Collaborative study to establish a World Health Organization International genotype panel for parvovirus B19 DNA nucleic acid amplification technology (NAT)-based assays.
Vox Sang
; 102(3): 204-11, 2012 Apr.
Article
em En
| MEDLINE
| ID: mdl-21988191
ABSTRACT
BACKGROUND AND OBJECTIVES:
The aim of the collaborative study was to evaluate a panel of plasma samples containing different genotypes of parvovirus B19 (B19V) for use in nucleic acid amplification technology (NAT)-based assays. MATERIALS ANDMETHODS:
The panel of samples [Center for Biologics Evaluation and Research Parvovirus B19 Genotype Panel 1; National Institute for Biological Standards and Control (NIBSC) code number 09/110] comprises four different members, i.e. Member 1, Member 2, Member 3, and Member 4 (M1-M4); these represent genotypes 1, 2, 3a B19V, and a negative plasma control, respectively. Thirty-five laboratories from 13 different countries participated in the study. Participants assayed the panel members concurrently with the 2nd World Health Organization (WHO) International Standard for B19V DNA (NIBSC code 99/802) on four separate occasions.RESULTS:
A total of 44 sets of data were returned, 34 from quantitative assays and 10 from qualitative assays. The majority of assays used were in-house and based on real-time PCR. The results showed that all three genotypes were detected consistently by the majority of participants, although a small number of assays detected genotypes 2 and 3 less efficiently, or not at all. Real-time stability studies have indicated that the panel of B19V samples is stable under normal conditions of storage, i.e. ≤-70°C.CONCLUSIONS:
The four-member panel is intended for use in evaluating the ability of NAT assays to detect different B19V genotypes (M1-M3). Based on the results of the collaborative study, the panel was established as the 1st WHO International Reference Panel for parvovirus B19 genotypes.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Organização Mundial da Saúde
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DNA Viral
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Parvovirus B19 Humano
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Infecções por Parvoviridae
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Técnicas de Amplificação de Ácido Nucleico
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Genótipo
Tipo de estudo:
Clinical_trials
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Qualitative_research
Limite:
Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2012
Tipo de documento:
Article