临床免疫检验影响因素及质量控制分析

Analysis of influencing factors and quality control of clinical immunoassay

目的:分析临床免疫检验影响因素,并探讨质量控制对策。方法:选取2015年11月-2019年12月进行肺炎衣原体或EB病毒抗体检验结果为阳性或假阴性的报告100份,对影响临床免疫检验质量的因素进行多重性回归分析。同时选取同期实施相同项目检验的患者100例,其中对照组50例给予常规检验;试验组50例给予质量控制检验;对比实施质量控制后的检验效果。结果:经分析发现,影响临床免疫检验质量的主要因素包括检验人员操作水平、样本质量、试剂平衡时间、检验仪器清洁度、存储环境的温度与湿度等。给予实施质量控制后的检验效果显示,试验组结果为阳性或假阴性的发生率显著低于对照组,差异有统计学意义(P<0.05)。结论:影响临床免疫检验质量的因素较多,临床需针对影响因素制定相应的质量控制措施,为临床医生诊断疾病提供最为可靠的依据。

Objective:To analyze the influencing factors of clinical immunoassay and discuss quality control strategies.Methods:From November 2015 to December 2019,100 cases of positive or false negative reports of chlamydia pneumoniae or EB virus antibodies were selected,a multiple regression analysis was performed on the factors that affected the quality of clinical immunoassay.At the same time,100 cases of patients with the same item were selected,among them,50 cases in the control group were given conventional tests and 50 cases in the test group were given quality control tests.The effect after implemented the quality control test was compared.Results:It was found that the main factors that affected the quality of clinical immunoassay included the operational level of inspection personnel,sample quality,reagent balance time,cleanliness of the test instrument,temperature and humidity of the storage environment,etc.The results of different inspection methods showed that,the incidence rate of positive or false negative in the test group was significantly lower than that in the control group,the difference was statistically significant(P<0.05).Conclusion:There are many factors that affect the quality of clinical immunoassay,quality control measures should be made according to the influencing factors to provide the most reliable basis for clinicians to diagnose diseases.