A comparison of intradermal test with recombinant tuberculosis allergen (diaskintest) with other immunologic tests in the diagnosis of tuberculosis infection
Background: The WHO strategy for eradication of tuberculosis (TB) by 2035 (The End TB Strategy) is aimed at an early and precise diagnosis and subsequent effective treatment of TB patients. Currently, there is no gold standard for the diagnosis of latent TB infection. This study evaluated the diagno...
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Wolters Kluwer Medknow Publications
2018-01-01
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Series: | International Journal of Mycobacteriology |
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Online Access: | http://www.ijmyco.org/article.asp?issn=2212-5531;year=2018;volume=7;issue=1;spage=32;epage=39;aulast=Starshinova |
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author | Anna Starshinova Viacheslav Zhuravlev Irina Dovgaluk Alexandr Panteleev Vera Manina Ulia Zinchenko Evgenia Istomina Maria Pavlova Piotr Yablonskiy |
author_facet | Anna Starshinova Viacheslav Zhuravlev Irina Dovgaluk Alexandr Panteleev Vera Manina Ulia Zinchenko Evgenia Istomina Maria Pavlova Piotr Yablonskiy |
author_sort | Anna Starshinova |
collection | DOAJ |
description | Background: The WHO strategy for eradication of tuberculosis (TB) by 2035 (The End TB Strategy) is aimed at an early and precise diagnosis and subsequent effective treatment of TB patients. Currently, there is no gold standard for the diagnosis of latent TB infection. This study evaluated the diagnostic capabilities of a new intradermal test using recombinant TB allergen (Diaskintest) compared with tuberculin skin test (TST) and commercial TB interferon-gamma release assays (IGRAs). Methods: A post-hoc data analysis that involved examining 860 HIV-negative, bacillus Calmette–Guérin (BCG)-vaccinated persons aged 1–65 years who visited the TB health-care institutions of Saint Petersburg to rule out or confirm an active TB was conducted from 2011 to 2016. Results: A high degree of consistency of the Diaskintest results with the enzyme-linked immunospot and QuantiFERON-TB Gold In-Tube test (ELISPOT and QFT) results was observed in the examined pediatric population (n = 696), with a Diaskintest cutoff ≥5 mm: the kappa consistency indices were 1.000 and 0.937, for ELISPOT and QFT, respectively. A high sensitivity of Diaskintest, comparable with the IGRA tests, was observed in patients with a confirmed TB diagnosis in all age groups. The sensitivity of Diaskintest in patients of the TB/MTB + group aged 18 years and older was 88.7%; of ELISPOT, 90.6%; of QFT, 87.0%. The conducted analysis has shown a high concordance of results of the commercial TB tests in adult HIV-negative patients (n = 164) with a Diaskintest cutoff ≥5 mm: the kappa indices were 0.805 and 0.636 (Diaskintest vs. ELISPOT and QFT, respectively) among BCG-vaccinated people. Conclusion: According to the WHO recommendations, replacing the TST by IGRAs is not recommended as a public health intervention in resource-constrained settings because the IGRA tests are more costly and technically complex to conduct than the TST. Diaskintest has comparable complexity to the TST and its performance is close to that of IGRA in a BCG-vaccinated population. Thus, our study demonstrates that replacing the TST by Diaskintest can be recommended as a public health intervention in resource-constrained and universal BCG vaccination settings. |
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format | Article |
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issn | 2212-5531 2212-554X |
language | English |
last_indexed | 2024-12-11T01:16:00Z |
publishDate | 2018-01-01 |
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series | International Journal of Mycobacteriology |
spelling | doaj.art-dcde0c41d8c042cb9d8a3c4ad03c02fa2022-12-22T01:25:54ZengWolters Kluwer Medknow PublicationsInternational Journal of Mycobacteriology2212-55312212-554X2018-01-0171323910.4103/ijmy.ijmy_17_18A comparison of intradermal test with recombinant tuberculosis allergen (diaskintest) with other immunologic tests in the diagnosis of tuberculosis infectionAnna StarshinovaViacheslav ZhuravlevIrina DovgalukAlexandr PanteleevVera ManinaUlia ZinchenkoEvgenia IstominaMaria PavlovaPiotr YablonskiyBackground: The WHO strategy for eradication of tuberculosis (TB) by 2035 (The End TB Strategy) is aimed at an early and precise diagnosis and subsequent effective treatment of TB patients. Currently, there is no gold standard for the diagnosis of latent TB infection. This study evaluated the diagnostic capabilities of a new intradermal test using recombinant TB allergen (Diaskintest) compared with tuberculin skin test (TST) and commercial TB interferon-gamma release assays (IGRAs). Methods: A post-hoc data analysis that involved examining 860 HIV-negative, bacillus Calmette–Guérin (BCG)-vaccinated persons aged 1–65 years who visited the TB health-care institutions of Saint Petersburg to rule out or confirm an active TB was conducted from 2011 to 2016. Results: A high degree of consistency of the Diaskintest results with the enzyme-linked immunospot and QuantiFERON-TB Gold In-Tube test (ELISPOT and QFT) results was observed in the examined pediatric population (n = 696), with a Diaskintest cutoff ≥5 mm: the kappa consistency indices were 1.000 and 0.937, for ELISPOT and QFT, respectively. A high sensitivity of Diaskintest, comparable with the IGRA tests, was observed in patients with a confirmed TB diagnosis in all age groups. The sensitivity of Diaskintest in patients of the TB/MTB + group aged 18 years and older was 88.7%; of ELISPOT, 90.6%; of QFT, 87.0%. The conducted analysis has shown a high concordance of results of the commercial TB tests in adult HIV-negative patients (n = 164) with a Diaskintest cutoff ≥5 mm: the kappa indices were 0.805 and 0.636 (Diaskintest vs. ELISPOT and QFT, respectively) among BCG-vaccinated people. Conclusion: According to the WHO recommendations, replacing the TST by IGRAs is not recommended as a public health intervention in resource-constrained settings because the IGRA tests are more costly and technically complex to conduct than the TST. Diaskintest has comparable complexity to the TST and its performance is close to that of IGRA in a BCG-vaccinated population. Thus, our study demonstrates that replacing the TST by Diaskintest can be recommended as a public health intervention in resource-constrained and universal BCG vaccination settings.http://www.ijmyco.org/article.asp?issn=2212-5531;year=2018;volume=7;issue=1;spage=32;epage=39;aulast=StarshinovaDiagnosis of tuberculosisDiaskintestimmunologic testsinterferon-gamma release assay teststest with recombinant tuberculosis allergen |
spellingShingle | Anna Starshinova Viacheslav Zhuravlev Irina Dovgaluk Alexandr Panteleev Vera Manina Ulia Zinchenko Evgenia Istomina Maria Pavlova Piotr Yablonskiy A comparison of intradermal test with recombinant tuberculosis allergen (diaskintest) with other immunologic tests in the diagnosis of tuberculosis infection International Journal of Mycobacteriology Diagnosis of tuberculosis Diaskintest immunologic tests interferon-gamma release assay tests test with recombinant tuberculosis allergen |
title | A comparison of intradermal test with recombinant tuberculosis allergen (diaskintest) with other immunologic tests in the diagnosis of tuberculosis infection |
title_full | A comparison of intradermal test with recombinant tuberculosis allergen (diaskintest) with other immunologic tests in the diagnosis of tuberculosis infection |
title_fullStr | A comparison of intradermal test with recombinant tuberculosis allergen (diaskintest) with other immunologic tests in the diagnosis of tuberculosis infection |
title_full_unstemmed | A comparison of intradermal test with recombinant tuberculosis allergen (diaskintest) with other immunologic tests in the diagnosis of tuberculosis infection |
title_short | A comparison of intradermal test with recombinant tuberculosis allergen (diaskintest) with other immunologic tests in the diagnosis of tuberculosis infection |
title_sort | comparison of intradermal test with recombinant tuberculosis allergen diaskintest with other immunologic tests in the diagnosis of tuberculosis infection |
topic | Diagnosis of tuberculosis Diaskintest immunologic tests interferon-gamma release assay tests test with recombinant tuberculosis allergen |
url | http://www.ijmyco.org/article.asp?issn=2212-5531;year=2018;volume=7;issue=1;spage=32;epage=39;aulast=Starshinova |
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