Human Assisted Reproduction Ireland, Rotunda Hospital, Dublin 1, Dublin.
Hum Reprod. 2011 Nov;26(11):3169-72. doi: 10.1093/humrep/der278. Epub 2011 Aug 23.
The frequency for virology testing for couples undergoing assisted reproductive treatment (ART) in Europe is currently under debate, with little scientific data available to support the time-frame imposed by EU legislation. The aim of this study was to determine the incidence of blood-borne viruses (BBV) in this population and to assess the likelihood of seroconversion after an initial negative screen and the possible cost saving to couples.
We identified all cases where a BBV screen was performed on patients attending our tertiary referral unit for ART. We calculated the incidence of Hepatitis B surface antigen, Hepatitis C antibody and HIV infection in this population and the incidence of seroconversion in follow-up screening (which included Hepatitis B core antibody) following the implementation of the EU legislation. In all cases identified, we sought to assess the risk of seroconversion after an initial negative screen.
Between 1998 and 2009, we identified a total of 79 291 tests performed in over 12 500 patients. The incidence in this population of Hepatitis B surface antigen was 0.28% (37/12,797), Hepatitis B core antibody 3.32% (96/2891), Hepatitis C antibody 0.33% (43/12,762) and HIV 0.007% (1/12,819). We were able to show that for over 6500 individuals who were tested and re-tested for all three viruses, no seroconversions were reported.
Based on the above measured negligible risk of seroconversion after an initial negative screen in co-habitating couples participating in an ART programme, current legislation requiring screening of couples at each procurement of cells in the assisted reproductive setting is not clinically justified.
目前,欧洲对接受辅助生殖治疗(ART)的夫妇进行病毒学检测的频率存在争议,因为支持欧盟立法规定的时间框架的科学数据很少。本研究的目的是确定该人群中血液传播病毒(BBV)的发生率,并评估初次阴性筛查后的血清转化可能性以及对夫妇可能的节省成本。
我们确定了在我们的三级转诊单位接受 ART 的患者中进行 BBV 筛查的所有病例。我们计算了该人群中乙型肝炎表面抗原、丙型肝炎抗体和 HIV 感染的发生率,以及在欧盟立法实施后(包括乙型肝炎核心抗体)的后续筛查中血清转化的发生率。在所有确定的病例中,我们试图评估初次阴性筛查后的血清转化风险。
1998 年至 2009 年,我们共发现 12500 名患者中的 79291 例检测结果。该人群中乙型肝炎表面抗原的发生率为 0.28%(37/12797),乙型肝炎核心抗体为 3.32%(96/2891),丙型肝炎抗体为 0.33%(43/12762),HIV 为 0.007%(1/12819)。我们能够证明,对于超过 6500 名接受过所有三种病毒检测和重新检测的个体,没有报告血清转化。
根据最初阴性筛查后在共同生活的夫妇中进行 ART 计划时,血清转化的风险极低,目前要求在辅助生殖环境中每次获取细胞时对夫妇进行筛查的立法在临床上是没有理由的。