Koch Carmo, Araújo Fernando
Serviço de Imuno-hemoterapia. Centro Hospitalar S. João. Porto. Portugal..
Acta Med Port. 2013 Jul-Aug;26(4):371-6. Epub 2013 Aug 30.
INTRODUCTION/OBJECTIVES: Monitoring the residual risk of transfusion-transmitted viral infections is important to evaluate the improvement achieved in the blood donation safety and to adopt policies to reduce risks. The present study calculates the incidence of the key infectious diseases, human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) as well as the residual risk of transfusion-transmitted viral infections, during twelve years, 1999 through 2010. Data were analyzed over 3 periods of 4 years (1999-2002, 2003-2006 and 2007-2010). The risk estimates were compared to those previously obtained for blood donations occurred between 1991 and 1998.
The study included 209 640 blood donations, from 42 634 regular, volunteers and unpaid donors. The residual risk of transfusion-transmitted infection per million donations was calculated, for each virus, through mathematical model "Incidence rate/window period", described by Schreiber et al. All donations were screened according to Portuguese legislation. In January 2001, the nucleic acid testing in minipool was implemented on all blood donations, for screening simultaneously HIV-1 and HCV ribonucleic acid (RNA) (Cobas Amplicor Ampliscreen-Roche©). This test was replaced, in January 2007, by the simultaneous screening of HBV deoxyribonucleic acid, HCV RNA and HIV-1/HIV-2 RNA, in minipool (Cobas Taqscreen MPX Test-Roche©).
The residual risk of transmitting viral infections during the transfusion of blood components is very small and has declined over the years. After the implementation of the nucleic acid testing in minipool for the three viruses, the risk of giving blood during an infectious window period was estimated as follows: for human immunodeficiency virus, 1 in 1.67 million, for hepatitis C virus 1 in 3.33 million and for hepatitis B virus 1 in 526 000.
During the 12 years under study, we found a decrease in residual risk for the three viruses, by a factor around five for human immunodeficiency virus and hepatitis B virus, and 32 for hepatitis C virus. If we compare the estimates previously calculated for 1991-1998 period to 2007-2010 period (over 20 years), the decrease is still more relevant with a residual risk of human immunodeficiency virus, hepatitis B virus and hepatitis C virus respectively 19-fold, 6-fold and 54-fold lower.
引言/目的：监测输血传播病毒感染的残余风险对于评估献血安全性的改善以及采取降低风险的政策至关重要。本研究计算了1999年至2010年这十二年期间主要传染病——人类免疫缺陷病毒（HIV）、乙型肝炎病毒（HBV）和丙型肝炎病毒（HCV）的发病率以及输血传播病毒感染的残余风险。数据在三个四年期（1999 - 2002年、2003 - 2006年和2007 - 2010年）进行分析。将风险估计值与之前获得的1991年至1998年期间献血的风险估计值进行比较。
该研究纳入了来自42634名定期、自愿且无偿献血者的209640份献血样本。通过施赖伯等人描述的数学模型“发病率/窗口期”计算每种病毒每百万次献血中输血传播感染的残余风险。所有献血样本均按照葡萄牙法律进行筛查。2001年1月，对所有献血样本实施混合样本核酸检测，以同时筛查HIV - 1和HCV核糖核酸（RNA）（Cobas Amplicor Ampliscreen - Roche©）。2007年1月，该检测被混合样本中同时筛查HBV脱氧核糖核酸、HCV RNA和HIV - 1/HIV - 2 RNA（Cobas Taqscreen MPX Test - Roche©）所取代。
血液成分输血期间传播病毒感染的残余风险非常小，且多年来一直在下降。在对三种病毒实施混合样本核酸检测后，感染窗口期献血的风险估计如下：对于人类免疫缺陷病毒，为1/167万；对于丙型肝炎病毒，为1/333万；对于乙型肝炎病毒，为1/52.6万。
在本研究的12年期间，我们发现三种病毒的残余风险有所下降，人类免疫缺陷病毒和乙型肝炎病毒下降了约五倍，丙型肝炎病毒下降了32倍。如果将之前计算的1991 - 1998年期间与2007 - 2010年期间（超过20年）的估计值进行比较，下降幅度更为显著，人类免疫缺陷病毒、乙型肝炎病毒和丙型肝炎病毒的残余风险分别降低了19倍、6倍和54倍。
