部分国产生化试剂质量评估与应用

Performance evaluation of some domestically produced biochemical reagents

目的对5个厂家40种临床生化试剂进行性能评价,评价其临床应用价值。方法在Beckman AU5400全自动生化分析仪上对四川迈克、宁波美康、复兴长征3家国产厂家和罗氏、日本日立两个进口厂家的40种临床常用生化项目试剂进行性能验证。分析样本分别选取2021年12月至2022年6月在南京鼓楼医院进行临床检测的患者血清。参照中国国家卫生行业标准、中国国家医药行业标准、美国临床实验室标准化协会(CLSI)对体外诊断试剂性能评价标准、中国国家食品药品监督管理局关于体外诊断试剂管理相关规定中推荐的方法对40种试剂的精密度、线性范围、开瓶稳定性、不同批次校准品互换性及正确度进行评估和验证。线性回归采用简单线性回归分析。结果40种试剂的精密度良好,除一种国产试剂低水平批内变异系数超出说明书声明范围外,其余试剂的批内、批间变异系数均小于各自说明书中声明的数值。国产试剂及进口试剂的线性范围均达到了各厂家声明的线性范围。40种试剂开瓶30 d与相应新试剂测量值之间差异均无统计学意义(P>0.05)。国产试剂与进口试剂经不同批次校准品互换后检测结果均在各厂家声明的范围内。国产试剂与进口试剂正确度评价良好。结论3个国产厂家的27个生化检测数据的各项性能指标基本与进口试剂一致,可满足临床生化实验室的要求,但部分检测试剂的开瓶稳定性及抗干扰性仍需进一步改进。

Objective To evaluation the performance of a total of 40 clinical biochemical reagents from three domestic manufacturers and two foreign manufacturers,and evaluate their clinical application value.Methods The Beckman AU5400 automatic biochemical analyzer was used to verify the performance of 40 kinds of commonly used clinical biochemical reagents from three domestic manufacturers of Sichuan Maccura,Ningbo Medical System,and Shanghai Fosun Long March,and two foreign imported manufacturers of Roche and Japan′s Hitachi.The analysis samples were selected from the serum of patients who underwent clinical testing in Nanjing Drum Tower Hospital hospital from December 2021 to June 2022.Refer to China′s national health industry standards,China′s national pharmaceutical industry standards,the US Clinical Laboratory Standards Institute(CLSI)for the performance evaluation standards of in vitro diagnostic reagents,and the methods recommended in the relevant regulations of China′s State Food and Drug Administration on the management of in vitro diagnostic reagents.The precision,linear range,open bottle stability,interchangeability of calibrators and accuracy from different batches of 40 reagents were evaluated and validated.Simple linear regression analysis was used for linear regression,and P<0.05 indicated that the regression was statistically significant.Results The overall precisions of 40 reagents were fine,except for one domestic reagent with low-level intra-batch coefficient of variation(CV)exceeding the range declared in the specification.The intra-and inter-batch CVs of the remaining reagents were all smaller than those declared in their respective specifications.The linear ranges of domestic reagents and imported ones have achieved the linear ranges declared by each manufacturer.There were no statistical differences on the measurements between the reagents from open bottle of 30 days and the corresponding new ones for 40 reagents(P>0.05).The test values of domestic reagents and imported reagents after exchange of different batches of calibrators were within the ranges declared by each manufacturer.Both domestic reagents and imported reagents have passed the accuracy verification.Conclusions The performance index of 27 biochemical detection indicators of the three domestic manufacturers are basically consistent with those of imported reagents,meeting the requirements of clinical biochemical laboratories.However,the bottle opening stability and anti-interference performance of some detection reagents needs to be improved.