GLP体系下精子分析仪的3Q验证

3Q Verification of Sperm Analyzer in GLP System

本文以HAMITON TXO IVOS精子分析仪为例,探讨了良好实验室规范(GLP)体系下精子分析仪的3Q验证过程。实验描述了精子分析仪的安装验证(IQ)、操作验证(OQ)和性能验证(PQ)过程,重点对精子分析仪的载物台温控、标尺精度、计数和分辨性能、精子识别、软件计算等性能进行验证,从而证明设备符合GLP要求,保证分析数据的准确可靠性。结果显示,精子分析仪能正确识别精子和非精子,有效追踪精子的运动轨迹,软件计算准确。精子分析仪的3Q验证证明精子分析仪各方面性能优良,可以用于评估精子形态学和动力学指标。

This paper takes HAMITON TXO IVOS sperm analyzer as an example to discuss the validation process of 3Q sperm analyzer under good laboratory specification(GLP)system.This experiment describes the processes of IQ,OQ and PQ of the sperm analyzer,and focuses on the performance verification of the platform temperature control,ruler accuracy,counting and discrimination performance,sperm recognition,and software calculation of the sperm analyzer,so as to prove that the equipment meets the requirements of GLP and ensure the accuracy and reliability of the analysis datas.The results show that the sperm analyzer could correctly identify sperm and non-sperm,effectively track the movement of sperm,and accurately calculate the software.Through the 3Q verification of the sperm analyzer,the sperm analyzer has excellent performance in all aspects,which can be used to evaluate the morphological and kinetic indexes of sperm.