QuantiFERON<sup>®</sup>-TB Gold In-Tube reliability for immigrants with parasitic infections in Boston, USA

Epstein, Rachel; Bhagavathula, Madhuri; Saag, Lauren A.; Verma, Sheetal; Kan, Carolyn; Mesick, Jackson; Kamineni, Phanisyam; White, Laura F.; Barnett, Elizabeth D.; Salgame, Padmini; Hochberg, Natasha S.

doi:10.5588/ijtld.18.0540

Cited by 4 publications

(3 citation statements)

References 24 publications

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“…IGRAs have been developed more recently (13)(14)(15)(16)(17)(18). They are in vitro assays able to measure the blood levels of IFN-γ released by T lymphocytes stimulated with antigenic peptides of M. tuberculosis [14,[17][18][19][20][21][22].…”

Section: Introductionmentioning

confidence: 99%

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: Introductionmentioning

confidence: 99%

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

et al. 2023

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“…The low sensitivity of the QFT-Plus in detecting TB disease cases has been well documented [13][14][15] , particularly in countries with a high prevalence of M. tuberculosis infection and other comorbidities 16,17 , such as Burkina Faso, which was one of our study sites. Additionally, there may be a potential correlation between the low sensitivity of the QFT-Plus and a high frequency of comorbidities, particularly parasitic infections and fecal yeast [18][19][20] , in these patients. Because the sensitivity of the QFT-Plus has been previously determined in countries with a low prevalence of M. tuberculosis infection and other comorbidities, including the US, Japan, and Australia 12 , the low sensitivity and high number of indeterminate results obtained with the QFT-Plus in this study may be due to the particularly poor health status of the Burkina Faso study participants.…”

Section: Discussionmentioning

confidence: 99%

Preliminary diagnostic performance of the VIDAS® TB-IGRA for the detection ofMycobacterium tuberculosisinfection and disease

Diagbouga

Pease

Alcaide

et al. 2022

Preprint

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ImportanceAccurate diagnosis of tuberculosis (TB) infection can be achieved with interferon-γ release assays. Their performance can be improved by utilizing fully automated, single-patient formats.ObjectiveEstablish clinical thresholds for a new interferon-γ release assay, the VIDAS® TB-IGRA, and compare diagnostic performance in detecting tuberculosis infection and disease with the established QuantiFERON-TB Gold Plus (QFT-Plus).DesignPreliminary diagnostic performance study (October 2nd, 2019–February 20th, 2020).SettingMulticenter.ParticipantsParticipants were divided into TB disease, high-risk, and low-risk populations. The confirmed TB disease population included 107 patients. The high-risk population included 162 individuals with flagged risk factors on a questionnaire but without objective clinical confirmation of TB. The Low-risk population included 117 healthy blood donors from the French National Blood Bank.ExposuresTuberculosis.Main Outcomes and MeasuresPositive and negative percent agreement (PPA, NPA) were determined between the VIDAS® TB-IGRA and QFT-Plus. In the TB disease and low-risk populations, sensitivity was also measured against bacterial culture and PCR.ResultsThe VIDAS® TB-IGRA produced fewer indeterminate results than the QFT-Plus (1/107 vs. 23/107) in the TB disease population. One analysis included indeterminate results as false negatives (94 positives and 10 false negatives vs. 56 positives and 48 false negatives), and the VIDAS® TB-IGRA exhibited higher sensitivity than the QFT-Plus (90.4% vs. 53.8%) (p<0.0001). Another analysis excluded indeterminate results (76 positives and 4 false negatives vs. 55 positives and 25 false negatives), and the VIDAS® TB-IGRA again exhibited higher sensitivity than the QFT-Plus (95.0% vs. 68.8%) (p<0.0001). A 98.2% PPA was calculated between the two tests with this dataset.In the high-risk population, the VIDAS® TB-IGRA exhibited a strong PPA (94.4%) with the QFT-Plus. However, a lower than expected NPA was observed (85.2%). In the low-risk population, the VIDAS® TB-IGRA demonstrated high specificity (94.9%) and a strong NPA (98.2%) with the QFT-Plus.Conclusions and RelevanceThe fully automated VIDAS® TB-IGRA is a promising diagnostic test for both TB infection and disease. It exhibits higher sensitivity while maintaining specificity and produces fewer indeterminate interpretations. Its easy-to-use, single-patient format may lead to increased TB testing to help with the worldwide eradication of the disease.KEY POINTSQuestionWhat is the diagnostic performance of the VIDAS® TB-IGRA in detecting tuberculosis infection and disease?FindingsThe VIDAS® TB-IGRA exhibited high sensitivity in individuals with tuberculosis disease (90.4–95.0%), high specificity in healthy blood donors (94.9%), a high positive percent agreement (PPA) in individuals with a high risk of tuberculosis infection (94.4%), and it produced a low number of indeterminate results (1/386).MeaningThe VIDAS® TB-IGRA is a promising diagnostic test for both tuberculosis infection and disease.

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“…A 2020 study of recent Chicago immigrants showed 6.4% and 4.0% seroprevalence for Toxocara and Strongyloides stercoralis [ 55 ]. A Boston study of refugees and asylum seekers in the USA from 2012 to 2017 found 0.2% hookworm infection and 1.9% S. stercoralis infection, [ 56 ]. Though the US Centers for Disease Control and Prevention has established protocols for testing and treating refugee populations in the USA, there are no surveillance protocols currently in place to address these infections in documented or undocumented immigrants [ 55 ].…”

Section: Vulnerable Groupsmentioning

confidence: 99%

Soil-Transmitted Helminths in the USA: a Review of Five Common Parasites and Future Directions for Avenues of Enhanced Epidemiologic Inquiry

2021

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Purpose of Review The aim of this review is to present a comprehensive look at five intestinal soil-transmitted helminths (STHs) of global health importance that may continue to plague low-income and rural areas of the USA and argue the need for enhanced surveillance of these infections, which primarily affect the nation's most vulnerable groups. Recent Findings Human STH infections in middle-and high-income countries are at particular risk for being undiagnosed; as common symptoms are non-specific, differentials require a high index of clinical suspicion, and cases are concentrated in areas of poverty where access to care is limited. Although autochthonous STHs are thought to be rare in the USA, infections were once common in the American South and Appalachia and robust epidemiologic surveillance is limited post 1980s. However, recent community studies and case reports from small-scale farms and areas of high rural or inner-city poverty reveal the potential for persisting helminth infections in distinct populations of the country. Summary STHs are among the most common neglected tropical diseases globally causing significant morbidity in underserved communities and contributing to the continuation of cycles of poverty within vulnerable populations. Due to possible severe disease sequalae and their ability to perpetuate poverty and poverty-associated health outcomes within already vulnerable groups, it is vital that surveillance for these infections is enhanced to bolster health equity in the USA.

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QuantiFERON^®-TB Gold In-Tube reliability for immigrants with parasitic infections in Boston, USA

Cited by 4 publications

References 24 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

Preliminary diagnostic performance of the VIDAS® TB-IGRA for the detection ofMycobacterium tuberculosisinfection and disease

Soil-Transmitted Helminths in the USA: a Review of Five Common Parasites and Future Directions for Avenues of Enhanced Epidemiologic Inquiry

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QuantiFERON®-TB Gold In-Tube reliability for immigrants with parasitic infections in Boston, USA

Cited by 4 publications

References 24 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

Preliminary diagnostic performance of the VIDAS® TB-IGRA for the detection ofMycobacterium tuberculosisinfection and disease

Soil-Transmitted Helminths in the USA: a Review of Five Common Parasites and Future Directions for Avenues of Enhanced Epidemiologic Inquiry

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Product

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QuantiFERON^®-TB Gold In-Tube reliability for immigrants with parasitic infections in Boston, USA