A toolbox for tuberculosis (TB) diagnosis: An Indian multi-centric study (2006-2008); evaluation of serological assays based on PGL-Tb1 and ESAT-6/CFP10 antigens for TB diagnosis

Philippe H. Lagrange, Satheesh K. Thangaraj, Rajeshwar Dayal, Alaka Deshpande, Nirmal K. Ganguly, Enrico Girardi, Beenu Joshi, Kiran Katoch, Vishwa M. Katoch, Manoj Kumar, Vemu Lakshmi, Marc Leportier, Christophe Longuet, Subbalaxmi V S Malladi, Deepali Mukerjee, Deepthi Nair, Alamelu Raja, Balambal Raman, Camilla Rodrigues, Pratibha SharmaAmit Singh, Sarman Singh, Archana Sodha, Basirudeen Syed Ahamed Kabeer, Guy Vernet, Delia Goletti

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Abstract

Background: The aim of this multi-centric prospective study in India was to assess the accuracy of a serological test as an additional tool for diagnosing active tuberculosis (ATB). In particular, an assay based on ELISA using a phenolic glycolipid (PGL-Tb1) or a fusion protein (ESAT-6/CFP10) was compared to the tuberculin skin test (TST) and the microbiological results according to HIV status. Methods: Individuals with and without ATB and HIV infection were enrolled. Serology and TST results were analyzed per se and in combination with the microbiological data. Results: Among the 778 ATB patients, 102 were HIV-infected, 316 HIV-uninfected and 360 had an HIV-unknown status. Of the 945 non-ATB subjects, 559 were at low risk (community adults) and 386 at high risk of M. tuberculosis exposure. Among those with ATB, the sensitivity of ELISA-PGL-Tb1 for ATB was higher than that of ELISA-ESAT-6/CFP10, both in HIV-infected (72.3% versus 63.7%, p = 0.29) and HIV-uninfected/HIV-unknown groups (40.5% versus 28.6%; p

Original languageEnglish
Article numbere96367
JournalPLoS One
Volume9
Issue number5
DOIs
Publication statusPublished - May 5 2014

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

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    Lagrange, P. H., Thangaraj, S. K., Dayal, R., Deshpande, A., Ganguly, N. K., Girardi, E., Joshi, B., Katoch, K., Katoch, V. M., Kumar, M., Lakshmi, V., Leportier, M., Longuet, C., Malladi, S. V. S., Mukerjee, D., Nair, D., Raja, A., Raman, B., Rodrigues, C., ... Goletti, D. (2014). A toolbox for tuberculosis (TB) diagnosis: An Indian multi-centric study (2006-2008); evaluation of serological assays based on PGL-Tb1 and ESAT-6/CFP10 antigens for TB diagnosis. PLoS One, 9(5), [e96367]. https://doi.org/10.1371/journal.pone.0096367