Evaluation of a lateral-flow nanoparticle fluorescence assay for TB infection diagnosis

被引：14
作者：
Stieber, F. [1 ]
Howard, J. [1 ]
Manissero, D. [2 ]
Boyle, J.
Ndunda, N.
Love, J.
Yang, M. [1 ]
Schumacher, A. [1 ]
Uchiyama, R. [1 ]
Parsons, S. [3 ]
Miller, C. [3 ]
Douwes, H. [3 ]
Mielens, Z. [3 ]
Laing, T. [3 ]
Nikolayevskyy, V [2 ,4 ]
机构：
[1] Qiagen Inc, Germantown, MD 20874 USA
[2] Qiagen Manchester Ltd, Manchester, Lancs, England
[3] Ellume Ltd, East Brisbane, Qld, Australia
[4] Imperial Coll, London, England
来源：
INTERNATIONAL JOURNAL OF TUBERCULOSIS AND LUNG DISEASE | 2021年 / 25卷 / 11期
关键词：
TB infection; QuantiFERON; QIAreach QFT; IGRA; validation; LATENT TUBERCULOSIS INFECTION; POINT;
D O I：
10.5588/ijtld.21.0391
中图分类号：
R51 [传染病];
学科分类号：
100401 ;
摘要：
BACKGROUND: 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. METHODS: In this feasibility study, we evaluated performance of a novel digital lateral-flow assay, the QIAreach (R) QuantiFERON (R) TB (QIAreach-QFT) test, against the QuantiFERON (R)-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. RESULTS: 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. CONCLUSIONS: 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.
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收藏
页码：917 / +
页数：7
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