Comparison of a New ESAT-6/CFP-10 Peptide-Based Gamma Interferon Assay and a Tuberculin Skin Test for Tuberculosis Screening in a Moderate-Risk Population

Porsa, Emaeil; Liu, Cheng; Seale, Michael M.; Delclos, George L.; Ma, Xiaojing; Reich, Robert; Musser, James M.; Graviss, Edward A.

doi:10.1128/cvi.13.1.53-58.2006

Cited by 52 publications

(55 citation statements)

References 27 publications

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“…Concordance between RD-1 antigen-based QFT and TST has been reported to be from 53 to 94% in studies of immunocompetent populations screened for LTBI or evaluated in contact investigations (8,(16)(17)(18)(19)(20)(21)(22). This wide range of concordance has been attributed to variation in the amount and type of tuberculin solution used as well as heterogeneity in terms of BCG vaccination, local TB incidence, and estimated time since LTBI infection in the populations studied (21).…”

Section: Discussionmentioning

confidence: 99%

Comparison of an Interferon-γ Release Assay with Tuberculin Skin Testing in HIV-infected Individuals

Luetkemeyer

Charlebois

Flores

et al. 2007

Am J Respir Crit Care Med

179

138

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Section: Discussionmentioning

confidence: 99%

Comparison of an Interferon-γ Release Assay with Tuberculin Skin Testing in HIV-infected Individuals

Luetkemeyer

Charlebois

Flores

et al. 2007

Am J Respir Crit Care Med

179

138

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“…Two technicians from a Clinical Laboratory Improvement Amendments certified (22) laboratory accustomed to IGRA research (23)(24)(25)(26) performed all QFT-GIT assays according to the manufacturer's instructions using identical instrument settings (laboratory testing details are provided in the online supplement). After the initial round of testing, we followed a prospectively formulated retesting algorithm in which QFT-GIT assays were repeated using leftover stimulated plasma from the initial venipuncture.…”

Section: Data Collectionmentioning

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

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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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“…Multiple outbreaks of TB, including those involving the multi-drug-resistant strain (MDR-TB), have been reported in prisons and jails, especially among HIV-infected inmates, a population regarded as having moderate risk of acquiring TB [20]. The results of the current study from this moderate-risk population show that prevalence of LTBI was 24.2% and 56.5% based on the TST and the QFT-G assay respectively.…”

Section: Discussionmentioning

confidence: 66%

“…The codons most frequently involved in RIF mutations were S-531L (57.1%) and codon S-516L (20%). Twenty (20) isolates carried the most common mutation, Ser531 → Leu. As for INH resistance, of the 9 isolates that the Genotype MTBDRplus detected, 78% of them carried mutation at S315T1 codon of the katG gene, showing AGC → ACC mutation, and 22% showed AGC → ACA mutation.…”

Section: Drug Susceptibility Testing (Dst)mentioning

confidence: 99%

Laboratory Diagnosis of Latent and Active Tuberculosis Infections in Trinidad & Tobago and Determination of Drug Susceptibility Profile of Tuberculosis Isolates in the Caribbean

Akpaka¹,

Baboolal²

2012

Understanding Tuberculosis - Global Experiences and Innovative Approaches to the Diagnosis

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Comparison of a New ESAT-6/CFP-10 Peptide-Based Gamma Interferon Assay and a Tuberculin Skin Test for Tuberculosis Screening in a Moderate-Risk Population

Abstract: Screening for latent tuberculosis infection (LTBI) with

Cited by 52 publications

References 27 publications

Comparison of an Interferon-γ Release Assay with Tuberculin Skin Testing in HIV-infected Individuals

Comparison of an Interferon-γ Release Assay with Tuberculin Skin Testing in HIV-infected Individuals

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

Laboratory Diagnosis of Latent and Active Tuberculosis Infections in Trinidad & Tobago and Determination of Drug Susceptibility Profile of Tuberculosis Isolates in the Caribbean

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