Discordance among Commercially Available Diagnostics for Latent Tuberculosis Infection

Mancuso, James D.; Mazurek, Gerald H.; Tribble, David R.; Olsen, Cara; Aronson, Naomi; Geiter, Lawrence; Goodwin, Donald J.; Keep, Lisa W.

doi:10.1164/rccm.201107-1244oc

Cited by 53 publications

(46 citation statements)

References 29 publications

(38 reference statements)

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“…A recent study in military recruits indicated that individuals where all three tests were positive had a higher epidemiologic risk of prior infection, whereas individuals with only one positive test were suggested to be likely false-positive (41). In line with these findings, the percentage of individuals with positive test results in all three assays or with two positive IGRAs in our study was also highest in cases with highest likelihood of exposure.…”

Section: Original Articlesupporting

confidence: 89%

Risk Assessment of Tuberculosis in Immunocompromised Patients. A TBNET Study

Sester

Leth

Bruchfeld

et al. 2014

Am J Respir Crit Care Med

203

168

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Author Contributions: M.S. made a substantial contribution to the conception and design of the work and to the acquisition, analysis, and interpretation of data for the work; wrote the manuscript; critically revised the manuscript for important intellectual content; and gave final approval of the current version to be published. F.v.L. made a substantial contribution to the conception and design of the work and to the interpretation of data for the work, performed statistical analysis, wrote the manuscript, critically revised the manuscript for important intellectual content, and gave final approval of the current version to be published. P.R. made a substantial contribution to the conception and design of the work and to the interpretation of data for the work, critically revised the manuscript for important intellectual content, and gave final approval of the current version to be published. C.L. made a substantial contribution to the conception and design of the work and to the acquisition, analysis, and interpretation of data for the work; wrote the manuscript; critically revised the manuscript for important intellectual content; and gave final approval of the current version to be published. All other authors made a contribution to the acquisition of the data for the work, critically revised the manuscript for important intellectual content, and gave final approval of the current version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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Section: Original Articlesupporting

confidence: 89%

Risk Assessment of Tuberculosis in Immunocompromised Patients. A TBNET Study

Sester

Leth

Bruchfeld

et al. 2014

Am J Respir Crit Care Med

203

168

View full text Add to dashboard Cite

show abstract

“…Previous reports have highlighted differences in sensitivity and specificity in active tuberculosis between the QFT-GIT and the T-SPOT [5,6]. The cross-sectional comparison study among military recruits was performed to assess the agreement between T-SPOT and QFT-GIT for LTBI in USA [7]. It showed kappa value was 0.39, which was similar to our result.…”

Section: Discussionsupporting

confidence: 86%

“…CFP-10 and TB7.7) minus Nil; 5 The interferon gamma concnetration in plasma from blood stimulated with mitogen minus Nil; 6 The interferon gamma concnetration in plasma from blood incubated without antigen, 7 The greater number of spots resulting from stimulation of peripheral blood mononuclear cells (PBMCs) with ESAT-6 minus Nil; 8 The greater number of spots resulting from stimulation of PBMCs with CFP-10 minus Nil; 9 The number of spots resulting from stimulation of PBMCs with mitogen; 10 The number of spots resulting from incubation of PBMCs in culture media without antigens Table 2: The characteristics of 10 cases with the discordance of results between QFT-GIT and T-SPOT…”

Section: T-spot Resultsmentioning

confidence: 99%

Discordance between Two Interferon-Gamma Release Assays in the Diagnosis of Latent Tuberculosis Infection in Healthcare Workers

Fujiwara¹,

Nishimura²,

Iketani³

et al. 2014

J Infect Dis Ther

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Background: Interferon-gamma release assays (IGRAs) more accurately diagnose Mycobacterium tuberculosis (Mtb) infection than the tuberculin skin test. To prevent outbreaks in medical facilities, early detection and treatment of Mtb infection (including latent tuberculosis infection (LTBI)) is important in healthcare workers. Therefore, the IGRAs have considerable utility for Mtb infection control in medical facilities. In Japan, two IGRAs are commercially available, QuantiFERON®-TBGold In-Tube assay (QFT-GIT) and T-SPOT®.TB (T-SPOT). However, it remains unclear if diagnostic yields of LTBI by both IGRAs are equivalent in healthcare workers.

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“…Weighing 4 to 9 months of potentially unnecessary preventive antibiotic therapy (and attendant risk of adverse drug effects) against the probability of reactivation TB, screening programs in low incidence settings may choose to limit false-positives by accepting a higher than recommended threshold for test positivity. Indeed, recognizing the limited positive predictive value of IGRAs in low-risk individuals (41), some centers in the United States have already instituted such policies (42,43). Ultimately, as with the TST, conversion thresholds will depend on risk of future active TB disease, the epidemiologic setting, and, possibly, the magnitude of the quantitative response (44), although establishing the evidence base for such thresholds will be challenging (2).…”

Section: Discussionmentioning

confidence: 99%

Test Variability of the QuantiFERON-TB Gold In-Tube Assay in Clinical Practice

Metcalfe

Cattamanchi

McCulloch

et al. 2013

Am J Respir Crit Care Med

163

107

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Rationale: Although IFN-g release assays (IGRAs) are widely used to screen for Mycobacterium tuberculosis infection in high-income countries, published data on repeatability are limited. Objectives: To determine IGRA repeatability. Methods: The study population included consecutive patients referred to The Methodist Hospital (Houston, TX) between August 1, 2010 and July 31, 2011 for latent tuberculosis (TB) infection screening with an IGRA (QuantiFERON-TB Gold In-Tube; Cellestis, Carnegie, Australia). We performed multiple IGRA tests using leftover stimulated plasma according to a prospectively formulated quality control protocol. We analyzed agreement in interpretation of test results classified according to manufacturer-recommended criteria and repeatability of quantitative TB response. Measurements and Main Results: During the study period, 1,086 test results were obtained from 543 subjects. Per the manufacturer's cutpoint, the result of the second test was discordant from that of the first in 28 (8%) of 366 patients with valid test results, including 13 with an initial negative result and 15 with an initial positive result. Although agreement between repeat test results was high (k ¼ 0.84; 95% confidence interval, 0.79-0.90), the normal expected range of within-subject variability in TB response on retesting included differences of 6 0.60 IU/ml for all individuals (coefficient of variation, 14%), and 6 0.24 IU/ml (coefficient of variation, 27%) for individuals whose initial TB response was between 0.25 and 0.80 IU/ml. Conclusions: There is substantial variability in TB response when IGRAs are repeated using the same patient sample. IGRA results should be interpreted cautiously when TB response is near interpretation cut-points.Keywords: interferon-g release assay; QuantiFERON; repeatability; imprecision IFN-g release assays (IGRAs) are in vitro immunodiagnostic tests that measure effector T cell-mediated IFN-g response to synthetic Mycobacterium tuberculosis-specific polypeptides. The QuantiFERON-TB Gold In-Tube (QFT-GIT; Cellestis, Carnegie, Australia) is a commercially available IGRA that has been recommended as an alternative to the tuberculin skin test (TST) in targeted screening for M. tuberculosis infection (1).Although IGRAs are widely used in high-income countries and numerous studies have evaluated their diagnostic performance, there are limited data on the precision of IGRA results. Clinically, such data are essential because treatment decisions could be impacted by interpretation of results close to the threshold for a positive test, and for changes above or below this threshold when serial testing is performed (2). Data on test imprecision, including repeatability (serial testing under identical conditions) and reproducibility (serial testing under changed conditions) (3) (see Table 1), are required for CE (Conformité Européene) Marking in the European Union and for premarket approval of in vitro diagnostic tests by the US Food and Drug Administration (FDA) (4).Repeatability is unaffected by inte...

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Discordance among Commercially Available Diagnostics for Latent Tuberculosis Infection

Cited by 53 publications

References 29 publications

Risk Assessment of Tuberculosis in Immunocompromised Patients. A TBNET Study

Risk Assessment of Tuberculosis in Immunocompromised Patients. A TBNET Study

Discordance between Two Interferon-Gamma Release Assays in the Diagnosis of Latent Tuberculosis Infection in Healthcare Workers

Test Variability of the QuantiFERON-TB Gold In-Tube Assay in Clinical Practice

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