NAT 시행 이후 C형 간염바이러스 수혈감염위험도의 변화 = Residual Risk of Transfusion-Transmitted Infection with Hepatitis C Virus since the Introduction of Nucleic Acid Testing in Korea

다국어 초록 (Multilingual Abstract)

Background: In 2005, the Korean Red cross introduced mini-pool nucleic acid testing (NAT) for human immunodeficiency virus (HIV) and hepatitis C virus (HCV), which upgraded to individual donation (ID) NAT including HBV in 2012. In this study, we analyzed the trend of HCV infection among blood donors after introduction of NAT by estimating the residual risk (RR) of transfusion transmitted infection (TTI) of HCV.
Methods: Donation data from 2003 to 2014 were analyzed using the Blood Information Management System (BIMS). Each donation was tested for antibodies and viral RNA for HCV. Prevalence and incidence rate (IR) among repeat donors were determined. RR was determined using the incidence rate/window period model.
Results: During the 12-year period, a total of 29,058,436 donations were screened with 34 HCV NAT yield donations. Calculated RR per million donations for HCV was significantly reduced from 13.41 in the pre-NAT period (2003∼2004) to 0.52 in the post NAT period (2006∼2007) (P＜0.001). Most recently (2013∼2014), RR for HCV with TTI was estimated by 0.16 per million donations (1:6,289,308).
Conclusion: RR of TTI with HCV was remarkably decreased since introduction of NAT. However, the prevalence and IR of HCV RNA among first time donors was still high and yield cases were more frequent among repeat donors. Therefore, establishment of a sensitive and accurate screening system and measures for maintaining healthy donors should be considered in order to ensure blood safety.

국문 초록 (Abstract)

배경: 2005년 대한적십자사에서는 HIV, HCV 에 대한 혼주핵산증폭검사(mini-pool nucleic acid testing, NAT)를 도입하였으며, 2012년에는 HBV 가 포함한 개별검사 NAT 시스템으로 대체되었다. 본 연구에서는 NAT 도입 이후의 HCV에 대한수혈감염 잔존위험도를 측정함으로써 헌혈자에서의 HCV 감염의 추이를 분석하였다.
방법: 혈액정보관리시스템을 이용하여 2003년부터 2014년까지의 헌혈 혈액의 데이터를 분석하였다. 각각의 헌혈 혈액에 대하여는 HCV항체검사와 HCV RNA 검사가 실시되었다. 초회 및 다회헌혈자군의 유병률과 발생률을 산출하였고, HCV에 대한 수혈감염 잔존위험도(residual risk, RR)를 incidence rate/window period model로 산출하였다.
결과: 12년 동안 총 29,058,436건의 헌혈 혈액에 대한 검사가 실시되어 34건의 NAT yield가 발생하였다. HCV에 대한 잔존위험도는 NAT 도입전(2003∼2004)인 13.41/106 donations에서 NAT 도입 후(2006∼2012) 0.52/106 donations로 급격히감소하였으며(P＜0.001), 가장 최근의(2013∼2014) HCV 수혈 감염 잔존위험도는 100만명 당 0.16으로 계산되었다(1:6,289,308).
결론: NAT 도입 이후 HCV에 대한 수혈감염잔존위험도는 현저하게 감소하였다. 그러나 초회헌혈자군에서의 유병률은 여전히 높고, 다회헌혈자군에서는 yield 사례가 여전히 빈번하게 나타났다. 따라서 혈액의 안전성 보증을 위해 민감하고정확한 선별검사방법의 확립과 건강한 헌혈자를확보하기 위한 수단이 고려되어야 한다고 사료된다.

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