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核酸扩增检测(NAT)能否替代血清学检测?一项前瞻性研究,来自土耳其红新月会的18200名献血者的检测结果。

Can the nucleic acid amplification test (NAT) be an alternative to the serologic tests? A prospective study, the results of 18,200 blood donors from the Turkish Red Crescent.

作者信息

Kosan Erdogan, Kocazeybek Bekir, Altunay Hüsnü, Aymelek Meryem, Alan Esra, Saribas Suat, Aslan Mustafa, Yenen Osman Sadi, Yuksel Pelin, Birinci Ilhan, Kirali Kaan, Aksoy Armagan

机构信息

Capa, Red Crescent Blood Center, İstanbul, Turkey.

Istanbul University, Cerrahpaşa Faculty of Medicine, Microbiology and Clinical Microbiology Department, İstanbul, Turkey.

出版信息

Transfus Apher Sci. 2010 Dec;43(3):269-272. doi: 10.1016/j.transci.2010.09.013. Epub 2010 Oct 12.

DOI:10.1016/j.transci.2010.09.013
PMID:20943441
Abstract

AIM

Serologic tests having high sensitivity and specificity are used in order to prevent contamination with infectious agents from blood and blood products for transfusion safety. The present serologic tests have problems such as low sensitivity and weak detection capacity of infectious agents in the "window period". We aimed to test the use of NAT (Nucleic Acid Amplification Test) in routine blood screening in the Blood Bank.

METHOD

We used the Procleix Ultrio (Chiron Ltd., USA) test kit based TMA (Transcription Mediated Amplification) for the NAT study of serum samples from 18,200 donors who came to the Turkish Red Crescent between February 2007 and September 2008. The NAT positive samples were studied twice. The discrimination of HIV, HCV and HBV NAT positive samples was performed by the Procleix Discrimination (Chiron Ltd., USA) test. Otherwise, Micro ELISA were used in parallel for routine serological screening of Anti-HIV, Anti-HCV, and HBsAg with Vironoste HIV Uni-form, AG/Ab innotest HCV Ab and Hepanostika Ultra HBsAg test kits.

RESULTS

The results of serum samples with serology (+) and NAT (+) (13/18,200 and 0.05%) for anti-HIV, anti-HCV and HBsAg were higher than in other NAT studies; we also detected that a transfusion risk can occur in every 1400 transfusions.

摘要

目的

为确保输血安全,使用具有高灵敏度和特异性的血清学检测方法来防止血液及血液制品受到感染性病原体的污染。目前的血清学检测存在诸如灵敏度低以及在“窗口期”对感染性病原体检测能力弱等问题。我们旨在检测核酸扩增检测(NAT)在血库常规血液筛查中的应用。

方法

我们使用基于转录介导扩增(TMA)的Procleix Ultrio(美国凯龙公司)检测试剂盒,对2007年2月至2008年9月期间到土耳其红新月会的18200名献血者的血清样本进行NAT研究。对NAT阳性样本进行了两次检测。HIV、HCV和HBV NAT阳性样本的鉴别通过Procleix鉴别(美国凯龙公司)检测进行。否则,使用Vironoste HIV Uni-form、AG/Ab innotest HCV Ab和Hepanostika Ultra HBsAg检测试剂盒并行进行抗HIV、抗HCV和HBsAg的常规血清学筛查。

结果

抗HIV、抗HCV和HBsAg血清学(+)和NAT(+)(13/18200,0.05%)的血清样本结果高于其他NAT研究;我们还检测到每1400次输血中可能会出现一次输血风险。

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