传染病体外诊断试剂标准物质研制技术要求的介绍

传染病体外诊断试剂标准物质是指用于与致病性病原体抗原、抗体以及核酸等检测相关的试剂质量评价的标准物质。为进一步规范该类标准物质的研制工作,中检院制定了相关的研制技术规范。本文详细介绍该规范中对传染病体外诊断试剂标准物质的原材料、制备、标定、稳定性研究、包装、储存及供应方面的要求。

Introduction of general technical guidance of the diagnostic reagents reference standards for infectious disease in vitro

The meaning of reference standards for infectious disease diagnostic reagents in vitro is to evaluate the quality of detection reagent on pathogenic pathogen antigens,antibodies,nucleic acid,etc.To further standardize the work,particular technical specifications have been established in NIFDC.This article introduced the general technical guidance on the source of candidate,evaluation,assignment of content,maintenance and distribution of reference standards for infectious disease diagnostic reagents in vitro...