体外诊断试剂样本稳定性评价要求及关注要点

Requirements and key points for stability evaluation of in vitro diagnostic reagent samples

如何评价体外诊断试剂样本稳定性是制造商应当关注的问题。本文根据《体外诊断试剂注册申报资料要求及说明》,结合已发布的各项注册申报审查指导原则及共性问题,阐述样本稳定性研究的要求,以及评价方案应当考虑在“最差条件下”选取不同时间点进行正确度结果比对,同时尽量使用同批次、效期内试剂及避免其他因素导致的随机误差,并在不同的样本类型、样本浓度及数量上选择的科学、合理。

The focus of manufacturers is how to evaluate the stability of in vitro diagnostic reagent samples.This paper aims to expound on the requirements for sample stability research,according to the requirements and instructions for registration and application materials of in vitro diagnostic reagents.The evalua⁃tion scheme should consider selecting different time points under the“worst conditions”for correct result comparison.Additionally,it is important to use the same batch of reagents within their validity period to avoid random errors caused by other factors.Scientific and reasonable selection should be made in different sample types,concentrations,and quantities.