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- W2092861683 abstract "Background and objectives The aim of the study was to replace the 1st World Health Organization International Standard for parvovirus B19 DNA for nucleic acid amplification technique (NAT)-based assays (code 99/800). Two lyophilized preparations (coded 99/800 and 99/802) had been evaluated in the original collaborative study. The present study re-evaluates these two preparations in terms of potency, stability and encapsidation of virus DNA. Materials and methods The 1st International Standard (99/800) and 99/802 were re-coded as Samples 1 and 2, respectively. The samples were distributed to six laboratories and assayed on four separate occasions. Accelerated thermal degradation samples of the two preparations were examined after storage at 20°C for 7 years. Nuclease treatment was used to investigate the encapsidation of virus DNA. Results Data were returned from a total of six different quantitative NAT-based assays. The results of the present study confirm those of the original, with no significant differences found in estimated international units (IU)/ml for the 1st International Standard (Sample 1 in this study) and the proposed replacement preparation, Sample 2 (99/802). Accelerated thermal degradation studies demonstrate that both samples are very stable, with no loss of potency after storage at 20°C for 7 years. Both lyophilized preparations contained the majority of B19V DNA encapsidated in virions. Conclusions On the basis of the data presented in this collaborative study, Sample 2 (code number 99/802) was established as the 2nd International Standard for parvovirus B19 DNA for NAT-based assays with a potency of 106 IU/ml (500 000 IU/vial)." @default.
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- W2092861683 date "2010-04-01" @default.
- W2092861683 modified "2023-09-27" @default.
- W2092861683 title "Collaborative study to establish a replacement World Health Organization International Standard for parvovirus B19 DNA nucleic acid amplification technology (NAT)-based assays" @default.
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- W2092861683 doi "https://doi.org/10.1111/j.1423-0410.2009.01288.x" @default.
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