Evaluation of QuantiFERON-TB Gold Plus for Detection of Mycobacterium tuberculosis infection in Japan

Liu, Yi; Sasaki, Yuka; Nagai, Hirokazu; Ishikawa, Satoshi; Takamori, Mikio; Sakashita, Kentaro; Saito, Takefumi; Fukushima, Kiyoyasu; Igarashi, Yuriko; Ando, Akio; Chikamatsu, Kinuyo; Yamada, Hiroyuki; Takaki, Akiko; Mori, Toru; Mitarai, Satoshi

doi:10.1038/srep30617

Cited by 64 publications

(55 citation statements)

References 28 publications

(30 reference statements)

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“…The new CD8+ -specific peptides have been added to increase the sensitivity of the test because it has been shown that Mtb-specific CD8+ T-cells are mainly associated to active TB [44,45,46,47]. The first data on the performance of QuantiFERON TB Plus were reported recently [48,49,50]. When compared with the previous test version of QFT-GIT [50], equal sensitivity of the new generation QFT-plus was observed.…”

Section: Discussionmentioning

confidence: 99%

Use of the QuantiFERON-TB Gold In-Tube Test in the Diagnosis and Monitoring of Treatment Efficacy in Active Pulmonary Tuberculosis

Chang

Wang

Chen

2017

IJERPH

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The value of QuantiFERON in the diagnosis of tuberculosis disease and in the monitoring of the response to anti-tuberculosis treatment is unclear. The aims of this study were to evaluate the accuracy of the QuantiFERON-TB Gold In-Tube (QFT-GIT) test in the diagnosis of tuberculosis and in the monitoring of the response to anti-tuberculosis treatment in patients with active pulmonary tuberculosis (PTB). Between January 2013 and December 2015, 133 cases with active PTB and 133 controls with no mycobacterial infection, matched by age (within 3 years) and by the week that they visited Tainan Chest Hospital, were enrolled in the study. Serial testing by QFT-GIT at baseline and after 2 and 6 months of treatment was performed. At these time points, a comparison of the performance of QFT-GIT with that of sputum culture status among study subjects was conducted. Compared to baseline, 116 (87.2%) cases showed a decreased response, whereas 17 (12.8%) showed persistent or stronger interferon-gamma (IFN-γ) responses at 2 months. PTB patients IFN-γ responses declined significantly from baseline to 2 months (median, 6.32 vs. 4.12; p < 0.005). The sensitivity values of the QFT-GIT test for the detection of pulmonary tuberculosis at cut-off points of 0.35 IU/mL, 0.20 IU/mL, and 0.10 IU/mL were 74.4%, 78.2%, and 80.5%, respectively. The specificity values at cut-off points of 0.35 IU/mL, 0.20 IU/mL, and 0.10 IU/mL were 66.2%, 63.9%, and 57.1%, respectively. Our results support the QFT-GIT assay as a potential tool for diagnosing tuberculosis and for monitoring the efficacy of anti-tuberculosis treatment.

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Section: Discussionmentioning

confidence: 99%

Use of the QuantiFERON-TB Gold In-Tube Test in the Diagnosis and Monitoring of Treatment Efficacy in Active Pulmonary Tuberculosis

Chang

Wang

Chen

2017

IJERPH

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“…It is postulated that the difference in IFN‐γ production between the two antigen tubes (TB2 − TB1) provides an estimate of the specific CD8 response, and this could possibly indicate recent infection and disease activity. The QFT‐Plus has been shown to have high concordance with the QFT‐GIT and to be more strongly associated with exposure . Large‐scale studies are awaited to see if the QFT‐Plus can improve sensitivity and fulfil currently unmet clinical needs in identifying those with active disease, those with recent LTBI and for the monitoring of response to anti‐TB treatment.…”

Section: Diagnostic Tests For Ltbimentioning

confidence: 99%

“…The QFT-Plus has been shown to have high concordance with the QFT-GIT and to be more strongly associated with exposure. 47,48 Large-scale studies are awaited to see if the QFT-Plus can improve sensitivity and fulfil currently unmet clinical needs in identifying those with active disease, those with recent LTBI and for the monitoring of response to anti-TB treatment.…”

Section: New Tests For Ltbimentioning

confidence: 99%

Latent tuberculosis infection: Opportunities and challenges

et al. 2018

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Diagnosing and treating latent tuberculosis (TB) infection (LTBI) is recognized by the World Health Organization as an important strategy to accelerate the decline in global TB and achieve TB elimination. Even among low-TB burden countries that have achieved high rates of detection and successful treatment for active TB, a number of barriers have prevented implementing or expanding LTBI treatment programmes. Of those infected with TB, relatively few will develop active disease and the current diagnostic tests have a low predictive value. LTBI treatment using isoniazid (INH) has low completion rates due to the long duration of therapy and poor tolerability. Both patients and physicians often perceive the risk of toxicity to be greater than the risk of reactivation TB. As a result, LTBI treatment has had a limited or negligible role outside of countries with high resources and low burden of disease. New tools have emerged including the interferon-gamma release assays that more accurately diagnose LTBI, particularly in people vaccinated with Bacillus Calmette-Guerin (BCG). Shorter, better tolerated treatment using rifamycins are proving safe and effective alternatives to INH. While still imperfect, TB prevention using these new diagnostic and treatment tools appear cost effective in modelling studies in the United States and have the potential to improve TB prevention efforts globally. Continued research to understand the host-organism interactions within the spectrum of LTBI is needed to develop better tools. Until then, overcoming the barriers and optimizing our current tools is essential for progressing toward TB elimination.

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“…This was recently suggested in a cohort of 119 patients with active TB (84.9% sensitivity with QFT-Plus TB2 versus 80.7% with TB1) (16). However, follow-up studies directly comparing QFT to QFT-Plus in active TB patients did not show a difference in sensitivity (15,17,18). Furthermore, the sensitivity and specificity of QFT-Plus for LTBI in low-risk individuals, such as low-risk North American HCWs, remains to be determined.…”

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confidence: 93%

Evaluation of QuantiFERON-TB Gold-Plus in Health Care Workers in a Low-Incidence Setting

et al. 2017

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Although launched in 2015, little is known about the accuracy of QuantiFERON-TB Gold-Plus (QFT-Plus) for diagnosis of latent M. tuberculosis infection (LTBI). Unlike its predecessor, QFT-Plus utilizes two antigen tubes to elicit an immune response from CD4 ϩ and CD8 ϩ T lymphocytes. We conducted a crosssectional study in low-risk health care workers (HCWs) at a single U.S. center to compare QFT-Plus to QuantiFERON-TB Gold in-tube (QFT). A total of 989 HCWs were tested with both QFT and QFT-Plus. Risk factors for LTBI were obtained from a questionnaire. QFT-Plus was considered positive if either antigen tube 1 (TB1) or TB2 tested positive, per the manufacturer's recommendations, or if both TB1 and TB2 tested positive, using a conservative definition. Results were compared using Cohen's kappa and linear regression, respectively. Agreement of QFT with QFT-Plus was high, at 95.6% (95% confidence interval [CI], 94.3 to 96.9; kappa, 0.57). The majority of discordant results between QFT and QFT-Plus TB1 (84.8%) and QFT and QFT-Plus TB2 (88.6%) fell within the range of 0.2 to 0.7 IU/ml. The positivity rate in 626 HCWs with no identifiable risk factors and no self-reported history of positive LTBI tests was 2.1% (CI, 1.0 to 3.2) and 3.0% (CI, 1.7 to 4.3) with QFT and QFT-Plus, respectively. A conservative definition of a QFT-Plus-positive result yielded a positivity rate of 1.0% (CI, 0.2 to 1.7; P value of 0.0002 versus QFT-Plus and 0.07 versus QFT). On follow-up testing, of 11 HCWs with discordant QFT-Plus results, 90.9% (10/11) had a negative QFT result. The QFT-Plus assay showed a high degree of agreement with QFT in U.S. HCWs. A conservative interpretation of QFT-Plus eliminated nearly all nonreproducible positive results in low-risk HCWs. Larger studies are needed to validate the latter finding and to more clearly define conditions under which a conservative interpretation can be used to minimize nonreproducible positive results in low-risk populations.

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Evaluation of QuantiFERON-TB Gold Plus for Detection of Mycobacterium tuberculosis infection in Japan

Cited by 64 publications

References 28 publications

Use of the QuantiFERON-TB Gold In-Tube Test in the Diagnosis and Monitoring of Treatment Efficacy in Active Pulmonary Tuberculosis

Use of the QuantiFERON-TB Gold In-Tube Test in the Diagnosis and Monitoring of Treatment Efficacy in Active Pulmonary Tuberculosis

Latent tuberculosis infection: Opportunities and challenges

Evaluation of QuantiFERON-TB Gold-Plus in Health Care Workers in a Low-Incidence Setting

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