台灣實施捐血者核酸試驗十年經驗與輸血安全成效

過去捐血者傳染病原篩檢主要以血清免疫試驗來檢測，以人類免疫缺乏病毒(human immunodeficiency virus, HIV)、C型肝炎病毒(hepatitis C virus, HCV)與B型肝炎病毒(hepatitis B virus, HBV)為最重要，自2013年1月15日起，我們對捐血者全面加測核酸試驗(nucleic acid testing, NAT)，大幅縮短檢驗空窗期。NAT實施至今已屆十年，本研究欲評估實施捐血者NAT篩檢之效益，包括實施NAT所額外檢測到的感染個案(NAT-yield case)以及降低輸血感染(transfusion-transmitted infection, TTI)風險之成效。本研究取得2013年1月15日至2023年底之捐血檢驗資料、HIV-TTI個案資訊、疑似HCV或HBV-TTI個案調查結果及歷年血液供應量等，並估計實施捐血者NAT篩檢前後的TTI風險，由於2015年以前無系統性調查HCV或HBV-TTI的機制，因此我們參考過去文獻來估計NAT實施前的HCV和HBV-TTI風險。截至2023年12月共計19,756,973捐血人次，增加NAT後額外檢測到13例HIV、86例HCV與4,585例HBV NAT-yield case，NAT-yield rate則分別為每百萬人次0.7 (95% CI: 0.4, 1.1)、4.4 (95% CI: 3.5, 5.4)及232.1 (95% CI: 225.4, 238.9)。自2013年至2023年，HCV及HBV NAT-yield rate皆呈現顯著下降的趨勢。在實施捐血者NAT篩檢前，1988-2012年間共計有21例HIV-TTI個案，實施NAT後則未再發現。截至2023年，共計有39例和5例疑似HCV及HBV-TTI的調查案件送審，但皆無確認為TTI者。TTI風險由實施NAT前的每輸注百萬單位血品發生0.24例HIV-TTI、254例HCV-TTI及100-200例HBV-TTI降至均小於千萬分之1例。台灣全面實施捐血者NAT篩檢的成效明確，大幅提升輸血安全。

Blood donor screening in Taiwan has traditionally involved serological testing to detect human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV). Universal nucleic acid testing (NAT) was implemented for blood donors on January 15, 2013. NAT substantially reduces the diagnostic window period in blood donation testing. The present study evaluated the effectiveness of NAT, focusing on detecting NAT-yield cases and reducing transfusion-transmitted infection (TTI) risks. Blood donation testing records from January 15, 2013, to December 31, 2023, data on HIV-TTI cases, data from investigations of suspected HCV or HBV-TTI cases, and historical blood component distribution data were analyzed. TTI risk was estimated for the periods before and after implementing NAT screening. Due to the absence of any systematic investigations into the risk of HCV or HBV TTI risk in Taiwan, published studies were referenced to assess preimplementation risks. As of December 2023, 13, 86, and 4585 cases of HIV, HCV, and HBV NAT-yield cases were detected, respectively, in 19,756,973 blood samples that underwent NAT, with corresponding NAT-yield rates per million of 0.7 (95% CI: 0.4, 1.1), 4.4 (95% CI: 3.5, 5.4), and 232.1 (95% CI: 225.4, 238.9), respectively. HCV and HBV NAT-yield rates significantly declined from 2013 to 2023. In total, 21 HIV TTI cases occurred before NAT screening during 1988-2012, and no cases were reported afterward. As of 2023, 39 suspected HCV-TTI cases, and 5 suspected HBV-TTI cases were submitted for review, but none were confirmed. The risks of HIV, HCV, and HBV-TTI decreased from 0.24, 254, and 100-200 per million, respectively, before NAT screening to less than 1 per 10 million after its implementation. In conclusion, universal NAT screening of blood donors effectively detects infectious diseases, substantially enhancing transfusion safety.