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台湾实施通用微量混合核酸检测后献血者感染谱及输血传播人类免疫缺陷病毒、丙型肝炎病毒和乙型肝炎病毒残余风险的趋势

Trends in donor infection profiles and residual risks of transfusion-transmitted human immunodeficiency virus, hepatitis C virus and hepatitis B virus after the implementation of universal mini-pool nucleic acid testing in Taiwan.

作者信息

Liu Wen-Jie, Yu Ching-Mei, Chen Yun-Yuan, Chen Jen-Wei, Wei Sheng-Tang, Hou Sheng-Mou

机构信息

Taiwan Blood Services Foundation, Taipei, Taiwan.

Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.

出版信息

Vox Sang. 2025 Aug 6. doi: 10.1111/vox.70083.

Abstract

BACKGROUND AND OBJECTIVES

Universal mini-pool nucleic acid testing (NAT) for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV) in blood donations has been introduced in Taiwan since 2013. This study aimed to evaluate changes in donors' infection profiles and residual risks of transfusion-transmitted infections (TTIs) for these viruses after NAT implementation.

MATERIALS AND METHODS

Donations from 15 January 2013 to December 2023 were included in this study. Residual risks associated with the window period (WP) and occult HBV infection (OBI) were both estimated.

RESULTS

Among 19,756,973 donations, 465, 5592 and 23,534 were confirmed positive for HIV, HCV and HBV, respectively. A high proportion of HBV-positive donations was NAT-yield donations (19.5%), particularly among repeat donors (61.3%). Donor prevalences for these viruses declined regardless of first-time or repeat donors. The residual risks of WP per million donations in 2022-2023 were estimated at 0.08 (95% confidence interval [CI]: 0.02-0.17) for HIV-TTI, 0.31 (95% CI: 0.24-0.55) for HCV-TTI and 26.38 (95% CI: 12.81-50.06) for HBV-TTI, with significant declining trends for HIV-TTI and HBV-TTI since universal NAT implementation. The residual risk of OBI was relatively high yet decreasing, accounting for more than half of the total residual risk for HBV-TTI in 2022-2023.

CONCLUSION

After NAT implementation in Taiwan, prevalences and residual risks of TTI for HIV, HCV and HBV have declined. Although the residual risk of HBV-TTI remains relatively high, it is comparable to that in other endemic areas, and no cases of TTI from these viruses have been reported since NAT implementation.

摘要

背景与目的

自2013年起,台湾地区开始对献血者进行人类免疫缺陷病毒(HIV)、丙型肝炎病毒(HCV)和乙型肝炎病毒(HBV)的通用微型混合核酸检测(NAT)。本研究旨在评估核酸检测实施后献血者感染谱的变化以及这些病毒的输血传播感染(TTI)残余风险。

材料与方法

本研究纳入了2013年1月15日至2023年12月的献血样本。同时评估了与窗口期(WP)和隐匿性HBV感染(OBI)相关的残余风险。

结果

在19,756,973份献血样本中,分别有465份、5592份和23,534份被确认为HIV、HCV和HBV阳性。HBV阳性献血样本中很大一部分是核酸检测检出的(19.5%),在多次献血者中尤为突出(61.3%)。无论初次献血者还是多次献血者,这些病毒的献血者感染率均有所下降。2022 - 2023年每百万份献血中HIV-TTI的窗口期残余风险估计为0.08(95%置信区间[CI]:0.02 - 0.17),HCV-TTI为0.31(95% CI:0.24 - 0.55),HBV-TTI为26.38(95% CI:12.81 - 50.06),自通用核酸检测实施以来,HIV-TTI和HBV-TTI的残余风险呈显著下降趋势。OBI的残余风险相对较高但呈下降趋势,在2022 - 2023年占HBV-TTI总残余风险的一半以上。

结论

台湾地区实施核酸检测后,HIV、HCV和HBV的TTI感染率和残余风险均有所下降。虽然HBV-TTI的残余风险仍然相对较高,但与其他流行地区相当,自核酸检测实施以来尚未报告这些病毒导致的TTI病例。

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