Whole Blood Interferon-γ Release Assay Is Insufficient for the Diagnosis of Sputum Smear Negative Pulmonary Tuberculosis

Park, HeeJin; Shin, Junga; Kim, Hyung Jung; Ahn, Chul Min; Chang, Yoon Soo

doi:10.3349/ymj.2014.55.3.725

Cited by 8 publications

(3 citation statements)

References 17 publications

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“…In the small group of UMRs assessed here, no cases of active tuberculosis were identified by chest x-ray, which is a standard screening tool for active pulmonary tuberculosis for migrants coming to Germany. Although some authors describe that the sensitivity of gamma-interferon release assays is higher than that of chest x-ray for the diagnosis of active pulmonary tuberculosis in sputum-negative patients [ 24 ], a recent literature review indicated that chest x-rays have acceptable to good sensitivity for the diagnosis of pulmonary tuberculosis [ 25 ]. Further, the positive predictive value of gamma-interferon release assays for the diagnosis of active tuberculosis is low for patients from high-endemicity settings because positive results can also be expected in cases of latent or cured tuberculosis [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

Microbiological screenings for infection control in unaccompanied minor refugees: the German Armed Forces Medical Service’s experience

et al. 2017

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BackgroundThe German Military Medical Service contributed to the medical screening of unaccompanied minor refugees (UMRs) coming to Germany in 2014 and 2015. In this study, a broad range of diagnostic procedures was applied to identify microorganisms with clinical or public health significance. Previously, those tests had only been used to screen soldiers returning from tropical deployments. This instance is the first time the approach has been studied in a humanitarian context.MethodsThe offered screenings included blood cell counts, hepatitis B serology and microscopy of the stool to look for protozoa and worm eggs as well as PCR from stool samples targeting pathogenic bacteria, protozoa and helminths. If individuals refused certain assessments, their decision to do so was accepted. A total of 219 apparently healthy male UMRs coming from Afghanistan, Egypt, Somalia, Eritrea, Syria, Ghana, Guinea, Iran, Algeria, Iraq, Benin, Gambia, Libya, Morocco, Pakistan, and Palestine were assessed. All UMRs who were examined at the study department were included in the assessment.ResultsWe detected decreasing frequencies of pathogens that included diarrhoea-associated bacteria [Campylobacter (C.) jejuni, enteropathogenic Escherichia (E.) coli (EPEC), enterotoxic E. coli (ETEC), enteroaggregative E. coli (EAEC), enteroinvasive E. coli (EIEC)/Shigella spp.), Giardia (G.) duodenalis, helminths (comprising Schistosoma spp., Hymenolepis (H.) nana, Strongyloides (S.) stercoralis] as well as hepatitis B virus. Pathogenic microorganisms dominated the samples by far. While G. duodenalis was detected in 11.4% of the assessed UMRs, the incidence of newly identified cases in the German population was 4.5 cases per 100,000 inhabitants.ConclusionsWe conclude that the applied in-house PCR screening systems, which have proven to be useful for screening military returnees from tropical deployments, can also be used for health assessment of immigrants from the respective sites. Apparently healthy UMRs may be enterically colonized with a broad variety of pathogenic and apathogenic microorganisms. Increased colonization rates, as shown for G. duodenalis, can pose a hygiene problem in centralized homes for asylum seekers.

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Section: Discussionmentioning

confidence: 99%

Microbiological screenings for infection control in unaccompanied minor refugees: the German Armed Forces Medical Service’s experience

et al. 2017

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“…Some studies indicated that the T-SPOT.TB assay is a promising diagnostic test for active PTB,[ 6 7 8 ] but other studies showed that IGRA was insufficient for the diagnosis of PTB. [ 9 10 ] In this study, we conducted a large retrospective multicenter investigation in China to further evaluate the use of IGRA in the diagnosis of active PTB in high TB-epidemic populations and the factors affecting the performance of the assay.…”

Section: Introductionmentioning

confidence: 99%

Interferon-Gamma Release Assay is Not Appropriate for the Diagnosis of Active Tuberculosis in High-Burden Tuberculosis Settings

Kang

Wang

M³

et al. 2018

Chinese Medical Journal

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Background:Interferon-gamma release assay (IGRA) has been used in latent tuberculosis (TB) infection and TB diagnosis, but the results from different high TB-endemic countries are different. The aim of this study was to investigate the value of IGRA in the diagnosis of active pulmonary TB (PTB) in China.Methods:We conducted a large-scale retrospective multicenter investigation to further evaluate the role of IGRA in the diagnosis of active PTB in high TB-epidemic populations and the factors affecting the performance of the assay. All patients who underwent valid T-SPOT.TB assays from December 2012 to November 2015 in six large-scale specialized TB hospitals in China and met the study criteria were retrospectively evaluated. Patients were divided into three groups: Group 1, sputum culture-positive PTB patients, confirmed by positive Mycobacterium tuberculosis sputum culture; Group 2, sputum culture-negative PTB patients; and Group 3, non-TB respiratory diseases. The medical records of all patients were collected. Chi-square tests and Fisher's exact test were used to compare categorical data. Multivariable logistic analyses were performed to evaluate the relationship between the results of T-SPOT in TB patients and other factors.Results:A total of 3082 patients for whom complete information was available were included in the investigation, including 905 sputum culture-positive PTB cases, 914 sputum culture-negative PTB cases, and 1263 non-TB respiratory disease cases. The positive rate of T-SPOT.TB was 93.3% in the culture-positive PTB group and 86.1% in the culture-negative PTB group. In the non-PTB group, the positive rate of T-SPOT.TB was 43.6%. The positive rate of T-SPOT.TB in the culture-positive PTB group was significantly higher than that in the culture-negative PTB group (χ2 = 25.118, P < 0.01), which in turn was significantly higher than that in the non-TB group (χ2 = 566.116, P < 0.01). The overall results were as follows: sensitivity, 89.7%; specificity, 56.37%; positive predictive value, 74.75%; negative predictive value, 79.11%; and accuracy, 76.02%.Conclusions:High false-positive rates of T-SPOT.TB assays in the non-TB group limit the usefulness as a single test to diagnose active TB in China. We highly recommend that IGRAs not be used for the diagnosis of active TB in high-burden TB settings.

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“…Fourteen studies [ 2 – 10 , 23 – 27 ] reported the diagnostic accuracy of QFT-GIT, while 5 studies [ 10 , 25 , 26 , 28 , 29 ] reported the diagnostic accuracy of T-SPOT.TB. No study of QFT-GIT-plus was identified.…”

Section: Resultsmentioning

confidence: 99%

Diagnostic accuracy of interferon-gamma release assays for diagnosis of smear-negative pulmonary tuberculosis: a systematic review and meta-analysis

et al. 2022

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Introduction The diagnosis of smear-negative pulmonary tuberculosis (SNPTB) is challenging. Interferon gamma-release assays (IGRAs) may be helpful in early diagnosis among these patients resulting in prompt treatment and favorable outcomes. Methods We performed a comprehensive search from each databases’ inception to April 5, 2021. The studies that provided sufficient data regarding the sensitivity and specificity of IGRAs included QuantiFERON-TB Gold In-Tube (QFT-GIT), T-SPOT.TB, or QuantiFERON-TB Gold Plus for diagnosis of SNPTB were included. Results Of 1,312 studies screened, 16 studies were included; 11 QFT-GIT, 2 T-SPOT.TB, and 3 QFT-GIT and T-SPOT.TB. For diagnosis of SNPTB, QFT-GIT had sensitivity of 0.77 (95% CI 0.71–0.82), specificity of 0.70 (95% CI 0.58–0.80), diagnostic odds ratio (DOR) of 8.03 (95% CI 4.51–14.31), positive likelihood ratio (LR) of 2.61 (95% CI 1.80–3.80), negative LR of 0.33 (95% CI 0.25–0.42), and area under receiver operating characteristic (AUROC) of 0.81 (95% CI 0.77–0.84). T-SPOT.TB had sensitivity of 0.74 (95% CI 0.71–0.78), specificity of 0.71 (95% CI 0.49–0.86), DOR of 6.96 (95% CI 2.31–20.98), positive LR of 2.53 (95% CI 1.26–5.07), negative LR of 0.36 (95% CI 0.24–0.55), and AUROC of 0.77 (95% CI 0.73–0.80). The specificity seemed lower in the subgroup analyses of studies from high tuberculosis burden counties compared to the studies from low tuberculosis burden. Conclusion IGRAs do have insufficient diagnostic performance for SNPTB. However, the tests are still helpful to exclude tuberculosis among patients with low pre-test probability. Registry: PROSPERO: CRD42021274653.

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Whole Blood Interferon-γ Release Assay Is Insufficient for the Diagnosis of Sputum Smear Negative Pulmonary Tuberculosis

Cited by 8 publications

References 17 publications

Microbiological screenings for infection control in unaccompanied minor refugees: the German Armed Forces Medical Service’s experience

Microbiological screenings for infection control in unaccompanied minor refugees: the German Armed Forces Medical Service’s experience

Interferon-Gamma Release Assay is Not Appropriate for the Diagnosis of Active Tuberculosis in High-Burden Tuberculosis Settings

Diagnostic accuracy of interferon-gamma release assays for diagnosis of smear-negative pulmonary tuberculosis: a systematic review and meta-analysis

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