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Collaborative study to establish a replacement World Health Organization International Standard for parvovirus B19 DNA nucleic acid amplification technology (NAT)‐based assays
Author(s) -
Baylis S. A.,
Chudy M.,
Blümel J.,
Pisani G.,
Candotti D.,
José M.,
Heath A. B.
Publication year - 2010
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/j.1423-0410.2009.01288.x
Subject(s) - nat , parvovirus , nucleic acid , dna , potency , virology , nuclease , chemistry , microbiology and biotechnology , biology , virus , biochemistry , mathematics , in vitro , statistics
Background and objectives The aim of the study was to replace the 1 st 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 1 st 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 1 st 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 2 nd International Standard for parvovirus B19 DNA for NAT‐based assays with a potency of 10 6 IU/ml (500 000 IU/vial).