核酸擴增試驗應用於捐血者病毒檢驗之成本效益分析

Analysis of cost saving from nucleic acid amplification testing of all blood donations for viral infection in Taiwan

目標：台灣於2013年全面施行捐血者核酸放大試驗（Nucleic acid Amplification Test, NAT）來篩檢愛滋病毒（HIV），C型肝炎病毒（HCV）及B型肝炎病毒（HBV）。本研究以NAT 實施四年所避免之輸血感染數來評估常規免疫酵素法加測NAT之後，相對於只用免疫酵素法檢測可節約之成本。方法：我們以免疫酵素法檢驗血清標記陰性而NAT檢驗陽性（NAT yield case）個案數、可製成血品數、輸血族群未曾感染比例及病毒傳染力來估計可避免輸血感染數（transfusion-transmitted infection, TTI）。雖然捐血加測NAT增加血液供應成本，但加測NAT可節省支出包含TTI之醫療照護成本、道義救濟成本、訴訟成本及HIV帶原捐血者二次傳播醫療成本。我們比較兩者之間的差異來進行成本效益分析。結果：2013-2016年共檢測7,001,347人次，NAT yield case為HIV 6人，HCV 52人及HBV 1,927人。NAT檢驗及人事成本共738,534,700元。TTI估計值為HIV 16.7例、HCV 115.6例、HBV 55.2例，以及HBV潛隱性個案持續捐血至65歲造成TTI 1,032.2例，合計可避免之TTIs共1,219.7例。可節省之醫療照護成本259,075,635元，道義救濟金642,000,000元，法律訴訟97,800,000元，捐血者二次傳播醫療成本28,448,352元，合計1,027,323,987元。結論：2013-2016台灣捐供血系統全面加測NAT實際檢驗支出7.4億元，預估可避免約1,220例TTIs，預估可節省支出10.3億元。以輸血感染事件而言，自全面篩檢至今（2018年3月）未曾發生HIV TTI，篩檢成效明確。（台灣衛誌2018；37（5）：527-538）。 Nucleic acid amplification testing (NAT) of all blood donations for human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) has been performed in Taiwan since 2013. We analyzed the benefits of universal NAT by estimating the number of prevented transfusion-transmitted infections (TTIs) and calculating the saved cost of medical expenditures, relief payments, litigation costs, and medical care for secondary HIV transmission. Methods: We determined the number of NAT yield cases (seronegative NAT-reactive donors) during the study period of 2013–2016. The number of prevented TTIs was estimated based on the number of NAT yield cases after considering the number of blood components produced per donation, recipient susceptibility, and viral infectivity. Results: Among 7,001,347 donations, we identified 6 HIV, 52 HCV, and 1927 HBV seronegative NAT-reactive donors. The expected number of prevented TTIs was 16.7 for HIV, 115.6 for HCV, and 55.2 for HBV. After further considering donations contributed from donors with occult HBV infection, an additional 1032.2 cases of TTIs were prevented. An estimated 1219.7 cases of TTIs were prevented. The cost of NAT during the 4 years was NT$740 million. The estimated savings from medical expenditures, relief payments, litigation costs, and secondary transmissions of HIV from NAT yield cases were respectively NT$259 million; NT$642 million; NT$98 million; and NT$28 million. The savings attributed to NAT screening totaled NT$1,027 million. Conclusions: Universal NAT improves the safety of blood donation. The total cost of NAT in Taiwan was NT$740 million over 4 years. An estimated 1,220 TTIs were prevented, and approximately NT$1,027 million was saved. NAT screening of donor blood is conclusively cost effective. (Taiwan J Public Health. 2018;37(5):527-538).