Study On Blood-Screening Strategy For Reducing The Risk Of Transfusion-Transmitted Pathogens In China

Study on Blood-Screening Strategy for Reducing the Risk of Transfusion-Transmitted Pathogens in ChinaBackgroundBlood transfusion is a double-edged sword.While saving patients lives,it may also spread pathogens.Establishing a suitable blood-screening strategy system is an important measure to ensure national blood safety.A reasonable blood-screening strategy system should be constantly updated with the development of economics and technology,as well as the change of the epidemic situation of pathogens.In recent years,the Chinese government has paid more attention to blood safety and invested more in it.However,the transmission of pathogens by blood transfusion still occurs every year,and the transmission of pathogens caused by clinical blood transfusion cannot be underestimated.At present,there are only four kinds of pathogens in routine blood screening in China.Because of the continuous emergence of new and recurrent pathogens,the continuous development of detection technologies,and the complaints of blood donors continues to occur for the false positive results of screening,as well as the related problems resulting there from.This presents a severe challenge in China.On the basis of the current research situations at home and abroad,and combined with the previous research foundation of our group,this study establishes a Cost-Effectiveness model with HTLV,evaluates the blood-screening strategies for new and recurrent pathogens,evaluates the risks of new blood-screening strategies for routine screening of pathogens with HCV and HBV as examples,and carries out multi-center experimental studies for screening reactive blood donors,establishes a re-entry model,and lets false positive blood donors re-donate,to ensure adequate and safe blood supplies.Research Contents and Methods1.HTLV screening strategy:In cooperation with 20 blood centers in 13 provinces and municipalities,samples of volunteer blood donors were collected from 2016 to 2017,and HTLV antibodies were screened by ELISA.If results were reactive,complementary experiments were performed by RIBA,and information of blood donors with HTLV antibodies positive was collected.In collaboration with Fujian Union Medical College Hospital,we collected blood samples of leukemia patients,tested HTLV antibody.If HTLV antibody confirmed positive,patients,family history and infection in families was tracked,and basic information was collected on patients.In addition,the information of HTLV screening and demographic characteristics of blood donors with HTLV antibody confirmed positive in Xiamen blood center from 2014 to 2017 were collected,and the information of blood donors rin Hefei Blood center and blood recipients in Hefei area in 2016 were collected to establish the Cost-Effectiveness model.2.HCV and HBV screening strategy:In 2017,samples of voluntary blood donors from Changzhi blood center were randomly collected.HCV antibodies were detected simultaneously with ELISA reagents from five manufacturers,and HCV-RNA was detected with a nucleic acid reagent.In 2017,samples of volunteer blood donors from Changchun blood center were randomly collected.HBsAg was detected simultaneously with five manufacturers’ ELISA reagents and HBV-DNA was detected with a nucleic acid reagent.If necessary,the infection status of blood donors wasconfirmed and traced,and evaluated for the risk of HCV and HBV and missed detection under different screening strategies.3.Study on the strategy of blood donors re-entry:Collecting donors’ samples with screening reactive from January 2016 to December 2018 in cooperation with 15 blood centers.After following-up and confirmation,the infection status of blood donors was judged,and the re-entry models was established for four pathogens of HIV,HCV,HBV and Treponema pallidum.Results1.A total of 875,453 samples were collected for HTLV screening,and 22 samples were HTLV antibody confirmed positive by WB.The prevalence of blood centerwere(1/100000):11.09 in Xiamen,2.88 in Shenzhen,3.16 in Beijing,5.96 in Changsha and 0.98 in Nanjing,respectively.The remaining 15 blood centers(including Shenyang,Dalian,Xuzhou,Ma’anshan,Bengbu,Hefei,Anqing,Wuhu,Suzhou,Changzhi,Hainan,Nanchong,Deyang,Urumqi and Iri)showed no positive results.Most of the HTLV antibody positive donors were first-time blood donors.The Cost-Effectiveness model of HTLV was successfully established.When the prevalence of HTLV among blood donors was more than 8/100000,it was more economical and reasonable to carry out HTLV detection.2.HCV screening was carried out in 10,000 samples.29 of them were ELISA-reactive.Of these 29,five were confirmed to be Anti-HCV positive(all five ELISA results were positive for each sample),14 were negative,and 10 donors were not successfully followed-up with,so their infection status could not be judged.HBV screening was carried out in 9951 samples.There were 58 ELISA reactivity,of which,12 were proven to be infected with HBV.Among the 12 samples,one of the J reagents was missed,but its nucleic acid results were positive;three of the L reagents were missed,but only two of them were NAT positive and one was NAT negative.3.A total of 727 HIV,2083 HCV,1825 HBV and 877 TP samples were collected from screening reactive donors.After follow-up and confirmation,95 donors were shown HIV antibody positive and 291 were negative;201 donors were HCV antibody positive and 974 were negative;405 donors were HBsAg and/or HBV-DNA positive and 427 were negative;407 TP antibody were positive and 275 were negative.The other donors were lost during the follow-up process for various reasons and their infection status could not be confirmed,so they were abandoned in the study.According to the confirmation procedures and experimental results of this study,the corresponding re-entry model is established.Conclusion1.When the prevalence of HTLV among blood donors is greater than 8/100000,it is necessary to carry out HTLV testing;areas with prevalence of HTLV less than 8/100000 can decide whether to carry out HTLV testing according to their own conditions.Screening for first-time donors alone does not significantly increase the risk of HTLV transmission through blood transfusion.2.Choosing any combination of one ELISA reagent and one nucleic acid reagent to screen HCV will not significantly increase the residual risk of HCV.If we choose a combination of one ELISA reagent and one nucleic acid reagent to screen HBV,the J and L ELISA reagents have a certain risk of missed detection,but L reagent has a higher risk of missed detection.3.Based on the results of confirmation and follow-up,this study establishes a confirmation and re-entry program to ensure that positive donors are permanently shielded,and negative donors who meet the conditions of blood donation can return to the team,and the rights and interests of blood donors and their physical and mental health can be guaranteed.