QIAreach QuantiFERON-TB for the diagnosis of<i>Mycobacterium tuberculosis</i>infection

Saluzzo, Francesca; Mantegani, Paola; Chaurand, Valeria Poletti de; Cirillo, Daniela María

doi:10.1183/13993003.02563-2021

Cited by 16 publications

(14 citation statements)

References 12 publications

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“…This study represents the first performance evaluation performed in an intermediate TB burden setting. The study results demonstrated an excellent level of agreement as well as high sensitivity and specificity of QIAreach QFT compared to QFT-Plus when implemented in routine settings in Malaysia, confirming previous results achieved in Milan, Japan and USA [29,31,33]: OPA, PPA (sensitivity) and NPA (specificity) exceeding 94% [36].…”

Section: Discussionsupporting

confidence: 84%

“…QIAreach QFT leverage the same technology as the TB2 tube of QFT-Plus, is portable, simple to perform and requires only 1 ml of blood from each patient [14,29,[31][32][33].…”

Section: Introductionmentioning

confidence: 99%

“…So far three studies have compared the new QIAreach QFT test against the established (FDA[Food and Drug Administration]-approved and CE [European Community]-marked) QuantiFERON 1 -TB Gold Plus test in detecting TB infection, both conducted in low incidence settings (Milan, Japan and USA, respectively) [29,31,33].…”

Section: Introductionmentioning

confidence: 99%

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First evaluation of the performance of portable IGRA, QIAreach® QuantiFERON®-TB in intermediate TB incidence setting

et al. 2023

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Diagnosis and treatment of tuberculosis infection (TBI) are the core elements of tuberculosis elimination. Interferon gamma release assays have advantages over the tuberculin skin test, although their implementation in low-resource settings is challenging. The performance of a novel digital lateral flow assay QIAreach® QuantiFERON®-TB (QIAreach QFT) against the QuantiFERON®-TB Gold Plus (QFT-Plus) assay was evaluated in an intermediate incidence setting (Malaysia) according to the manufacturer’s instructions. Individuals aged 4–82 years, who were candidates for TB infection screening for contact investigation were prospectively recruited. On 196 samples, the QIAreach-QFT showed a positive percent agreement (sensitivity) was 96.5% (CI 87.9–99.6%), a negative percent agreement (specificity) 94.2% (CI 88.4% to 97.6%) and an overall percentage of agreement was 94.9% (95% CI 90.6–97.6%) with a Cohen’s κ of 0,88. Out of 196, 5.6% (11/196) samples gave an error result on QIAreach-QFT and 4.1% (8/196) samples gave indeterminate result on QFT-plus. The TTR for QIAreach QFT positive samples varied from 210–1200 seconds (20 min) and significantly correlated with IFN-γ level of QFT-Plus. QIAreach QFT could be considered an accurate and reliable point-of-need test to diagnose TB infection helping to achieve the WHO End TB programme goals even in decentralised settings where laboratory expertise and infrastructure may be limited.

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Section: Discussionsupporting

confidence: 84%

“…QIAreach QFT leverage the same technology as the TB2 tube of QFT-Plus, is portable, simple to perform and requires only 1 ml of blood from each patient [14,29,[31][32][33].…”

Section: Introductionmentioning

confidence: 99%

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First evaluation of the performance of portable IGRA, QIAreach® QuantiFERON®-TB in intermediate TB incidence setting

et al. 2023

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“…Eight tests could be performed in a single run in 3–20 min, providing qualitative positive or negative results [ 59 , 60 ]. This assay shows comparable results with QFT ® -Plus [ 59 , 60 , 61 ] and is suitable to be implemented in high-prevalence, low-resource settings [ 62 ]. Further studies are needed to accurately evaluate its performance in different populations, particularly in immunocompromised patients, children, and people living with HIV [ 61 ].…”

Section: Screening Tests For Tbimentioning

confidence: 99%

“…In mycobacterial infections, IFN-γ released by CD4 + T cells is essential for host survival and enhances both CD4 + and CD8 + T cell activities [ 129 ]. However, false-negative IGRA results were detected in patients with TB infection with advanced age [ 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , …”

Section: Evaluation Of Host-derived Biomarkersmentioning

confidence: 99%

Challenges and the Way forward in Diagnosis and Treatment of Tuberculosis Infection

et al. 2023

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Globally, it is estimated that one-quarter of the world’s population is latently infected with Mycobacterium tuberculosis (Mtb), also known as latent tuberculosis infection (LTBI). Recently, this condition has been referred to as tuberculosis infection (TBI), considering the dynamic spectrum of the infection, as 5–10% of the latently infected population will develop active TB (ATB). The chances of TBI development increase due to close contact with index TB patients. The emergence of multidrug-resistant TB (MDR-TB) and the risk of development of latent MDR-TB has further complicated the situation. Detection of TBI is challenging as the infected individual does not present symptoms. Currently, there is no gold standard for TBI diagnosis, and the only screening tests are tuberculin skin test (TST) and interferon gamma release assays (IGRAs). However, these tests have several limitations, including the inability to differentiate between ATB and TBI, false-positive results in BCG-vaccinated individuals (only for TST), false-negative results in children, elderly, and immunocompromised patients, and the inability to predict the progression to ATB, among others. Thus, new host markers and Mtb-specific antigens are being tested to develop new diagnostic methods. Besides screening, TBI therapy is a key intervention for TB control. However, the long-course treatment and associated side effects result in non-adherence to the treatment. Additionally, the latent MDR strains are not susceptible to the current TBI treatments, which add an additional challenge. This review discusses the current situation of TBI, as well as the challenges and efforts involved in its control.

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Advances in TB testing

Pagaduan

Altawallbeh

2023

Advances in Clinical Chemistry

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QIAreach QuantiFERON-TB for the diagnosis ofMycobacterium tuberculosisinfection

Abstract: It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online.

Cited by 16 publications

References 12 publications

First evaluation of the performance of portable IGRA, QIAreach® QuantiFERON®-TB in intermediate TB incidence setting

First evaluation of the performance of portable IGRA, QIAreach® QuantiFERON®-TB in intermediate TB incidence setting

Challenges and the Way forward in Diagnosis and Treatment of Tuberculosis Infection

Advances in TB testing

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