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在资源有限环境下采用核酸扩增技术进行献血者筛查的意义:来自印度南部一个单一中心的研究

Significance of Adopting Nucleic Acid Amplification Technique for Blood Donor Screening in a Resource Limited Setting: A Study from a Single Centre in South India.

作者信息

Ranganathan Sudha, Iyer Ranganathan N, Balakrishna Nagalla

机构信息

Department of Blood Transfusion Medicine, Apollo Hospitals and Health City, Jubilee hills, Hyderabad, Telangana 500096 India.

Department of Clinical Microbiology, ID and Infection Control, Gleneagles Global Hospital, Hyderabad, Telangana India.

出版信息

Indian J Hematol Blood Transfus. 2022 Jul;38(3):571-576. doi: 10.1007/s12288-021-01500-2. Epub 2021 Oct 27.

Abstract

Nucleic acid Amplification testing (NAT) has helped improve blood safety and detect window period and Occult Hepatitis B infections (OBI) This study was aimed at determining the following in blood donors: 1. seroprevalence of HIV, HBV & HCV, malarial parasite and Syphlis 2. NAT and seroyield for HIV, HBV and HCV 3. viral load in NAT yield donations 4. Pattern of HBV serological markers in HBV NAT yield donations 80,809 blood donations were screened over an 8 year period (2012-2019) for antiHIV I and II, HBsAg, antiHCV antibodies, malarial parasite and VDRL. Seronegative samples were tested by NAT using a multiplex PCR in a pool of six. NAT yield samples were tested for viral load and HBV serological markers. Seropositive samples were tested for NAT and checked for seroyield. SPSS windows version 24.0 was used for statistical analysis. 1.07% of blood donors were found to be seropositive with 0.08%, 0.86%, 0.09%, 0.03% and 0 for anti HIV I and II, HBsAg, antiHCV, VDRL and Malarial parasite respectively. Out of 79,938 seronegative samples, 20 samples (0.025%) were NAT positive for Hepatitis B with a NAT yield OF 1:3997. Out of the 20 NAT positive samples, 17 were OBI and three were window period infections. 14 NAT yield samples subjected to a HBV viral load assay showed a range of < 6-146 IU/ml. Minipool NAT in pools of six is able to indentify both OBI and window period infections. NAT could significantly improve the blood safety in a resource limited setting like India.

摘要

核酸扩增检测(NAT)有助于提高血液安全性,并检测窗口期和隐匿性乙型肝炎感染(OBI)。本研究旨在确定献血者中的以下情况:1. 人类免疫缺陷病毒(HIV)、乙型肝炎病毒(HBV)、丙型肝炎病毒(HCV)、疟原虫和梅毒的血清流行率;2. HIV、HBV和HCV的NAT及血清检出率;3. NAT检出的献血中的病毒载量;4. HBV NAT检出的献血中HBV血清学标志物的模式。在8年期间(2012 - 2019年),对80809份献血进行了抗HIV I和II、乙肝表面抗原(HBsAg)、抗HCV抗体、疟原虫和性病研究实验室玻片试验(VDRL)的筛查。血清学阴性样本采用多重聚合酶链反应(PCR)在6份样本的混合池中进行NAT检测。对NAT检出的样本进行病毒载量和HBV血清学标志物检测。血清学阳性样本进行NAT检测并检查血清检出率。使用社会科学统计软件包(SPSS)Windows版24.0进行统计分析。发现1.07%的献血者血清学呈阳性,其中抗HIV I和II、HBsAg、抗HCV、VDRL和疟原虫的阳性率分别为0.08%、0.86%、0.09%、0.03%和0。在79938份血清学阴性样本中,20份样本(0.025%)的乙型肝炎NAT呈阳性,NAT检出率为1:3997。在这20份NAT阳性样本中,17份为OBI,3份为窗口期感染。对14份NAT检出的样本进行HBV病毒载量检测,结果显示范围为<6 - 146国际单位/毫升。6份样本混合的微量池NAT能够识别OBI和窗口期感染。在印度这样资源有限的环境中,NAT可以显著提高血液安全性。

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