华支睾吸虫病快速诊断试剂盒质量控制10年分析

Ten Years Analysis of the Quality Control of Fast-ELISA Diagnostic Kit for Clonorchis sinensis

目的 建立华支睾吸虫病快速诊断试剂盒的质量控制体系,并以此对试剂盒进行质量监控。方法 建立了由200份确诊病人血清混合而成的阳性质控品和由200份非流行区健康人血清混合而成的阴性质控品,确定了包括对阳性质控品和阴性质控品的检测标准。结果 对10年104批次共101万人份的诊断试剂盒进行了监测,阳性质控品和阴性质控品的平均吸光度值分别为0.444和0.066,总阳性质控品和总阴性质控品变异系数分别为7.60％和10.72％。结论 华支睾吸虫病快速诊断试剂盒具有高度的敏感性、特异性和稳定性,质量监测体系也是一种性能可靠、行之有效的质量控制方案。

Objective To establish a quality control system for clonorchiasis sinensis fast ELISA diagnostic kit and to monitor the quality of the kit with this system. Methods The positive control was prepared by mixing 200 serum samples of patients infected with Clonorchis sinensis while the negative control was prepared by mixing 200 sernn samples of health persons from un-epidemic areas. A quality standard was set. Results All 1.01 million tests in 104 lots of the diagnostic kits were monitored with the quality control method. The mean positive and negative absorbance(A) were 0.444 and 0.066 respectively while the total positive controls and negative controls coefficient of variation(CV) were 7.60% and 10.72% respectively. Conclusion This kit is proved as a sensitive, specific and stable diagnostic tool for clonorchiasis sinensis and such a quality control method can be regarded as an excellent quality control model as well.