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.
<h4>Background</h4>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 (E...
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Public Library of Science (PLoS)
2014-01-01
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| author | 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 Sharma Amit Singh Sarman Singh Archana Sodha Basirudeen Syed Ahamed Kabeer Guy Vernet Delia Goletti |
| author_facet | 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 Sharma Amit Singh Sarman Singh Archana Sodha Basirudeen Syed Ahamed Kabeer Guy Vernet Delia Goletti |
| author_sort | Philippe H Lagrange |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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<0.0001), whereas the specificity was around 91% for both tests. Sensitivity for ATB increased when the results of the two ELISA were combined, reaching 75.5% in the HIV-infected and 50.9% in the group of HIV-uninfected/HIV-unknown ATB, with a significant decrease of the global specificity (83.9%). Analyzing the ELISA results with the microbiological results, we observed that the sensitivity of both serology tests was independent of the ATB patients' smear microscopy (SM) status and grade. Combining the results of SM with both ELISA, the detection of ATB patients significantly increased (p<0.0001), particularly in those with extrapulmonary TB (up to 45.1%) or HIV infection (up to 83.3%). No significant association was observed between TST and serology results.<h4>Conclusions</h4>In this prospective multi-centric study, the combination of two rapid tests, such as SM and serology, might be useful in detecting ATB, especially in HIV-infected patients. |
| format | Article |
| id | doaj-art-342ec1a5cf8146b899f5aa1ce0ab466e |
| institution | DOAJ |
| issn | 1932-6203 |
| language | English |
| publishDate | 2014-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-342ec1a5cf8146b899f5aa1ce0ab466e2025-08-20T03:00:27ZengPublic Library of Science (PLoS)PLoS ONE1932-62032014-01-0195e9636710.1371/journal.pone.0096367A 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 LagrangeSatheesh K ThangarajRajeshwar DayalAlaka DeshpandeNirmal K GangulyEnrico GirardiBeenu JoshiKiran KatochVishwa M KatochManoj KumarVemu LakshmiMarc LeportierChristophe LonguetSubbalaxmi V S MalladiDeepali MukerjeeDeepthi NairAlamelu RajaBalambal RamanCamilla RodriguesPratibha SharmaAmit SinghSarman SinghArchana SodhaBasirudeen Syed Ahamed KabeerGuy VernetDelia Goletti<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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<0.0001), whereas the specificity was around 91% for both tests. Sensitivity for ATB increased when the results of the two ELISA were combined, reaching 75.5% in the HIV-infected and 50.9% in the group of HIV-uninfected/HIV-unknown ATB, with a significant decrease of the global specificity (83.9%). Analyzing the ELISA results with the microbiological results, we observed that the sensitivity of both serology tests was independent of the ATB patients' smear microscopy (SM) status and grade. Combining the results of SM with both ELISA, the detection of ATB patients significantly increased (p<0.0001), particularly in those with extrapulmonary TB (up to 45.1%) or HIV infection (up to 83.3%). No significant association was observed between TST and serology results.<h4>Conclusions</h4>In this prospective multi-centric study, the combination of two rapid tests, such as SM and serology, might be useful in detecting ATB, especially in HIV-infected patients.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0096367&type=printable |
| spellingShingle | 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 Sharma Amit Singh Sarman Singh Archana Sodha Basirudeen Syed Ahamed Kabeer Guy Vernet Delia Goletti 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 |
| title | 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. |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | 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. |
| title_sort | 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 |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0096367&type=printable |
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