofármacos com patentes expiradas pode ser uma oportunidade de crescimento para a indústria biofarmacêutica no Brasil. Entende-se por atividade biológica a habilidade ou capacidade específica do produto em obter um efeito biológico definido. Ela serve a múltiplos propósitos, na avaliação da qualidade do produto, sendo necessária para a caracterização e análise de medicamentos biossimilares, quando de sua comparação com um produto referência. Nessa breve revisão, o principal objetivo é explorar de forma mais critica o desenvolvimento e padronização de novas metodologias, que possam avaliar a atividade biológica de biofármacos e biossimilares, sob a luz de rever os principais modelos celulares utilizados, para desafiar a potencialidade dessas moléculas de atividade biológica, comparado com os modelos clássicos de células da linhagem murinas ou leveduras. A evolução de estudos bioanalíticos em torno desse assunto poderá contribuir para a disponibilização de testes de atividade biológica de maior precisão, gerando resultados mais conclusivos e seguros para os testes clínicos de fase I, II e III, no processo de regulamentação dos biossimilares. Além disso, futuramente a aplicação de testes de avaliação biológica com mais recursos analíticos, poderão ser indicados também como referência metodológica para classes diversas medicamentosas de biofármacos.

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Development of Highly Sensitive Analytical Methods for Biologically Relevant Materials and Their Pharmaceutical Applications

Cited by 3 publications

References 41 publications

Time-course evaluation of the quantitative antigen test for severe acute respiratory syndrome coronavirus 2: The potential contribution to alleviating isolation of COVID-19 patients

Time-course evaluation of the quantitative antigen test for severe acute respiratory syndrome coronavirus 2: The potential contribution to alleviating isolation of COVID-19 patients

Potential usage of anterior nasal sampling in clinical practice with three rapid antigen tests for SARS-CoV-2

Revisão de métodos convencionais de controle de qualidade biológico de biofármacos de origem recombinante e biossimilares e perspectivas de métodos alternativos: https://doi.org/10.31415/bjns.v1i3.36

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