摘 要 目的：为解决目前支原体检测方法操作复杂、耗时长、灵敏度低等问题，按照《中华人民共和国药典》(ChP)、美国药典(USP)、欧洲药典(EP)生物制品支原体检测方法及验证指导原则，构建一种快速芯片式的支原体检测方法，并对该方法检测能力进行验证。方法：采用Taqman探针法，并利用快速qPCR仪结合芯片检测支原体，快速高效，可极大降低检测成本。结果与结论：本研究建立的基于qPCR的支原体检测方法特异性强、稳定性佳、可重复性好，可为支原体感染的诊断检测和流行病学调查提供方法学支持。

    关键词 支原体残留 探针法 qPCR

    中图分类号：Q93-332 文献标志码：A 文章编号：1006-1533(2024)19-0085-05

    引用本文 姚杰， 黄懿. 芯片式支原体qPCR检测技术的开发与应用研究[J]. 上海医药， 2024， 45(19)： 85-89.

    Development and application of chip qPCR technology for mycoplasma detection

    YAO Jie， HUANG Yi

    (Shanghai Tanshi Biotechnology Co.， Ltd.， Shanghai 201206， China)

    ABSTRACT Objective： In order to solve the problems of complex operation， long time and low sensitivity of the current detection methods for mycoplasma， a rapid chip-based mycoplasma detection method was established and a simple methodological validation was performed according to the principles of biological product mycoplasma inspection and method validation guidance in the Chinese Pharmacopoeia (ChP)， United States Pharmacopeia (USP)， and European Pharmacopoeia (EP). Methods： The mycoplasma residue in cells or biological products was accurately and stably detected by Taqman probe method based on the rapid qPCR instrument combined with the chip ......