Safic Stanic Hana, Babic Ivana, Maslovic Margareta, Dogic Vesna, Bingulac-Popovic Jasna, Miletic Manuela, Jurakovic-Loncar Nina, Vuk Tomislav, Strauss-Patko Maja, Jukic Irena
Croatian Institute of Transfusion Medicine (CITM), Zagreb, Croatia.
Josip Juraj Strossmayer University of Osijek, Osijek, Croatia.
Transfus Med Hemother. 2017 Nov;44(6):415-420. doi: 10.1159/000457965. Epub 2017 May 5.
Croatia implemented individual donation (ID)-NAT testing of blood donors in 2013 for three viruses HBV, HCV, and HIV-1 as a mandatory test for all blood donors. This study assessed the impact of NAT screening 3 years after its implementation.
A total of 545,463 donations were collected and screened for HBV, HCV, and HIV-1 using the Procleix Ultrio Plus Assay. All initially reactive (IR) NAT samples were retested in triplicate and, if repeatedly reactive (RR), NAT discriminatory assay (dNAT) was performed. ID-NAT positive donations were confirmed by RT-PCR on the COBAS AmpliPrep/TaqMan platform.
Out of 545,463 samples tested, 108 (0.02%) were RR in NAT. There were 82 (75,9%) HBV reactive, 16 (14.8%) HCV reactive, and 10 (9.3%) HIV-1 reactive samples. 51 (47.2%) samples were ID-NAT positive only. Out of these 51 NAT yield cases, 1 window period HIV-1 and 50 occult HBV infections (OBI) were determined. There were only two potential HBV DNA transmissions from OBI donors.
The implementation of NAT screening for three viruses has improved blood safety in Croatia. During the 3-year period, 1 window period HIV-1 and a number of occult HBV donations were identified.
克罗地亚于2013年对献血者实施了针对三种病毒(乙肝病毒、丙肝病毒和人类免疫缺陷病毒1型)的个体捐赠核酸检测(ID-NAT),作为所有献血者的强制检测项目。本研究评估了核酸检测实施3年后的影响。
共采集了545,463份血液样本,使用Procleix Ultrio Plus检测法对乙肝病毒、丙肝病毒和人类免疫缺陷病毒1型进行检测。所有最初反应性(IR)核酸检测样本均进行一式三份的复测,若反复反应性(RR),则进行核酸鉴别检测(dNAT)。ID-NAT阳性的血液样本通过在COBAS AmpliPrep/TaqMan平台上进行逆转录聚合酶链反应(RT-PCR)来确认。
在检测的545,463份样本中,有108份(0.02%)在核酸检测中呈反复反应性。其中82份(75.9%)对乙肝病毒反应性,16份(14.8%)对丙肝病毒反应性,10份(9.3%)对人类免疫缺陷病毒1型反应性。51份(47.2%)样本仅ID-NAT呈阳性。在这51例核酸检测阳性病例中,确定了1例窗口期人类免疫缺陷病毒1型感染和50例隐匿性乙肝病毒感染(OBI)。仅有两例潜在的由OBI献血者传播乙肝病毒DNA的情况。
对三种病毒实施核酸检测提高了克罗地亚的血液安全性。在这3年期间,发现了1例窗口期人类免疫缺陷病毒1型感染和一些隐匿性乙肝病毒感染的献血情况。