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...

Full description

Bibliographic Details
Main Authors: Anna Starshinova, Viacheslav Zhuravlev, Irina Dovgaluk, Alexandr Panteleev, Vera Manina, Ulia Zinchenko, Evgenia Istomina, Maria Pavlova, Piotr Yablonskiy
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2018-01-01
Series:International Journal of Mycobacteriology
Subjects:
Online Access:http://www.ijmyco.org/article.asp?issn=2212-5531;year=2018;volume=7;issue=1;spage=32;epage=39;aulast=Starshinova
_version_ 1818518851860561920
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.
first_indexed 2024-12-11T01:16:00Z
format Article
id doaj.art-dcde0c41d8c042cb9d8a3c4ad03c02fa
institution Directory Open Access Journal
issn 2212-5531
2212-554X
language English
last_indexed 2024-12-11T01:16:00Z
publishDate 2018-01-01
publisher Wolters Kluwer Medknow Publications
record_format Article
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
work_keys_str_mv AT annastarshinova acomparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT viacheslavzhuravlev acomparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT irinadovgaluk acomparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT alexandrpanteleev acomparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT veramanina acomparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT uliazinchenko acomparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT evgeniaistomina acomparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT mariapavlova acomparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT piotryablonskiy acomparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT annastarshinova comparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT viacheslavzhuravlev comparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT irinadovgaluk comparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT alexandrpanteleev comparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT veramanina comparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT uliazinchenko comparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT evgeniaistomina comparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT mariapavlova comparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection
AT piotryablonskiy comparisonofintradermaltestwithrecombinanttuberculosisallergendiaskintestwithotherimmunologictestsinthediagnosisoftuberculosisinfection