酶法测定游离脂肪酸液体试剂盒的稳定性评价

A Stability Evaluation of Liquid Kit for the Determination of Free Fatty Acids by Enzymatic Method

目的评估北京九强生物技术股份有限公司(简称九强)和德国德赛诊断系统有限公司(简称德赛)的酶法游离脂肪酸(FFA)试剂盒的效期稳定性、开瓶稳定性以及热加速稳定性。方法取出两个厂家的三批试剂后同时定标,分别测定其批内不精密度、线性范围、开瓶稳定性和热加速稳定性。结果九强和德赛各批次试剂配套质控品的偏倚均小于5%,质控品及低、中、高浓度血清样本的批内不精密度CV均小于5%;九强和德赛试剂线性范围分别是0.1~2mmol/L和0.01~3mmol/L;九强和德赛试剂在开瓶监测期前后测定质控累计偏差分别为4.26%、8.88%(朗道质控水平1)和5.19%、-1.43%(朗道质控水平2)。结论九强和德赛试剂实时稳定性良好,在效期内各批次包括接近效期末批次的试剂正确度、批内不精密度、线性范围都可满足厂商制定的性能指标要求。两种试剂开瓶稳定性都较好,在机开瓶可稳定4周,但九强试剂比德赛试剂具有更长的有效期,可达18个月。

Objective To evaluate the efficacy stability,open bottle stability and thermal acceleration stability of enzymatic free fatty acid(FFA)kits from Beijing Strong Biotechnologies(BSBE)and DiaSys Diagnostics Systems GmbH(DiaSys).Methods Three batches of reagents from two companies were obtained and calibrated at the same time.The intra-batch imprecision,linear range,bottle opening stability and thermal acceleration stability were determined respectively.Results The bias of each batch of reagents in BSBE and DiaSys was less than 5%and the in-batch imprecision CV of the quality control product and serum of each level were all less than 5%.The linear ranges of BSBE and DiaSys were 0.1-2mmol/L and 0.01-3mmol/L,respectively.The accumulative deviations of the quality control product before and after bottle opening were 4.26%,8.88%(Landau level 1)and 5.19%,-1.43%(Landau level 2)respectively.Conclusion The stabilities of BSBE and DiaSys are good,and the accuracy of each batch,the intra-batch imprecision and the linear range can meet the performance requirements established by the manufacturer during the effective period.The bottle opening stabilities of the two reagents can maintain for 4 weeks in the machine.The reagent of BSBE has a longer period of validity than that of the DiaSys,which can reach 18 months.