Current status and prospects of tuberculosis diagnostic biomarkers

Abstract

At present, the tuberculosis is still severe. According to the data released by the World Health Organization (WHO) in 2018, there were about 10 million tuberculosis patients worldwide. Tuberculosis became the number one killer by single infectious diseases. There are many reasons for the current situation of tuberculosis epidemic, among which the lack of ideal early diagnosis technology is one of the important reasons. In fact, many research teams are devoting themselves to find more effective diagnostic methods for tuberculosis. Searching for suitable biomarkers for tuberculosis diagnosis is a hot research direction at present. There are more and more TB diagnostic techniques based on host or pathogen biomarkers, such as gene Xpert and IGRAs, which are widely accepted in recent years, have been used in clinic and recommended by WHO. However, the current technology is mostly in the research stage, and cannot meet the target product profiles (TPPs) proposed by WHO. So far, there are abundant biomarkers for tuberculosis diagnosis, but there are still many shortcomings, such as limited selection of biomarkers, defective queue design and lack of clinical validation data. This article hopes to summarize the existing tuberculosis diagnostic biomarkers and provide some clues for the development of tuberculosis diagnostic technology.

Abstract

摘要： 目前结核病疫情仍然不容乐观, 根据世界卫生组织(WHO) 2018发布的数据显示, 全球结核病患者约1 000 万, 是高于艾滋病在内的单一传染病中的头号杀手。造成结核病流行的现状有多个方面的原因, 其中缺乏理想的早期 诊断技术是其中一个重要原因。因此, 国内外许多研究团队都在致力于研发更加有效的结核病诊断手段和方法。寻 找适用于结核病诊断的生物标志物是目前研究的热门。基于宿主或病原体的生物标志物的结核病诊断技术越来越 多, 例如近年来广泛被接受的gene Xpert、IGRAs检测技术已经用于临床并且被WHO推荐。然而目前的技术大多处于 研究阶段, 并不能满足WHO 提出的结核病诊断目标产品特性(target product profiles, TPPs)。迄今为止, 用于结核病诊断 生物标志物非常丰富, 但是还有许多缺陷, 如标志物的有限选择、队列设计的缺陷和缺乏临床验证数据。本文希望对 现有的结核病诊断生物标志物进行归纳总结, 为结核病诊断技术的研发提供线索。