摘要
根据不同荧光定量PCR仪器品牌的市场占有率挑选了不同型号、不同工作频率和使用年限的仪器进行校准和质量风险分析,重点针对温度示值误差、温度均匀度、样本重复性和样本线性四个技术指标作了检测和比较,探讨了这四个技术指标出现偏差可能造成的检测结果失准的风险,并对仪器生产厂商和仪器使用者提出了建议.通过分析评估得出了该类仪器应该重点关注的技术参数指标和技术难点,为仪器使用者了解该产品的质量状况及相关政策措施的制定提供了参考依据.
Abstract
This article selected different models,working frequencies,and usage periods of instruments based on the market share of different PCR instrument brands for calibration and quality risk analysis.It focused on four technical parameters,including temperature indication error,temperature uniformity,sample repeatability,and sample linearity,to conduct testing and comparison.The article discussed the risks of measurement result inaccuracies caused by deviations in these four technical indicators and provided suggestions for instrument manufacturers and users.The results showed that through analysis and evaluation,this article identified the key technical parameters and challenges that the instrument should focus on,providing a reference basis for instrument users to understand the quality status of the product and the formulation of relevant policy measures.
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