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. 2021 Nov 1;25(11):917-922.
doi: 10.5588/ijtld.21.0391.

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

F Stieber  1 , J Howard  1 , D Manissero  2 , J Boyle  3 , N Ndunda  3 , J Love  3 , M Yang  1 , A Schumacher  1 , R Uchiyama  1 , S Parsons  4 , C Miller  4 , H Douwes  4 , Z Mielens  4 , T Laing  4 , V Nikolayevskyy  5
Affiliations

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

F Stieber et al. Int J Tuberc Lung Dis. .

Abstract
in English, French

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® 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.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.

CONTEXTE:: La prise en charge programmatique de l’infection tuberculeuse est une composante essentielle de la stratégie de l’OMS pour mettre fin à la TB. Les tests de détection de l’interféron gamma (IGRA) pallient certaines limites du test d’intradermoréaction à la tuberculine, mais l’utilisation des tests IGRA en cas de faibles ressources est difficile.

MÉTHODES:: Dans cette étude de faisabilité, nous avons évalué les performances d’une nouvelle test numérique de flux latéral (QIAreach® QuantiFERON® TB [QIAreach-QFT]) par rapport au test QuantiFERON®-TB Gold Plus (QFT-Plus). Des prélèvements ont été effectués sur plusieurs jours chez une population ayant divers facteurs de risque d’infection tuberculeuse (111 donneurs). Au total, 207 échantillons sanguins individuels ont été testés conformément aux instructions du fabricant.

RÉSULTATS:: Le pourcentage de concordance globale était de 95,6% (IC 95% bilatéral 91,8–98), avec un pourcentage de concordance positive (c.-à-d., sensibilité) de 100% (IC 95% 94,7–100) et un pourcentage de concordance négative (c.-à-d., spécificité) de 95,6% (IC 95% 90,6–98,4). Tous les échantillons positifs par QFT-Plus avec des valeurs TB1-Nil et TB2-Nil inférieures à 1 UI/ml ont été testés positifs par QIAreach-QFT.

CONCLUSIONS:: QIAreach QFT est un test fiable, à même d’être déployé afin de décentraliser le processus de dépistage. Il peut pallier les principaux inconvénients du dépistage de l’infection tuberculeuse dans les pays à forte incidence, et peut ainsi contribuer à atteindre les objectifs de la stratégie de l’OMS pour mettre fin à la TB.

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Figures

Figure 1
Figure 1
QIAreach QFT digital detection cartridge (eStick). Exploded QIAreach QFT eStick. Casing (blue) contains lateral flow assay strip with optoelectronic technology and a microprocessor that converts a fluorescent signal into a qualitative readout for the detection of interferon-gamma in the plasma sample that has been stimulated by peptide antigens that are associated with M. tuberculosis.
Figure 2
Figure 2
Performance of QFT-Plus antigen blood collection tubes vs. QIAreach QFT. IFN-γ = interferon-gamma.
Figure 3
Figure 3
QIAreach QFT-positive time to result correlation with QFT-Plus (IU/mL). IFN-γ =interferon-gamma; QFT=QuantiFERON.
Figure 4
Figure 4
QIAreach assay workflow. The QIAreach QFT workflow is fast, simple and easy and has four steps: 1) collect blood into a single QIAreach QFT BCT; 2) incubate BCT to stimulate an in vitro TB immune response; 3) perform the QIAreach QFT digital detection assay using a disposable cartridge (eStick) powered by a multi-port reader (eHub); 4) read result on eHub display in 3–20 minutes. BCT = blood collection tube.
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