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一个新的缓解策略,用于预防输血传播的疟疾

Laura Tonnetti¹, Jamel A Groves¹, Deanna Self²

¹Scientific Affairs, American Red Cross, Rockville and Gaithersburg, Maryland, USA.

|November 29, 2023

概括

一种新的核酸测试可以准确地检测献血者的疟疾,显示出高灵敏度和特异性. 这种Plasmodium检测可以改善捐赠者查,并减少对疟疾风险的不必要推迟.

科学领域:

医学诊断医学诊断医学诊断
传染病研究传染病研究.
输血安全输血安全

背景情况:

疟疾是一个重要的全球健康问题,由杆菌寄生虫引起,由Anopheles蚊子传播.
目前美国的献血者查依赖于问卷来评估疟疾风险,导致基于旅行或病史的推迟.
现有的方法可能无法有效识别所有有风险的捐赠者,或可能不必要地推迟符合条件的个人.

研究的目的:

评估Procleix Plasmodium Assay的性能,这是一个用于疟疾检测的新型核酸测试.
为了确定测试的灵敏度和特异性在选献血.
评估本试验在改善献血者疟疾风险评估方面的潜力.

主要方法:

普罗克莱克斯的等离子体检测利用转录介导放大 (TMA) 来检测等离子体18S核糖体RNA.
使用体外成绩单和感染红细胞来评估分析灵敏度.
临床特异性通过查12,800个个人捐赠和283个来自美国捐赠者的综合样本来评估,其中包括862名因疟疾风险而被推迟的捐赠者.

主要成果:

该试验显示出高分析灵敏度,检测到只有8.47-11.89RNA拷贝/毫升和2.10-6.82感染红细胞/毫升.
临床特异性很好,个体捐献为99.99%,聚合样本为100%.
一位因疟疾风险而被推迟的捐赠者 (0.12%) 呈阳性,证实了该测试在无症状个体中检测菌的能力.

结论:

普罗克莱克斯的Plasmodium Assay具有很高的灵敏度和特异性,用于在献血中检测Plasmodium RNA.
该试验成功地在无症状的捐赠者中发现了等离子体,突出显示了其早期检测的潜力.
这种核酸测试为传统的基于风险的查问题提供了有希望的替代方案或补充,有可能提高血液供应安全性并减少捐赠者推迟.

关键词:

输血传播的疟疾是输血传播的疟疾.

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