• Tuberculosis and Respiratory Diseases
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• v.62 no.4
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• pp.270-275
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• 2007

The QuantiFERON-TB Gold assay and tuberculin skin test (TST) have been useful test for diagnosing latent tuberculosis infections (LTBI). However, there are few reports on the efficacy of the QuantiFERON-TB Gold assay and TST in evaluating the response after the treatment of LTBI. This study examined the changes in the TST and QuantiFERON-TB Gold assay before and after a treatment for latent tuberculosis in health care workers (HCWs) at a local tertiary hospital. Methods: A cohort of volunteers working as nurses and doctors who underwent a TST and QuantiFERON-TB Gold assay was established. The volunteers positive for the QuantiFERON-TB Gold assay had been treated with 3 months of isoniazid (INH) and rifampin (RFP). After completing treatment, the TST and QuantiFERON-TB Gold assay were repeated. Results: Of the 48 participants (14 doctors, 34 nurses, M: F=11:37, mean $age=29.9{\pm}5.5$ years, mean employment $period=74.9{\pm}64.3$ months), 19 (39.6%) tested positive to the TST (mean induration=$19.1{\pm}9.7mm$) and 8 (16.7%) were QuantiFERON-TB Gold assay. Among them, one had active pulmonary tuberculosis. Seven volunteers were consistently positive to both the TST and QuantiFERON-TB Gold assay after being medicated with INH and RFP for 3 months. Conclusion: TST and QuantiFERON-TB Gold assay are unsuitable for evaluating the treatment response of LTBI because they were consistently positive both before and after the anti-tuberculosis medication.

• Tuberculosis and Respiratory Diseases
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• v.66 no.1
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• pp.13-19
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• 2009

Background: The interferon-gamma assay is reported to have high sensitivity and specificity for making the diagnosis of latent tuberculosis infection. The clinical usefulness of this essay for detecting active tuberculosis has not fully defined. We evaluated the diagnostic value of the commercial interferon-gamma assay kit (QuantiFERONTB GOLD) for patients with suspected tuberculosis. Methods: From January to August 2007, we recruited 52 patients with suspected tuberculosis infection. We performed chest X-ray, sputum smear, culture, PCR and the QuantiFERON-TB GOLD test. Pleural fluid analysis and pleural biopsy were also done for the patients with pleural effusion. Results: Of the 52 patients we studied, 30 patients had a positive QuantiFERON-TB GOLD test result. 35 patients were finally diagnosed with active tuberculosis: twenty-five with a positive QuantiFERON-TB GOLD test and 10 with a negative QuantiFERON-TB GOLD test. The sensitivity of the QuantiFERON-TB GOLD test was 71.4% and the specificity was 64.7%. The positive predictive value was 0.83 and the negative predictive value was 0.50. There was no significant difference of any of the clinical and laboratory characteristics between the two groups of patients except the C-reactive protein (CRP) level. The CRP level was 29.2${\pm}$27.3 mg/dL in the pulmonary tuberculosis patients with a positive QuantiFERON-TB GOLD test and 72.9${\pm}$67.9 mg/dL in the patients with a negative QuantiFERON-TB GOLD test (p<0.05). Conclusion: The sensitivity and specificity of the QuantiFERON-TB GOLD test were inadequate for making the diagnosis of active tuberculosis. We suggest that the QuantiFERON-TB GOLD test should not be used by itself to exclude the diagnosis of active tuberculosis. The relationship of the QuantiFERON-TB GOLD test and the CRP level in patients with TB would be further investigated.

• Pediatric Infection and Vaccine
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• v.15 no.1
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• pp.52-58
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• 2008

Purpose : Whole blood interferon-$\gamma$ assay was developed and many studies showed its usefulness in diagnosing tuberculosis (TB) including latent tuberculosis infection (LTBI). However, assessment in children has been limited. This study was undertaken to evaluate the usefulness of QuantiFERON-TB Gold for the diagnosis of LTBI in children exposed to pulmonary TB. Methods : Children who visited Seoul National University Bundang Hospital with a history of TB exposure were enrolled from January 2006 to December 2007. They were evaluated with chest x-rays, tuberculin skin test (TST) and QuantiFERON-TB Gold test. TST was retested 3 months later for those with initial negative reactivity. Definition of LTBI was made on the basis of the TST reactivity. Results : Among the 103 children with a history of TB exposure, 49 children were tested with chest x-ray, TST, and QuantiFERON-TB Gold. Twenty-two were males. Median age was 7.5 years (range; 3 months to 14.7 years). According to TST reactivity, LTBI was in 8 (19%), no infection was in 21 (50%), possible LTBI was in 13 (31%). QuantiFERON-TB Gold test was positive in 5 of the 49 subjects (10%); 3 of the 13 subjects (23.1%) in unknown status, 1 of the 8 subjects (13%) in LTBI, and 1 of the 21 subjects (5%) without infection. The agreement between the QuantiFERON-TB Gold and the TST was poor (${\kappa}=0.101$). Conclusion : QuantiFERON-TB Gold showed poor sensitivity for the diagnosis of LTBI in children with exposure to TB. QuantiFERON-TB Gold alone does not seem to be useful in the diagnosis of LTBI in children.

• Tuberculosis and Respiratory Diseases
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• v.73 no.3
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• pp.143-150
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• 2012

Background: The release of interferon-gamma (IFN-${\gamma}$) by T lymphocytes increases after rechallenge with Mycobacterium tuberculosis antigen, especially, at a localized site of tuberculosis (TB) infection. We aimed to compare the clincial efficacy of two commercial IFN-${\gamma}$ release assays from pleural fluid for the diagnosis in tuberculous pleurisy. Methods: We performed T-SPOT.TB and QuantiFERON-TB Gold tests simultaneously on pleural fluid and peripheral blood samples from patients with pleural effusion, in South Korea, an area with intermediate TB burden. Results: Thirty-six patients were enrolled prospectively, and tuberculous pleurisy was found in 21 patients. Both the numbers of IFN-${\gamma}$ secreting T cells and the concentration of IFN-${\gamma}$ were greater in the pleural tuberculous group, comparing with the non-tuberculous group. Moreover, in the tuberculous group, there was a significant difference in IFN-${\gamma}$ producing spot-forming cells using the T-SPOT.TB method between pleural fluid and peripheral blood. The receiver operating characteristic (ROC) curve, was the greatest for pleural fluid T-SPOT.TB test, followed by peripheral blood T-SPOT.TB test, peripheral blood QuantiFERON-TB Gold test, and pleural fluid QuantiFERON-TB Gold test (area under the ROC curve of 0.956, 0.890, 0.743, and 0.721, respectively). The T-SPOT.TB assay produced less indeterminate results than did QuantiFERON-TB Gold assay in both pleural fluid and peripheral blood. Conclusion: These findings suggest that the pleural fluid T-SPOT.TB test could be the most useful test among the IFN-${\gamma}$ release assays for diagnosing tuberculous pleurisy in an area with an intermediate prevalence of TB infection.

• Pediatric Infection and Vaccine
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• v.20 no.1
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• pp.17-27
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• 2013

Purpose: Recently, two tests are commercially available for the identification of latent tuberculosis infection (LTBI): tuberculin skin test (TST) and interferon-${\gamma}$ release assay (IGRA). Due to its false positiveness, TST tends to be preferred by IGRA until now. In our study, we simultaneously performed both TST and QuantiFERON$^{(R)}$-TB Gold In-Tube (QFT-GIT) and compared their results. Methods: TST and QFT-GIT were done for the diagnosis of LTBI among children who visited pediatric out-patient clinic at St. Vincent's Hospital, The Catholic University of Korea from February of 2007 to May of 2008. The study group was stratified into two groups in terms of whether there was intrafamilial contact or not. Results: Out of total 35 children, 29 were tuberculosis (TB)-exposed cases and the remainders were diagnosed as clinical pulmonary TB. Among these 29 children, TST was positive 38.9% (7/18) for the intrafamilial and 45.5% (5/11) for the nonintrafamilial, and at the same time, the result for QFT-GIT was positive 5.6% (1/18) and 9.1% (1/11), respectively which implies that TST was more sensitive than QFT-GIT. Among 29 TB-exposed cases, 26 initially went through TST and QFTGIT together on their first visit to out-patient clinic, and 15 continued the follow-up tests. Out of total 41 cases collected, the agreement (known as kappa value) was 0.063 which was relatively low. Including 6 cases with pulmonary TB who were all positive for TST and only 5 being positive for QFT-GIT, the final kappa value was 0.334. Conclusion: In our study, the agreement for TST and QFT-GIT was low, and the majorities were almost the cases of positive TST. In current situation with lacking a gold standard test and limited data on children to adolescents, this result is quite alarming that the recent trend tends to replace TST by QFT-GIT when diagnosing LTBI.

• Pediatric Infection and Vaccine
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• v.17 no.2
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• pp.137-147
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• 2010

Purpose : The purpose of this study is to evaluate the usefulness and limitation of QuantiFERON-TB Gold (QTB) for diagnosis of latent tuberculosis in children. Methods : The medical records of 112 children who were tested by tuberculin skin test (TST) and QTB for detection of latent tuberculosis (TB) in Eulji General Hospital during the period from January 2007 to June 2009 were retrospectively reviewed. Results : Of the 112 participants, the clinical TB group included 15 (13.4%), the contact group included 43 (38.4%), and the non-contact group included 54 (48.2%). Positive rates of TST and QTB were 100% and 80% in the clinical TB group, 64% and 14% in the close contact group, 27% and 0% in the casual contact group, and 52% and 2% in the non-contact group, respectively. Sensitivity of QTB was 80.0% and specificity was 92.6%. Agreement between QTB and TST was poor ($\kappa$=0.209). We also confirmed that the positive rate of QTB increased as the age of the patient increased (P=0.011). A QTB indeterminate result was observed in 11 (9.8%) subjects. QTB was retested in 15 subjects. In 5 of the 6 subjects who had positive results initially, positive results persisted for a median 2.2 months after termination of treatment. Conclusion : Although QTB was associated with several problems, including low sensitivity and a high rate of indeterminate results, it had clinical importance due to its high specificity. We found good correlation with regard to exposure and QTB positivity, including that of young children under 5 years of age. However, clinical application of interferon-$\gamma$ releasing assay for young children for diagnosis of active and latent tuberculosis will require additional prospective studies.

• Biomedical Science Letters
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• v.24 no.2
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• pp.138-142
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• 2018

The incidence of tuberculosis (TB) in the Republic of Korea remains high when compared to the incidence in other Organization for Economic Cooperation and Development (OECD) countries. The prompt diagnosis and effective treatment of latent TB infection (LTBI) are very important in terms of controlling the burden of TB. The tuberculin skin test (TST) has long been the "gold standard" assay for the diagnosis of LTBI. However, it can show false positive results due to Bacille Calmette-$Gu{\acute{e}}rin$ (BCG) vaccination and infection with many environmental nontuberculous mycobacteria (NTM). The interferon gamma release assay (IGRA) using Mycobacterium tuberculosis (MTB)-specific antigens, was developed for the detection of LTBI. The QuantiFERON-TB Gold In-Tube assay is one of the most commonly used forms of the IGRA. In order to compare the diagnostic efficacy of the TST and IGRA in relation to LTBI among BCG-vaccinated healthy donors, whole blood samples were collected from 51 participants, and the results of the TST and IGRA were compared. Of the 51 cases, 18 cases (35.3%) were positive and 33 cases (64.7%) were negative when using the TST, while four cases (7.8%) were positive and 47 cases (92.2%) negative when using the IGRA. There was no correlation between the size of the induration in the TST and the $IFN-{\gamma}$ protein level. In conclusion, the TST showed higher cross-reactivity among the BCG-vaccinated healthy participants, therefore, the IGRA might be the most suitable assay for the rapid screening of LTBI in BCG-vaccinated healthy population, or for TB contact investigation.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.27 no.3
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• pp.238-244
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• 2017

Objectives: The major objective of this study was to investigate the prevalence of and risk factors for latent tuberculosis infection (LTBI) among employees at a workers' compensation hospital. Methods: Among the 394 employees at Incheon Hospital, 362 were enrolled in the study. An interferon-gamma release assay(IGRA) for diagnosis of LTBI was performed using QuantiFERON$^{(R)}$ TB Gold In-Tube(QFT-IT). Risk factors for LTBI were analyzed using logistic regression analysis. Results: The overall prevalence of LTBI was 32.0%(116/362). The non-medical departments have a significantly high prevalence compared to medical departments(39.7% vs 23.2%). In multivariate logistic regression analysis, experience working in the pneumoconiosis hospital(OR, 3.6; 95% CI, 1.3-10.3) was associated with development of LTBI. Conclusions: Korean guidelines for the management of tuberculosis recommend annual regular health examinations for TB and LTBI for health care workers(HCWs). Considering the high prevalence of and risk factors for LTBI among non-HCWs, it suggests a need for annual regular health examinations for TB and LTBI for all employees at workers' compensation hospitals, including pneumoconiosis hospitals.

• Tuberculosis and Respiratory Diseases
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• v.81 no.1
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• pp.59-72
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• 2018

Background: It remains uncertain if $interferon-{\gamma}$ release assays (IGRAs) are superior to the tuberculin skin test (TST) for the diagnosis of active tuberculosis (TB) or latent tuberculosis infection (LTBI) in immunosuppressed populations including people with human immunodeficiency virus (HIV) infection. The purpose of this study was to systematically review the performance of IGRAs and the TST in people with HIV with active TB or LTBI in low and high prevalence TB countries. Methods: We searched the MEDLINE database from 1966 through to January 2017 for studies that compared results of the TST with either the commercial QuantiFERON-TB Gold in Tube (QFTGT) assay or previous assay versions, the T-SPOT.TB assay or in-house IGRAs. Data were summarized by TB prevalence. Tests for concordance and differences in proportions were undertaken as appropriate. The variation in study methodology was appraised. Results: Thirty-two studies including 4,856 HIV subjects met the search criteria. Fourteen studies compared the tests in subjects with LTBI in low TB prevalence settings. The QFTGT had a similar rate of reactivity to the TST, although the first-generation version of that assay was reactive more commonly. IGRAs were more frequently positive than the TST in HIV infected subjects with active TB. There was considerable study methodology and population heterogeneity, and generally low concordance between tests. Both the TST and IGRAs were affected by CD4 T-cell immunodeficiency. Conclusion: Our review of comparative data does not provide robust evidence to support the assertion that the IGRAs are superior to the TST when used in HIV infected subjects to diagnose either active TB or LTBI.

• Pediatric Infection and Vaccine
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• v.23 no.2
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• pp.94-101
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• 2016

Purpose: This study aimed to describe the results of a contact investigation on health care workers after exposure to a house officer with smear-positive pulmonary tuberculosis (TB). Methods: Eighty nine out of 101 subjects who had close contact with the index patient agreed to be enrolled in the investigation. The first contact investigation was conducted approximately 30 days after the index patient's onset of symptoms, followed by the second investigation after 10 weeks. In both, clinical manifestations were studied, and chest X-ray and tuberculin skin test (TST)/QuantiFERON-TB Gold (QFT-G) in dual screening strategy were conducted. Results: The first TST resulted in positive in 34 subjects (38.2%). QFT-G was conducted on 16 subjects who tested positive in the first TST and aged under 36. Six of them (37.5%) were positive. The second TST was conducted on 41 subjects with negative results in the first TST. Seventeen (41.5%) were positive and among them, three (17.6%) showed positive QFT-G. None of the subjects were diagnosed with active TB. The probability of TB infection through contact with the index patient was 7.3% (3/41) in dual screening strategy while it was 41.5% (17/41) in TST strategy. Conclusions: This first hospital-setting contact investigation for tuberculosis in Korea revealed that latent tuberculosis infection (LTBI) rates vary depending on different diagnostic strategies. This indicates the need for systematic guidelines for diagnosing LTBI in health care workers who have professional exposure to TB.