Introducing the ESAT-6 free IGRA, a companion diagnostic for TB vaccines based on ESAT-6
Ruhwald, Morten; de Thurah, Lena; Kuchaka, Davis; Zaher, Mostafa Rafaat; Salman, Ahmed M; Abdel-Ghaffar, Abdel-Rahman; Shoukry, Faten Aly; Michelsen, Sascha Wilk; Soborg, Bolette; Blauenfeldt, Thomas; Mpagama, Stellah; Hoff, Søren T; Agger, Else Marie; Rosenkrands, Ida; Aagard, Claus; Kibiki, Gibson; El-Sheikh, Nabila; Andersen, Peter;
Abstract
There is a need for an improved vaccine for tuberculosis. ESAT-6 is a cardinal vaccine antigen with unique properties and is included in several vaccine candidates in development. ESAT-6 is also the core antigen in the IFN-γ release assays (IGRA) used to diagnose latent infection, rendering IGRA tests unspecific after vaccination. This challenge has prompted the development of a companion diagnostic for ESAT-6 based vaccines, an ESAT-6 free IGRA. We screened a panel of seven potential new diagnostic antigens not recognized in BCG vaccinated individuals. Three highly recognized antigens EspC, EspF and Rv2348c were identified and combined with CFP10 in an ESAT-6 free antigen cocktail. The cocktail was prepared in a field-friendly format, lyophilized with heparin in ready-to-use vacutainer tubes. The diagnostic performance of the ESAT-6 free IGRA was determined in a cross-validation study. Compared IGRA, the ESAT-6 free IGRA induced a comparable magnitude of IFN-γ release, and the diagnostic performance was on par with Quantiferon (sensitivity 84% vs 79%; specificity 99% vs 97%). The comparable performance of the ESAT-6 free IGRA to IGRA suggests potential as companion diagnostic for ESAT-6 containing vaccines and as adjunct test for latent infection.
Other data
| Title | Introducing the ESAT-6 free IGRA, a companion diagnostic for TB vaccines based on ESAT-6 | Authors | Ruhwald, Morten ; de Thurah, Lena ; Kuchaka, Davis ; Zaher, Mostafa Rafaat ; Salman, Ahmed M ; Abdel-Ghaffar, Abdel-Rahman ; Shoukry, Faten Aly ; Michelsen, Sascha Wilk ; Soborg, Bolette ; Blauenfeldt, Thomas ; Mpagama, Stellah ; Hoff, Søren T ; Agger, Else Marie ; Rosenkrands, Ida ; Aagard, Claus ; Kibiki, Gibson ; El-Sheikh, Nabila ; Andersen, Peter | Issue Date | 2017 | Publisher | NATURE PUBLISHING GROUP | Journal | Scientific reports | DOI | 45969 2045-2322 1 https://api.elsevier.com/content/abstract/scopus_id/85017256705 7 10.1038/srep45969 |
PubMed ID | 28387329 | Scopus ID | 2-s2.0-85017256705 | Web of science ID | WOS:000398641700001 |
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