Utilize este identificador para referenciar este registo: http://hdl.handle.net/10400.18/5348
Título: Collaborative study to evaluate a candidate World Health Organization international standard for chikungunya virus for nucleic acid amplification technique (NAT)-based assays
Autor: KreB, J.A.
Hanschmann, K-M.O.
Chudy, M.
Collaborative Study Group
Palavras-chave: Chikungunya Virus
Evaluate Candidate
Standard
Nucleic Acid Amplification Techniques
Biological Assay
Reference Standards
Infecções Sistémicas e Zoonoses
Data: Out-2017
Editora: World Health Organization
Relatório da Série N.º: WHO/BS/2017.2330
Resumo: This report describes the World Health Organization (WHO) project to develop an international standard (IS) for Chikungunya virus (CHIKV) RNA for use with nucleic acid amplification technique (NAT)-based assays. An international collaborative study was conducted to determine the potency of the candidate standard using a range of NAT-based assays for CHIKV, and to evaluate the suitability of the candidate for the calibration of secondary reference materials and the standardization of CHIKV viral load measurements. The candidate standard consisted of a heat inactivated CHIKV strain of the East/South/Central African genotype (ESCA), also known as the Indian Ocean Lineage, isolated from a patient returning from India to the United States in 20061 , diluted in human negative plasma. The lyophilized candidate preparation (Sample 1), the corresponding liquid-frozen bulk material (Sample 2) and three different clinical samples (Sample 3, Sample 4 and Sample 5) were included in the collaborative study. Twenty-five laboratories representing 14 countries participated in the study to evaluate the material using their routine CHIKV NAT assays. Twenty-four laboratories returned 31 data sets from 17 commercial assays and 14 in-house methods. Of these 31 methods, 11 were quantitative and 20 were qualitative. The results of the study indicate the suitability of the candidate material of the CHIKV strain of ESCA genotype (Sample 1) as the proposed 1st WHO IS for CHIKV. It is therefore proposed that the candidate material (PEI code 11785/16) is established as the 1st WHO IS for CHIKV RNA for NAT-based assays with an assigned potency of 2,500,000 International Units (IU)/mL when reconstituted in 0.5 mL of nuclease-free water. On-going studies for real-time and accelerated stability of the proposed IS indicate that the preparation is stable and suitable for long-term use under the proposed storage conditions.
Descrição: Collaborative Study Group - Portugal:Maria João Alves, Líbia Zé-Zé (National Institute of Health Dr. Ricardo Jorge, Center for Vectors and Infectious Diseases Research)
Peer review: yes
URI: http://hdl.handle.net/10400.18/5348
Versão do Editor: http://www.who.int/iris/handle/10665/260265
Aparece nas colecções:DDI - Relatórios científicos e técnicos

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218 WHO_BS_2017_2330_1st IS CHIKV RNA_final_Nov2017.pdf5,48 MBAdobe PDFVer/Abrir


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