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Objective To explore the gender and age characteristics of Hepatitis E virus seroprevalence in Chinese voluntary blood donors by Meta-analysis, so as to evaluate the prevalence of HEV and provide reference for blood donor recruitment and HEV screening. Methods Databases such as CNKI, Wanfang Medicine and PubMed were searched by keywords or subject words, and the eligible literature were extracted for Meta-analysis of Hepatitis E virus seroprevalence by gender and age using R4.1.3 software. Results 1) A total of 15 gender related literature were obtained, of which 14 involved anti-HEV IgG, containing 38 203 males and 25 760 females, with pooled estimated positive rate of anti-HEV IgG as 24.54%[95% CI(17.32%, 32.56%)] and 19.52%[95% CI(11.71%, 28.76%)], respectively(P>0.05); 13 involved anti-HEV IgM, containing 46 125 males and 33 345 females, with pooled estimated positive rate of anti-HEV IgM as 1.16% [95% CI(0.93%, 1.40%)] and 0.84% [95% CI(0.54%, 1.20%), respectively(P>0.05); 2) A total of 12 age related literature were obtained, of which 11 involved anti-HEV IgG: 0.05). Conclusion There was a certain amount of HEV carriers among Chinese voluntary blood donors and the prevalence of HEV in different regions showed different distribution characteristics by gender and age. No difference was found in the prevalence of HEV among voluntary blood donors by gender. The past infection rates of HEV among voluntary blood donors ≥30 years old was higher than those

Objective To analyze the serological markers and RNA prevalence of HEV infection in Chinese voluntary blood donors in different regions of China, so as to provide basis for the necessity of HEV screening and the formulation of screening strategies for voluntary blood donors. Methods Databases such as CNKI, Wanfang medicine and PubMed were searched for eligible literature, and the literature data meeting the inclusion criteria were extracted for meta-analysis using R4.1.3 software. Results A total of 26 studies were included, involving 97 928, 117 831 and 82 673 cases, respectively, for anti-HEV IgG, anti-HEV IgM and HEV RNA. The pooled estimated prevalence of anti-HEV IgG, anti-HEV IgM and HEV RNA among Chinese voluntary blood donors was 23.0% [95% CI (18%, 29%)] vs 1.13% [95% CI (0.94%, 1.36%)] vs 0.028%[95%CI(0.006%, 0.059%)], and there were significant differences among different cities and regions. Conclusion The past infection rate of HEV among voluntary blood donors in China was somewhat high and with significant regional differences. The current infection rate was relatively low and had decreased compared with that in the past decade, but there was still residual risk of blood transfusion. It is necessary to pay more attention to blood HEV screening of voluntary blood donors.

Objective To analyze the status of HBV infection in blood donors reactive to jointed NAT but non-reactive to primary discriminatory tests (NRR), so as to provide suggestions and data support for subsequent studies on NRR samples. Methods HCV RNA and HIV RNA repeat differential detection, HBV DNA viral load detection and HBV pgRNA copy volume detection were performed in the plasma of 60 blood donors with negative ELISA results in routine blood screening and NRR in NAT. HBsAg, HBsAb, HBcAb, HBeAg and HBeAb serological tests were performed on the NRR samples with positivity in HBV DNA viral load and HBV pgRNA virus copy detection, so as to analyze the serological infection status and occult hepatitis B (OBI) infection. Results The HCV RNA and HIV RNA repeat discrimination results of 60 NRR samples were negative. The quantitative detection results of HBV DNA in 60 NRR samples were positive in 9 cases (15%), and the HBV DNA concentration was less than 10IU/mL. Nine cases (15%) were positive for HBV pgRNA quantitative detection, and the virus copy volume x-±SD was (289±58.25) copies/mL. Two NRR samples (3.33%) were HBV DNA positive and HBV pgRNA positive. Among the 9 HBV-DNA positive samples, the highest positive rate of HBcAb was 66.67%, and 7 (77.78%) of them were confirmed to be seropositive for OBI. Among the 9 HBV pgRNA positive samples, the copy amount of pgRNA in HBcAb positive samples was slightly higher than that in negative samples, while the copy amount of pgRNA in HBsAb and HBeAb positive samples was lower than that in corresponding negative samples. In recent 6 years, the proportion of NRR samples in the single NAT system of the center fluctuated from 0.09% to 0.13%. Conclusion HBV DNA and HBV pgRNA exist in NRR samples. HBV DNA and/or HBV pgRNA positive samples can be detected in the relevant serological infectious markers. NRR samples have a certain potential risk of OBI infection. HBV DNA detection plus HBV pgRNA can better confirm the status of virus infection in NRR and improve the safety of blood transfusion.

Objective To analyze the profile, preliminary screening and laboratory test results of voluntary blood donors in the past five years, so as to provide basis for formulating the recruitment strategy, ensuring clinical blood use and improving blood safety and quality. Methods 789 570 voluntary blood donors from 2016 to 2020 were classified according to the category, and the positive rate of blood testing results was statistically analyzed. Results The proportion of transfusion-transmitted infections (TTI), including HBsAg, anti-HCV, anti-T, and anti-HIV, was led by HBsAg, except for anti-TP leading in 2018. The positive rate of ELISA items and ALT tests showed statistical significance by age groups(P0.05). The positive rate of preliminary screening and laboratory testing showed differences among occupation and educational background(P0.05). The number of HIV positive males (n=228) was higher than that of females(n=3), and the proportion of workers (23.08%~40.74%) and staff (16.67%~46.67%) were large. In 2020, however, the proportion of HIV infected students increased sharply to 21.62%. Sole HBV DNA positive cases was the most (n=460), while the number of sole HIV RNA(n=3) and HCV RNA positive cases (n=6) were rather low. Conclusion Targeted recruitment strategies should be formulated according to the profile and test results of voluntary blood donors to further improve blood test ability and ensure blood safety.

Objective To evaluate the laboratory's NAT ability by analyzing the feedback reports of nucleic acid test (NAT) results of external quality assessment (EQA) of National Center for Clinic Laboratories (NCCL), so as to improve the laboratory management details and ensure blood safety. Methods The data of NCCL NAT EQA of blood screening laboratory of Tianjin Blood Center (a total of five occasions from Jan 2019 to Jun 2021) were statistically analyzed. Results From Jan 2019 to Jun 2021, the laboratory participated in EQA for five times and all the results were qualified. The test results of NAT EQA HIV RNA/HCV RNA/HBV DNA detected by R1, R2 and R4 were consistent with the reference results. R3 showed false positive results (CT value 40.46) in the single donation detection of sample No.1925 in HCV RNA. Unreported data of the laboratory was that in the first EQA in 2021, the R4 showed false positive results (CT value 35.8) in in the single donation detection of sample No.2113 in HIV RNA. Conclusion The performance of each NAT screening system in our laboratory is relatively stable except occasional false positive results influenced by every factor. Potential problems can be found and continuously improved by assaying EQA reports and the extended experimental results of EQA samples to further improve the detection ability.