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

• DOI: 10.5588/ijtld.21.0391
• Publication Date: 2021-10-23T04:38:56Z
• Authors: F. Stieber; J. Howard; D. Manissero; J. Boyle; N. Ndunda; J. Love; M. Yang; A. Schumacher; R. Uchiyama; S. Parsons; C. Miller; H. Douwes; Z. Mielens; T. Laing; V. Nikolayevskyy
• Keywords: QuantiFERON; Interferon γ; Tuberculosis diagnosis; Gold standard (test)

BACKGROUND: Programmatic management of TB infection is a critical component the WHO End Strategy. Interferon-gamma release assays (IGRAs) overcome some limitations tuberculin skin test, but implementation IGRA testing in low-resource settings challenging.METHODS: In this feasibility study, we evaluated performance novel digital lateral-flow assay, QIAreach® QuantiFERON® (QIAreach-QFT) against QuantiFERON®-TB Gold Plus (QFT-Plus) assay. A population with mix risk factors for (111 donors) were sampled over multiple days. total 207 individual blood samples tested according to manufacturer´s instructions.RESULTS: The overall percentage agreement was 95.6% (two-sided 95% CI 91.8-98), positive (i.e., sensitivity) 100% (95% 94.7-100) and negative specificity) 90.6-98.4). All QFT-Plus specimens TB1-Nil TB2-Nil values less than 1 IU/ml on QIAreach-QFT.CONCLUSIONS: QIAreach QFT deployable, accurate solution decentralised testing. It has potential key hurdles screening high-burden thus helping achieve programme goals.