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在印度环境下,使用核酸检测产量/窗口期模型估算输血传播乙型肝炎、丙型肝炎和人类免疫缺陷病毒的残余风险。

Residual risk estimates of transfusion transmissible hepatitis B, hepatitis C and human immunodeficiency virus using nucleic acid testing yield/window period model in an Indian setting.

机构信息

Main Blood Bank, Department of Transfusion Medicine, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Transfus Med. 2022 Dec;32(6):492-498. doi: 10.1111/tme.12923. Epub 2022 Oct 9.

Abstract

BACKGROUND

Estimation of residual risk (RR) is necessary to understand status of blood safety with current testing strategies and need to improve it further. These estimates from India are lacking till date. Present study was aimed to estimate RR and incident rate (IR) of transfusion transmitted infectious disease (TTIDs) in Indian setting.

STUDY DESIGN AND METHODS

Blood donor demographic data, serological testing results and nucleic acid testing (NAT) screening results were collected retrospectively from January 2015 to June 2017. Mathematical modelling using NAT yield/window period model was done to estimate IR and RR of TTIDs. Data was compared between different groups based on age-group, gender, donation repeatability and type of donor.

RESULTS

A total 106 119 blood donors donated 109 441 units with overall TTID reactivity of 2.22%. HBV was most prevalent TTID (1.26%) with RR of 16.1 per million followed by HCV and HIV with RR of 4.4 and 3.1 per million donations, respectively. NAT testing variably reduced RR ranging from 69.4% to 96.1% depending on TTID. Younger, repeat and voluntary donors had significantly lower prevalence of TTIDs compared to older, first time and replacement donors.

DISCUSSION

Gaps in the blood safety could be bridged significantly by implementing NAT testing and using quality serological assays. Comparatively high RR despite using quality serological assays and ID-NAT testing highlights need to develop long term strategies to improve blood safety by focusing on improving donor pool by recruiting regular voluntary donors among youth and imparting knowledge of healthy practices.

摘要

背景

为了了解当前检测策略下血液安全状况,并进一步提高血液安全水平,有必要评估残余风险(RR)。目前,印度仍缺乏此类估计数据。本研究旨在评估印度的血液传播感染性疾病(TTIDs)RR 和发生率(IR)。

研究设计和方法

回顾性收集 2015 年 1 月至 2017 年 6 月的献血者人口统计学数据、血清学检测结果和核酸检测(NAT)筛查结果。使用 NAT 产量/窗口期模型进行数学建模,以评估 TTIDs 的 IR 和 RR。根据年龄组、性别、献血重复性和献血者类型,对不同组的数据进行比较。

结果

共有 106119 名献血者捐献了 109441 个单位,总 TTID 反应率为 2.22%。HBV 是最常见的 TTID(1.26%),RR 为每百万次 16.1 次,其次是 HCV 和 HIV,RR 分别为每百万次 4.4 次和 3.1 次。NAT 检测可降低 RR,范围从 69.4%到 96.1%,具体取决于 TTID。与老年、首次和替代献血者相比,年轻、重复和自愿献血者的 TTIDs 患病率显著降低。

讨论

通过实施 NAT 检测和使用高质量血清学检测方法,可以显著减少血液安全方面的差距。尽管使用了高质量的血清学检测方法和 ID-NAT 检测,但 RR 仍然较高,这凸显了需要制定长期战略,通过重点招募青年中的定期自愿献血者和普及健康行为知识,来改善献血者群体,从而提高血液安全性。

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