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2016—2025年莆田市无偿献血人群血液筛查结果分析
Blood screening results of voluntary blood donors in Putian from 2016 to 2025
目的 分析2016—2025年莆田市无偿献血人群经血液传播病原体感染状况，为优化血液筛查策略提供依据。方法 收集2016年3月1日至2025年12月31日莆田市无偿献血的血液样本，采用酶联免疫吸附试验（enzyme-linked immunosorbent assay, ELISA）检测乙型肝炎病毒（hepatitis B virus, HBV）表面抗原、丙型肝炎病毒（hepatitis C virus, HCV）抗体、人类免疫缺陷病毒（human immunodeficiency virus, HIV）抗体、梅毒螺旋体（treponema pallidum, TP）抗体及人类T淋巴细胞白血病病毒（human T-lymphotropic virus, HTLV）抗体；对其中部分样本同时进行核酸检测（nucleic acid tests, NAT），靶标为HBV DNA、HCV RNA和HIV RNA。采用Joinpoint回归模型分析阳性率时间趋势。结果 2016年3月1日至2025年12月31日莆田市共收集献血样本240 306份，所有样本均接受ELISA检测，235 646份样本同时接受了NAT。ELISA筛查5种病原体总阳性率为15.21‰（3 655/240 306），HBV、HCV、HIV、TP、HTLV阳性率分别为7.59‰、2.90‰、0.15‰、4.23‰、0.32‰。NAT筛查3种病原体总阳性率为3.33‰（784/235 646），HBV DNA、HCV RNA、HIV RNA阳性率分别为3.28‰、0.02‰、0.04‰。Joinpoint回归分析显示，2016—2025年ELISA检测总阳性率整体呈上升趋势，AAPC为2.25%（95%CI：0.81%~3.64%），其中2022—2025年呈上升趋势，APC为10.95%（95%CI：5.51%~19.06%）；2016—2025年NAT总阳性率整体呈下降趋势，AAPC为-5.68%（95%CI：-9.91%~-2.08%），其中2016—2021年呈下降趋势，APC为-12.51%（95%CI：-28.82%~-4.53%）。结论 莆田市献血人群血液样本存在一定程度的病原体感染，ELISA检测与NAT结果的波动特征存在差异，应加强两者联合检测，确保献血安全。
Objective To analyze the infection status of bloodborne pathogens among voluntary blood donors in Putian from 2016 to 2025, and to provide evidence for optimizing blood screening strategies. Methods Blood samples from voluntary blood donors in Putian City from March 1, 2016 to December 31, 2025 were collected. Enzyme-linked immunosorbent assay (ELISA) was used to detect hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, Treponema pallidum (TP) antibody, and human T-lymphotropic virus (HTLV) antibody. Some of the samples were simultaneously tested for nucleic acid testing (NAT) targeting HBV DNA, HCV RNA, and HIV RNA. Joinpoint regression model was used to analyze the temporal trend of positive rates. Results A total of 240 306 blood samples were collected from blood donors in Putian City from March 1, 2016 to December 31, 2025. All samples were tested by ELISA, and 235 646 samples were also tested by NAT. The total positive rate of the five pathogens screened by ELISA was 15.21‰ (3 655/240 306), with positive rates of HBV, HCV, HIV, TP and HTLV being 7.59‰, 2.90‰, 0.15‰, 4.23‰ and 0.32‰, respectively. The total positive rate of the three pathogens screened by NAT was 3.33‰ (784/235 646), with positive rates of HBV DNA, HCV RNA and HIV RNA being 3.28‰, 0.02‰ and 0.04‰, respectively. Joinpoint regression analysis showed that the overall ELISA positivity rate showed an upward trend from 2016 to 2025, with an average annual percent change (AAPC) of 2.25% (95%CI: 0.81% to 3.64%). A particularly significant upward trend was observed from 2022 to 2025, with an annual percent change (APC) of 10.95% (95%CI: 5.51% to 19.06%). In contrast, the overall NAT positivity rate from 2016 to 2025 showed a downward trend, with an AAPC of -5.68% (95%CI: -9.91% to -2.08%). A marked downward trend was observed from 2016 to 2021, with an APC of -12.51% (95%CI: -28.82% to -4.53%). Conclusion The blood samples from blood donors in Putian exhibit a certain degree of pathogen infection. There are differences in the fluctuation characteristics between ELISA and NAT results, and combined testing with these two methods should be strengthened to ensure blood donation safety.
无偿献血 / 酶联免疫吸附试验 / 核酸检测 / 病原体筛查 / 用血安全
Voluntary blood donors / ELISA / NAT / Pathogen screening / Blood safety
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Background: Human T-cell lymphotrophic virus type 1 (HTLV-1) has a worldwide distribution and it is endemic in some regions of Iran. One of the most important routes of HTLV-1 transmission is via transfusion of contaminated blood components. The risk of transmission through asymptomatic blood donors, particularly in endemic areas should be considered and appropriately managed. The main objective of this study was to determine the seroprevalence and description the geographic distribution of HTLV-1 among voluntary blood donors in Iran.Methods: This retrospective study carried out using the data obtained from the main database of the seven blood transfusion centers of Iranian Blood Transfusion Organization between 2009 and 2013. The presence of anti-HTLV-1/2 antibodies were primarily assessed using Enzyme-linked Immunosorbent Assay. The Ab Kit assay, contain antigens for the screening of antibodies to HTLV type 1 and 2. So, it is expressed as HTLV 1/2 assay. Samples that were positive by the western blot confirmatory test were considered as definite positive HTLV-1 or HTLV-2 cases. The main socio-demographic variables were; age, gender, donation history and marital status. Descriptive and analytical statistics were used to summarize the gathered data. The chi-Square Statistical test was used to test the association between groups, P-value of less than 0.05 was considered significant.Results: A total of 1864489 blood donations were evaluated. There were 1840 confirmed HTLV-1 positive donations (0.098%). None were positive for anti-HTLV-2. The overall HTLV-1 prevalence was 98.7 per 100,000 donations during the 5 year period. Seroprevalence was higher among females, married and older blood donors. The overall seropositivity among first time, regular and lapsed donors was, 0.29% (290/100000), 0.001% (1/100000) and 0.02% (20/100000) respectively. A significant difference was observed between regular and the first time (p < 0.0001) and also between lapsed and regular blood donors (p < 0.0001). Most of the HTLV-1 seropositive blood donors (175 per 100,000) were from northeastern regions. We observed a gradual decline in overall HTLV-1 prevalence during the course of the study, the prevalence rate decreased from 0.13% (130/100000) in 2009 to 0.07% (70/100000) in 2013.Conclusions: The Seroprevalence of HTLV-1 among Iranian blood donors in the regions of our study still is considerable, but there is an obvious declining prevalence over the course of present study. Blood transfusion centers should continually evaluate the residual risk of infection in the country, especially in endemic areas.
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