Skin Test

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Rafaela Borge Loureiro - One of the best experts on this subject based on the ideXlab platform.

  • cost effectiveness of quantiferon tb gold in tube versus tuberculin Skin Test for diagnosis and treatment of latent tuberculosis infection in primary health care workers in brazil
    PLOS ONE, 2019
    Co-Authors: Renata Lyrio Peres, Rafaela Borge Loureiro, Geisa Fregona, Ethel Leonor Noia Maciel, Rosangela Caetano, Jonathan E Golub, Jose Ueleres Braga
    Abstract:

    Objectives The goal of this study was to perform a cost-effectiveness analysis from the public health system perspective, comparing five strategies for Latent Tuberculosis Infection (LTBI) diagnosis in primary health care workers in Brazil. Design Analytical model for decision making, characterized by cost-effectiveness analysis. Setting Primary Care Level, considering primary health care workers in Brazil. Participants An analytical model for decision making, characterized by a tree of probabilities of events, was developed considering a hypothetical cohort of 10,000 primary health care workers, using the software TreeAge Pro™ 2013 to simulate the clinical and economic impacts of new diagnostic technology (QuantiFERON®-TB Gold in-Tube) versus the traditional tuberculin Skin Test. Methods This model simulated five diagnostic strategies for LTBI in primary health care workers (HCW) in Brazil: tuberculin Skin Testing using ≥5 mm cut-off, tuberculin Skin Testing ≥10 mm cut-off, QuantiFERON®-TB Gold in-Tube, tuberculin Skin Testing using ≥5 mm cut-off confirmed by QuantiFERON®-TB Gold In-Tube if TST positive, tuberculin Skin Testing using ≥10 mm cut-off confirmed by QuantiFERON®-TB Gold In-Tube if TST positive. Primary and secondary outcome measures The outcome measures are the number of individuals correctly classified by the Test and the number of Tuberculosis cases avoided. Results The most cost-effective strategy was the tuberculin Skin Test considering ≥10mm cut-off. The isolated use of the QuantiFERON®-TB Gold In-Tube revealed the strategy of lower efficiency with incremental cost-effectiveness ratio (ICER) of US$ 146.05 for each HCW correctly classified by the Test. Conclusions The tuberculin Skin Test using ≥10 mm cut-off was the most cost-effective strategy in the diagnosis of Latent Tuberculosis Infection in primary health care works in Brazil.

  • comparison of interferon γ release assay to two cut off points of tuberculin Skin Test to detect latent mycobacterium tuberculosis infection in primary health care workers
    PLOS ONE, 2014
    Co-Authors: Fernanda Mattos De Souza, Thiago Nascimento Do Prado, Jair Dos Santos Pinheiro, Renata Lyrio Peres, Thamy Lacerda, Rafaela Borge Loureiro, Jose Americo Carvalho, Geisa Fregona, Elias Dos Santos Dias, Lorrayne Beliqui Cosme
    Abstract:

    Background An interferon-γ release assay, QuantiFERON-TB (QFT) Test, has been introduced an alternative Test for the diagnosis of latent Mycobacterium tuberculosis infection (LTBI). Here, we compared the performance of QFT with tuberculin Skin Test (TST) measured at two different cut-off points among primary health care work (HCW) in Brazil.

Frank Seibold - One of the best experts on this subject based on the ideXlab platform.

Peter Andersen - One of the best experts on this subject based on the ideXlab platform.

  • sensitivity of c tb a novel rd 1 specific Skin Test for the diagnosis of tuberculosis infection
    European Respiratory Journal, 2016
    Co-Authors: Soren T Hoff, Peter Andersen, Pernille N Tingskov, Henrik Aggerbeck, Morten Ruhwald, Jonathan G Peter, Grant Theron, Mellissa Pascoe, Daniel Kolbus, Keertan Dheda
    Abstract:

    C-Tb, a novel Mycobacterium tuberculosis and 6-kDa early secretory antigenic target/10-kDa culture filtrate protein (ESAT-6/CFP-10)-specific Skin Test, has high specificity in bacille Calmette–Guerin-vaccinated healthy controls. However, the sensitivity of C-Tb has hitherto not been determined. The objective was to determine the sensitivity of C-Tb in patients with active tuberculosis (TB) in comparison with the tuberculin Skin Test (TST) and QuantiFERON-TB Gold In-Tube (QFT-GIT). C-Tb and TST were randomly administered in a double-blinded fashion to one or the other forearm in 253 patients with active TB with or without HIV co-infection. QFT-GIT Testing was performed prior to Skin Testing. Using a receiver operating characteristic curve-derived cut-point of 5 mm, C-Tb sensitivity was similar to QFT-GIT (73.9 (95% CI 67.8–79.3) versus 75.1 (95% CI 69.3–80.2)), and similar in HIV-infected and HIV-uninfected patients (76.7 (95% CI 69.0–83.3) versus 69.5 (95% CI 59.2–78.5)). However, sensitivity was significantly diminished in HIV-infected patients with CD4 counts <100 cells·mm–3. C-Tb and QFT-GIT combined had significantly higher sensitivity than C-Tb alone (p<0.0001). C-Tb was safe with no significant adverse events. The 5 mm cut-point corresponded to that found in the previously published specificity study (TESEC-04). C-Tb has similar sensitivity compared with QFT-GIT for the diagnosis of M. tuberculosis infection. Sensitivity was reduced only in HIV-infected patients with severe immunosuppression. Further studies in different settings are required to validate the proposed 5 mm cut-point. C-Tb has similar sensitivity compared with QFT-GIT for the diagnosis of M. tuberculosis infection

  • first in man open clinical trial of a combined rdesat 6 and rcfp 10 tuberculosis specific Skin Test reagent
    PLOS ONE, 2010
    Co-Authors: Winnie Bergstedt, Peter Andersen, Pernille N Tingskov, Birgit Thierrycarstensen, Soren T Hoff, Henrik Aggerbeck, Vibeke Ostergaard Thomsen, Aase B Andersen
    Abstract:

    Background: Tuberculin is still the only available Skin Test reagent for the diagnosis of mycobacterial infection. The product has a remarkable sensitivity, but poor specificity. Previous studies, including two human phase I clinical trials, have indicated that rdESAT-6 has a potential as an improved Skin Test reagent. Animal studies have shown that the sensitivity may be increased by inclusion of the genetically related CFP-10 antigen in the preparation without loosing specificity. Methodology: In this study a Lactococcus fermented, recombinant Skin Test reagent consisting of a 1:1 wt/wt of rdESAT-6 and CFP-10 was manufactured according to GMP standards and Tested for the first time in 42 healthy adult volunteers. The two doses of 0.01 mg or 0.1 mg were injected intradermally by the Mantoux technique with 6 or 12 weeks interval. No serious adverse events and only mild adverse reactions were reported. The reagent elicited a positive Skin Test reaction after the first injection in one participant, who most likely was latently infected with M. tuberculosis as indicated by an appreciable IFN c response just below the QuantiferonH cut-off level at the screening visit. None of the remaining participants in the four groups had any Skin Test reactions and sensitisation by the reagent could therefore be excluded. Conclusion: The investigational Skin Test reagent rdESAT-6 and CFP-10 appeared safe and non-sensitising in this first-in-man clinical trial in human volunteers and can now be Tested in larger clinical trials involving individuals with latent M. tuberculosis infection or active TB disease. Trial Registration: ClinicalTrials.gov NCT00793702

  • double blind randomized phase i study comparing rdesat 6 to tuberculin as Skin Test reagent in the diagnosis of tuberculosis infection
    Tuberculosis, 2008
    Co-Authors: Sandra M Arend, Karin Weldingh, Pernille N Tingskov, Birgit Thierrycarstensen, Henrik Aggerbeck, Willeke P J Franken, Corine Prins, Jaap T Van Dissel, Peter Andersen
    Abstract:

    Summary Limited specificity of the tuberculin Skin Test incited the development of in vitro assays based on Mycobacterium tuberculosis -specific antigens such as ESAT-6 that are lacking in Bacillus Calmette Guerin (BCG). In animal studies, intradermal ESAT-6 was safe and induced specific Skin Test responses. The aim of the study was to assess the safety of intradermal recombinant dimer ESAT-6 (rdESAT-6) compared with tuberculin and to determine the human dose. The study design was a double-blind Phase I study with intra-subject randomization to the left and right forearm, comparing 2 Tuberculin Units (TU) intradermal tuberculin (RT23) with 0.01, 0.1, 1 or 10μg rdESAT-6 in groups of five healthy controls or treated tuberculosis (TB) patients. The risk of sensitization after Skin Testing was assessed in healthy volunteers. All doses were tolerated well by healthy volunteers and responses to rdESAT-6 were limited to transient redness after 24h only at the highest dose. No sensitization was observed. Because 1μg rdESAT-6 induced large responses with local side effects in some TB patients, the 10μg dose of rdESAT-6 was not Tested. Mean responses to 0.01, 0.1 and 1μg rdESAT-6 measured 14.0, 19.8 and 38.8mm of redness, respectively, and 7.0, 13.4 and 14.6mm of induration. The response to tuberculin was similar to the responses to 0.1μg rdESAT-6. Mild local side effects due to tuberculin and rdESAT-6 were observed in 8/15, respectively, 6/15 patients, more pronounced at the highest rdESAT-6 dose. In conclusion, this pilot Phase I study of safety, feasibility and dose finding of intradermal rdESAT-6 provides proof of principle of a specific Skin Test for human use. No serious adverse events were observed but the study was not sufficiently powered to demonstrate complete safety. Intradermal rdESAT-6 did not seem to sensitize healthy volunteers. In treated TB patients, responses to rdESAT-6 were optimal at 0.1μg. Further studies are needed to evaluate sensitization after repeated doses and to study the effect of additional CFP-10 on the sensitivity of a TB-specific Skin Test.

  • comparison of tuberculin Skin Test and new specific blood Test in tuberculosis contacts
    American Journal of Respiratory and Critical Care Medicine, 2004
    Co-Authors: Inger Brock, Karin Weldingh, Troels Lillebaek, Frank Follmann, Peter Andersen
    Abstract:

    The tuberculin Skin Test used to detect latent Mycobacterium tuberculosis infection has many drawbacks, and a new diagnostic Test for latent tuberculosis (QuantiFERON-TB [QTF-TB]) has recently been introduced. This Test measures the production of IFN-γ in whole blood upon stimulation with purified protein derivative (PPD). The QTF-TB Test addresses the operational problems with the tuberculin Skin Test, but, as the Test is based on PPD, it still has a low specificity in populations vaccinated with the Bacile Calmette-Guerin (BCG) vaccine. We have modified the Test to include the antigens ESAT-6 and CFP-10, which are not present in BCG vaccine strains or the vast majority of nontuberculous mycobacteria. This Test was used to detect infection in contacts in a tuberculosis outbreak at a Danish high school. The majority of the contacts were BCG-unvaccinated, which allowed a direct comparison of the Skin Test and the novel blood Test in individuals whose Skin Test was not confounded by vaccination. An excellen...

  • Use of mycobacterial peptides and recombinant proteins for the diagnosis of bovine tuberculosis in Skin Test-positive cattle
    Veterinary Record, 2003
    Co-Authors: Bryce M. Buddle, A. R. Mccarthy, T. J. Ryan, John M. Pollock, H Martin Vordermeier, R. Glyn Hewinson, Peter Andersen, Gw De Lisle
    Abstract:

    More accurate Tests are required to Test cattle which have reacted positively in the tuberculin Skin Test. For this purpose, a range of mycobacterial antigens, MPB59, MPB64, MPB70, MPB83, ESAT-6 and CFP10, were used either as recombinant proteins or as synthetic peptides in the whole blood interferon-γ (IFN-γ) Test. Groups of uninfected cattle with typical ‘non-specificity’ problems were targeted, in particular animals with Skin tuberculosis, animals vaccinated against Johne9s disease and animals that were positive in the standard purified protein derivative (PPD)-based IFN-γ Test. The two study groups consisted of 74 Mycobacterium bovis -culture positive animals and 72 uninfected animals, all of which Tested positive in the caudal fold tuberculin Skin Test eight to 28 days before the blood Test. The use of combinations of ESAT-6 and CFP10 antigens, either as recombinant proteins or peptides, detected similar percentages of M bovis -infected animals as the PPD-based IFN-γ Test, but produced significantly fewer false positive reactions. The PPD-based IFN-γ Test was very effective in differentiating animals vaccinated against Johne9s disease that were Skin-Test positive from those with bovine tuberculosis, and the use of PPD or specific mycobacterial antigens minimised the number of false positive reactions in animals with Skin tuberculosis.

Renata Lyrio Peres - One of the best experts on this subject based on the ideXlab platform.

  • cost effectiveness of quantiferon tb gold in tube versus tuberculin Skin Test for diagnosis and treatment of latent tuberculosis infection in primary health care workers in brazil
    PLOS ONE, 2019
    Co-Authors: Renata Lyrio Peres, Rafaela Borge Loureiro, Geisa Fregona, Ethel Leonor Noia Maciel, Rosangela Caetano, Jonathan E Golub, Jose Ueleres Braga
    Abstract:

    Objectives The goal of this study was to perform a cost-effectiveness analysis from the public health system perspective, comparing five strategies for Latent Tuberculosis Infection (LTBI) diagnosis in primary health care workers in Brazil. Design Analytical model for decision making, characterized by cost-effectiveness analysis. Setting Primary Care Level, considering primary health care workers in Brazil. Participants An analytical model for decision making, characterized by a tree of probabilities of events, was developed considering a hypothetical cohort of 10,000 primary health care workers, using the software TreeAge Pro™ 2013 to simulate the clinical and economic impacts of new diagnostic technology (QuantiFERON®-TB Gold in-Tube) versus the traditional tuberculin Skin Test. Methods This model simulated five diagnostic strategies for LTBI in primary health care workers (HCW) in Brazil: tuberculin Skin Testing using ≥5 mm cut-off, tuberculin Skin Testing ≥10 mm cut-off, QuantiFERON®-TB Gold in-Tube, tuberculin Skin Testing using ≥5 mm cut-off confirmed by QuantiFERON®-TB Gold In-Tube if TST positive, tuberculin Skin Testing using ≥10 mm cut-off confirmed by QuantiFERON®-TB Gold In-Tube if TST positive. Primary and secondary outcome measures The outcome measures are the number of individuals correctly classified by the Test and the number of Tuberculosis cases avoided. Results The most cost-effective strategy was the tuberculin Skin Test considering ≥10mm cut-off. The isolated use of the QuantiFERON®-TB Gold In-Tube revealed the strategy of lower efficiency with incremental cost-effectiveness ratio (ICER) of US$ 146.05 for each HCW correctly classified by the Test. Conclusions The tuberculin Skin Test using ≥10 mm cut-off was the most cost-effective strategy in the diagnosis of Latent Tuberculosis Infection in primary health care works in Brazil.

  • comparison of interferon γ release assay to two cut off points of tuberculin Skin Test to detect latent mycobacterium tuberculosis infection in primary health care workers
    PLOS ONE, 2014
    Co-Authors: Fernanda Mattos De Souza, Thiago Nascimento Do Prado, Jair Dos Santos Pinheiro, Renata Lyrio Peres, Thamy Lacerda, Rafaela Borge Loureiro, Jose Americo Carvalho, Geisa Fregona, Elias Dos Santos Dias, Lorrayne Beliqui Cosme
    Abstract:

    Background An interferon-γ release assay, QuantiFERON-TB (QFT) Test, has been introduced an alternative Test for the diagnosis of latent Mycobacterium tuberculosis infection (LTBI). Here, we compared the performance of QFT with tuberculin Skin Test (TST) measured at two different cut-off points among primary health care work (HCW) in Brazil.

Geisa Fregona - One of the best experts on this subject based on the ideXlab platform.

  • cost effectiveness of quantiferon tb gold in tube versus tuberculin Skin Test for diagnosis and treatment of latent tuberculosis infection in primary health care workers in brazil
    PLOS ONE, 2019
    Co-Authors: Renata Lyrio Peres, Rafaela Borge Loureiro, Geisa Fregona, Ethel Leonor Noia Maciel, Rosangela Caetano, Jonathan E Golub, Jose Ueleres Braga
    Abstract:

    Objectives The goal of this study was to perform a cost-effectiveness analysis from the public health system perspective, comparing five strategies for Latent Tuberculosis Infection (LTBI) diagnosis in primary health care workers in Brazil. Design Analytical model for decision making, characterized by cost-effectiveness analysis. Setting Primary Care Level, considering primary health care workers in Brazil. Participants An analytical model for decision making, characterized by a tree of probabilities of events, was developed considering a hypothetical cohort of 10,000 primary health care workers, using the software TreeAge Pro™ 2013 to simulate the clinical and economic impacts of new diagnostic technology (QuantiFERON®-TB Gold in-Tube) versus the traditional tuberculin Skin Test. Methods This model simulated five diagnostic strategies for LTBI in primary health care workers (HCW) in Brazil: tuberculin Skin Testing using ≥5 mm cut-off, tuberculin Skin Testing ≥10 mm cut-off, QuantiFERON®-TB Gold in-Tube, tuberculin Skin Testing using ≥5 mm cut-off confirmed by QuantiFERON®-TB Gold In-Tube if TST positive, tuberculin Skin Testing using ≥10 mm cut-off confirmed by QuantiFERON®-TB Gold In-Tube if TST positive. Primary and secondary outcome measures The outcome measures are the number of individuals correctly classified by the Test and the number of Tuberculosis cases avoided. Results The most cost-effective strategy was the tuberculin Skin Test considering ≥10mm cut-off. The isolated use of the QuantiFERON®-TB Gold In-Tube revealed the strategy of lower efficiency with incremental cost-effectiveness ratio (ICER) of US$ 146.05 for each HCW correctly classified by the Test. Conclusions The tuberculin Skin Test using ≥10 mm cut-off was the most cost-effective strategy in the diagnosis of Latent Tuberculosis Infection in primary health care works in Brazil.

  • comparison of interferon γ release assay to two cut off points of tuberculin Skin Test to detect latent mycobacterium tuberculosis infection in primary health care workers
    PLOS ONE, 2014
    Co-Authors: Fernanda Mattos De Souza, Thiago Nascimento Do Prado, Jair Dos Santos Pinheiro, Renata Lyrio Peres, Thamy Lacerda, Rafaela Borge Loureiro, Jose Americo Carvalho, Geisa Fregona, Elias Dos Santos Dias, Lorrayne Beliqui Cosme
    Abstract:

    Background An interferon-γ release assay, QuantiFERON-TB (QFT) Test, has been introduced an alternative Test for the diagnosis of latent Mycobacterium tuberculosis infection (LTBI). Here, we compared the performance of QFT with tuberculin Skin Test (TST) measured at two different cut-off points among primary health care work (HCW) in Brazil.