Mee Edward T, Preston Mark D, Minor Philip D, Schepelmann Silke
Division of Virology, National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, South Mimms, Hertfordshire EN6 3QG, United Kingdom.
Division of Technology, Development and Infrastructure, National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, South Mimms, Hertfordshire EN6 3QG, United Kingdom.
Vaccine. 2016 Apr 12;34(17):2035-43. doi: 10.1016/j.vaccine.2015.12.020. Epub 2015 Dec 19.
Unbiased deep sequencing offers the potential for improved adventitious virus screening in vaccines and biotherapeutics. Successful implementation of such assays will require appropriate control materials to confirm assay performance and sensitivity.
A common reference material containing 25 target viruses was produced and 16 laboratories were invited to process it using their preferred adventitious virus detection assay.
Fifteen laboratories returned results, obtained using a wide range of wet-lab and informatics methods. Six of 25 target viruses were detected by all laboratories, with the remaining viruses detected by 4-14 laboratories. Six non-target viruses were detected by three or more laboratories.
The study demonstrated that a wide range of methods are currently used for adventitious virus detection screening in biological products by deep sequencing and that they can yield significantly different results. This underscores the need for common reference materials to ensure satisfactory assay performance and enable comparisons between laboratories.
无偏深度测序为改进疫苗和生物治疗药物中的外源病毒筛查提供了可能。成功实施此类检测需要合适的对照材料来确认检测性能和灵敏度。
制备了一种含有25种目标病毒的通用参考材料，并邀请16个实验室使用他们首选的外源病毒检测方法对其进行处理。
15个实验室返回了结果，这些结果是使用多种湿实验室和信息学方法获得的。25种目标病毒中有6种被所有实验室检测到，其余病毒被4至14个实验室检测到。6种非目标病毒被3个或更多实验室检测到。
该研究表明，目前深度测序在生物制品外源病毒检测筛查中使用了多种方法，且这些方法可能产生显著不同的结果。这凸显了需要通用参考材料以确保检测性能令人满意并实现实验室间的比较。
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