Comparison of Two Tuberculosis Infection Tests in a South American Tertiary Hospital: STANDARD F TB-Feron FIA vs. QIAreachTM QuantiFERON-TB

Saint-Pierre, Gustavo; Conei, Daniel; Cantillana, Patricia; Raijmakers, Mariella; Vera, Antonio; Gutiérrez, Daniela; Kennedy, Cristopher; Peralta, Paulina; Ramonda, Paulina

doi:10.3390/diagnostics13061162

Cited by 3 publications

(2 citation statements)

References 15 publications

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“…Following the screening of titles and abstracts, 23 papers were selected for full-text reviews, and ultimately, six of those articles met the inclusion criteria for this study 15 , 20 – 24 . One study was excluded from the analysis due to its focus on the comparison of STANDARD F TB-Feron FIA vs. QIAreach QFT, which did not align with the criteria set for inclusion in the study 25 . In the Ntshiqa et al .…”

Section: Resultsmentioning

confidence: 99%

Evaluating the diagnostic accuracy of QIAreach QuantiFERON-TB compared to QuantiFERON-TB Gold Plus for tuberculosis: a systematic review and meta-analysis

Mahmoudi,

Nourazar

2024

Sci Rep

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Accurate tuberculosis (TB) diagnosis remains challenging, especially in resource-limited settings. This study aims to assess the diagnostic performance of the QIAreach QuantiFERON-TB (QFT) assay, with a specific focus on comparing its diagnostic performance with the QuantiFERON-TB Gold Plus (QFT-Plus). We systematically reviewed relevant individual studies on PubMed, Scopus, and Web of Science up to January 20, 2024. The focus was on evaluating the diagnostic parameters of the QIAreach QFT assay for TB infection, which included sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), negative likelihood ratio (NLR), and concordance with the QFT-Plus assay. QIAreach QFT demonstrated strong diagnostic performance with a pooled sensitivity of 99% (95% CI 95–100%) and specificity of 94% (95% CI 85–97%). Additionally, it showed a PLR of 15.6 (95% CI 6.5–37.5) and NLR of 0.01 (95% CI 0–0.03). The pooled PPV and NPV were 88% (95% CI 70–98%) and 100% (95% CI 99–100%), respectively. Concordance analysis with QFT-Plus revealed a pooled positive percent agreement of 98% (95% CI 88–100%) and pooled negative percent agreement of 91% (95% CI 81–97%), with a pooled overall percent agreement of 92% (95% CI 83–98). In conclusion, QIAreach QFT has shown promising diagnostic performance, with a strong concordance with QFT-Plus. However, further studies are needed to comprehensively evaluate its diagnostic performance in the context of TB infection.

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Section: Resultsmentioning

confidence: 99%

Evaluating the diagnostic accuracy of QIAreach QuantiFERON-TB compared to QuantiFERON-TB Gold Plus for tuberculosis: a systematic review and meta-analysis

Mahmoudi,

Nourazar

2024

Sci Rep

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“…Therefore, it is important to prevent the incidence and transmission of TB. Additionally, treatment of LTBI has been exposed to lessen the possibility of progression to active TB (Jonas et al, 2023;Saint-Pierre et al, 2023).…”

Section: Introductionmentioning

confidence: 99%

Analysis of Interferon-Gamma Release Assay Results for Latent Tuberculosis Infection Diagnosis at a Referral Clinical Laboratory in South Korea

Kim,

Lee

et al. 2023

American Journal of Biochemistry and Biotechnology

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The world health organization states that individuals with Latent Tuberculosis Infection (LTBI) are infected with Tuberculosis (TB) bacteria but do not show symptoms of active disease. However, they are at possibility of developing vigorous TB and potentially transmitting the illness to others. In 2018, South Korea reported a 14.8% positivity rate in LTBI screening, with higher rates observed among older individuals, those with lower incomes and women. Furthermore, approximately one in four people worldwide has LTBI. LTBI within certain groups is often the result of prolonged, cumulative and close contact with infected individuals. In this study, we aimed to analyze the current scenario regarding LTBI in South Korea, where large groups are being tested utilizing the Interferon-Gamma Release Assay (IGRA). From 2019-2022, 219,459 cases with IGRA results obtained from a referral clinical laboratory in Yongin city were investigated. This research was accepted by the Institutional Review Board (IRB) of Dankook university. The specimens were collected in QuantiFERON® gold plus Tubes (TB) (Qiagen GmbH, Hilden, Germany) and interferon-gamma activity was measured using an enzyme-linked immunosorbent assay (Dynex technologies, Inc., Chantilly, Virginia, USA). multinomial logistic regression analysis was performed to study the association among age, sex and LTBI confirmed by IGRAs. The p-value for sex was less than 0.001, indicating a significantly higher positivity rate in women than that in men. Additionally, the positivity rate decreased in both sexes from 2019-2022. Notably, the highest positivity rates were observed in 50-59-year age set, with men at 1.32% and women at 2.33%. As testing frequency increased, the probability of detecting positive results also increased. Continuous IGRA testing is recommended for individuals in the 50-59-year age group. Regular and extensive testing is recommended for healthcare workers, military personnel, prisoners and students. Therefore, the pros and cons of IGRA can be analyzed and it is believed that it can be helpful for public health.

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Low concordance between QIAreach QuantiFERON-TB, a novel interferon-gamma release assay, and QuantiFERON-TB Gold Plus, in a population-based survey in Blantyre, Malawi

Rickman,

Phiri,

Mbale

et al. 2024

J Clin Microbiol

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Urgent improvements in the diagnosis and management of Mycobacterium tuberculosis infection are required to reach End TB goals. Conventional interferon-gamma release assays (IGRAs), such as QuantiFERON-TB Gold Plus (QFT-Plus), require substantial laboratory infrastructure and large blood volumes, limiting use in high-burden settings. The QIAreach QuantiFERON-TB (QIAreach QFT) was developed to overcome these challenges but has not previously been evaluated in field conditions in a low-income, high-burden country, or at scale in children. We performed a diagnostic evaluation of QIAreach QFT against QFT-Plus, in a cross-sectional IGRA survey in Blantyre, Malawi. We recruited a population-representative sample of children aged 1–4 years and adolescents and adults aged 10–40 years, from households and primary care. We calculated sensitivity, specificity, and Cohen’s kappa for QIAreach QFT against QFT-Plus, and constructed Bayesian hurdle-categorical models to compare quantitative test results. A total of 1,049 participants were recruited (64%: 1–4 years; 13%: 10–19 years; and 23%: 20–40 years). More participants had a positive QIAreach QFT result (32%) compared to QFT-Plus (15%). Over half of positive QIAreach QFT results had time-to-positivity of exactly 20 min, the assay cutoff. There was minimal agreement between QFT-Plus and QIAreach QFT results ( κ = 0.26), which was lowest in children aged 1–4 years ( κ = 0.13). Sensitivity and specificity of QIAreach QFT relative to QFT-Plus were 62% and 74%, respectively, with poor correlation between quantitative results. The suboptimal performance of QIAreach QFT, particularly in young children, suggests that it cannot currently be recommended for wider use and that the urgent need for an accessible test of Mtb infection remains unmet. IMPORTANCE Almost a quarter of the world’s population has evidence of Mycobacterium tuberculosis (Mtb) infection. Monitoring and addressing this substantial burden of so-called “latent” tuberculosis (TB) infection will be critical to reach End TB targets. However, current interferon-gamma release assays (IGRAs) for Mtb infection are costly, and require a large volume of venous blood and significant laboratory processing, which are major barriers to their wider use in low-income countries. The novel QIAreach QuantiFERON-TB (QIAreach) assay has been designed as a more accessible alternative. We sought to evaluate it against a reference standard of QuantiFERON-TB Gold Plus, in a large cross-sectional survey in Blantyre, Malawi. To our knowledge, this is the first diagnostic evaluation of QIAreach QFT to be performed in a population-based survey in a low-income high-incidence setting, and to specifically focus on young children (a priority group for interventions targeting Mtb infection). In contrast to previous studies in other settings, we observed poor performance of QIAreach QFT, particularly in young children where there was little correlation between the novel test and the reference standard. This leads us to conclude that this test cannot be widely recommended for use in its current form; indeed manufacture is currently suspended. We believe our findings are of urgent importance to policymakers, clinicians, and researchers and underscore the importance of careful evaluation of new diagnostics in the contexts where they are intended to be used.

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Comparison of Two Tuberculosis Infection Tests in a South American Tertiary Hospital: STANDARD F TB-Feron FIA vs. QIAreachTM QuantiFERON-TB

Cited by 3 publications

References 15 publications

Evaluating the diagnostic accuracy of QIAreach QuantiFERON-TB compared to QuantiFERON-TB Gold Plus for tuberculosis: a systematic review and meta-analysis

Evaluating the diagnostic accuracy of QIAreach QuantiFERON-TB compared to QuantiFERON-TB Gold Plus for tuberculosis: a systematic review and meta-analysis

Analysis of Interferon-Gamma Release Assay Results for Latent Tuberculosis Infection Diagnosis at a Referral Clinical Laboratory in South Korea

Low concordance between QIAreach QuantiFERON-TB, a novel interferon-gamma release assay, and QuantiFERON-TB Gold Plus, in a population-based survey in Blantyre, Malawi

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