Qiagen Inc, Germantown, MD, USA.
Qiagen Manchester Ltd, Manchester, UK.
Int J Tuberc Lung Dis. 2021 Nov 1;25(11):917-922. doi: 10.5588/ijtld.21.0391.
Programmatic management of TB infection is a critical component of the WHO End TB Strategy. Interferon-gamma release assays (IGRAs) overcome some limitations of the tuberculin skin test, but implementation of IGRA testing in low-resource settings is challenging. In this feasibility study, we evaluated performance of a novel digital lateral-flow assay, the QIAreach QuantiFERON TB (QIAreach-QFT) test, against the QuantiFERON-TB Gold Plus (QFT-Plus) assay. A population with a mix of risk factors for TB infection (111 donors) were sampled over multiple days. A total of 207 individual blood samples were tested according to the manufacturer´s instructions. The overall percentage agreement was 95.6% (two-sided 95% CI 91.8-98), with a positive percentage agreement (i.e., sensitivity) of 100% (95% CI 94.7-100) and a negative percentage agreement (i.e., specificity) of 95.6% (95% CI 90.6-98.4). All QFT-Plus positive specimens with TB1-Nil and TB2-Nil values less than 1 IU/ml tested positive on QIAreach-QFT. QIAreach QFT is a deployable, accurate testing solution for decentralised testing. It has the potential to overcome key hurdles for TB infection screening in high-burden settings thus helping to achieve the WHO End TB programme goals.
方案式结核病感染管理是世界卫生组织终止结核病策略的一个重要组成部分。干扰素-γ释放检测（IGRAs）克服了结核菌素皮肤试验的一些局限性，但在资源匮乏环境中实施 IGRA 检测具有挑战性。在这项可行性研究中，我们评估了一种新型数字侧向流动检测（QIAreach QuantiFERON TB，QIAreach-QFT）与 QuantiFERON-TB Gold Plus（QFT-Plus）检测相比的性能。研究人群具有结核病感染的多种危险因素（111 名供体），并在多日时间内进行采样。按照制造商的说明共检测了 207 份个体血样。总体百分比一致性为 95.6%（双侧 95%CI 91.8-98），阳性百分比一致性（即敏感性）为 100%（95%CI 94.7-100），阴性百分比一致性（即特异性）为 95.6%（95%CI 90.6-98.4）。TB1-Nil 和 TB2-Nil 值均小于 1IU/ml 的所有 QFT-Plus 阳性标本在 QIAreach-QFT 上均呈阳性。QIAreach-QFT 是一种可部署的、准确的检测解决方案，适用于分散式检测。它有可能克服高负担环境中结核病感染筛查的关键障碍，从而有助于实现世界卫生组织终止结核病规划目标。
