京津冀血站实验室核酸单检模式鉴别阳性率分析

Discriminatory positive rate of individual donor-nucleic acid test mode of blood station laboratories in the Beijing-Tianjin-Hebei Region

目的对京津冀血站实验室单人份核酸检测(ID-NAT)模式鉴别阳性率进行分析,探讨导致不同血站实验室鉴别阳性率差异的可能原因以及消除差异应采取的措施,为实现京津冀血液筛查实验室检测质量同质化奠定基础。方法根据《京津冀血站实验室质量监控指标调查表》收集2018年1~12月京津冀A、B、C、D 4家血站血液筛查实验室进入ID-NAT系统的联检阳性标本数及鉴别阳性标本数,并根据ELISA检测结果,将联检阳性标本分为单阳标本(ELISA阴性NAT阳性)及双阳标本(ELISA阳性NAT阳性)。分析比较A、B、C 3家血站实验室各自不同月份间总体鉴别阳性率的变化。分析比较A、B、C 3家血站实验室NAT单检总体鉴别阳性率、双阳标本鉴别阳性率、单阳标本与双阳标本鉴别阳性率的不同,比较A、B、C、D 4家血站实验室NAT单阳标本鉴别阳性率的不同。结果A、B、C 3家血站实验室2018年1~12月不同月份间总体鉴别阳性率自我比较均明显不同(P<0.05),A血站实验室最高鉴别阳性率为91.67%,最低为65.88%;B血站实验室最高鉴别阳性率为72.73%,最低为21.05%;C血站实验室最高鉴别阳性率为80.39%,最低为7.69%;A、B、C 3家血站实验室的总体鉴别阳性率和双阳标本鉴别阳性率均有差异(P<0.05);A、B、C、D 4家血站实验室的NAT单阳标本鉴别阳性率也有差异(P<0.05);A、B 2家血站实验室的双阳标本鉴别阳性率95.97%和85.25%均明显大于单阳标本的鉴别阳性率36.36%和30.71%(P<0.05),但C血站实验室的双阳标本鉴别阳性率32.63%却明显小于单阳标本鉴别阳性率44.39%(P<0.05)。结论2018年京津冀血站实验室NAT单检总体标本鉴别阳性率、单阳标本鉴别阳性率、双阳标本鉴别阳性率、同一血站实验室不同月份的单检标本鉴别阳性率均存在明显差异。应分析探讨导致这种差异的原因并寻求解决方案,以达到京津冀血站实验室检测质量同质化的目的。

Objective To analyze the discriminatory positive rate(DPR)of individual donor-nucleic acid test(ID-NAT)mode of blood screening laboratories in the Beijing-Tianjin-Hebei Region,explore the possible reasons for DPR differences among blood station laboratories and the measures to lesson the differences,in order to lay a foundation for realizing the homogenization of detection quality of blood screening laboratories in Beijing-Tianjin-Hebei Region.Methods The number of triplex-positive samples and discriminatory-positive samples of A,B,C,and D blood station laboratories,which submitted to ID-NAT system,in Beijing-Tianjin-Hebei Region from January to December 2018 were collected by a questionnaire of Quality Supervise Index of Blood Station Laboratories in Beijing-Tianjin-Hebei Region.The triplex-positive samples were divided into solo-positive samples(NAT;ELISA;)and dual-positive samples(NAT;ELISA;).The changes of total DPR of A,B and C blood screening laboratories in different months was analyzed and compared respectively.The differences of total DPR of ID-NAT,DPR of NAT;ELISA;samples,and DPR between NAT;ELISA;samples and NAT;ELISA;samples of A,B,and C blood screening laboratories during January 2018 to December 2018 was analyzed and compared.The difference of DPR of NAT;ELISA;samples among A,B,C,and D blood station laboratories was also compared.Results Significant difference in total DPR was noticed in different months of A,B,and C blood station laboratories from January to December 2018(P<0.05),with the highest DPRs of A,B and C laboratory at 91.67%,72.73%.and 80.39%,the lowest DPRs at 65.88%,21.05%,and 7.69%,respectively.Significant statistical differences in the total DPR and the DPR of NAT;ELISA;samples were found among A,B,and C blood station laboratories(P<0.05).Significant statistical differences in the DPR of NAT;ELISA;samples were found among A,B,C,and D laboratories(P<0.05).The DPR of NAT;ELISA;samples of A and B blood station laboratories(95.97%and 85.25%)were significantly higher than those of NAT;ELISA;samples(36.36%and 30.71%)(P<0.05).However,the DPR of NAT;ELISA;samples of C blood station laboratory(32.63%)was significantly lower than that of NAT;ELISA;samples(44.39%)(P<0.05).Conclusion There were significant differences in the total DPR,the DPR of NAT;ELISA;samples and NAT;ELISA;samples that were detected by ID-NAT system in 2018 among blood station laboratories in the Beijing-Tianjin-Hebei Region,and the total discriminatory positive rate in different months was also different for the same blood station.It is necessary to explore the reasons leading to the differences and seek solutions in order to achieve the homogenization of detection quality of blood screening laboratories in Beijing-Tianjin-Hebei Region.