Evaluation of a lateral-flow nanoparticle fluorescence assay for …: Ingenta Connect

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.
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.
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.
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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QIAreach QFT;
TB infection;

Document Type: Research Article

Qiagen Inc, Germantown, MD, USA
Qiagen Manchester Ltd, Manchester, UK
Former Qiagen employee
Ellume Limited, East Brisbane, QLD, Australia
Qiagen Manchester Ltd, Manchester, UK, Imperial College, London, UK

Publication date:
01 November 2021

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  • The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as COVID-19, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details.

    The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication. Read fast-track articles.

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