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

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

来源：PLos One, 2014, 9(5): e96367.

DOI：10.1371/journal.pone.0096367

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. %26lt;br%26gt;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. %26lt;br%26gt;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 %26lt; 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%26apos; smear microscopy (SM) status and grade. Combining the results of SM with both ELISA, the detection of ATB patients significantly increased (p %26lt; 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. %26lt;br%26gt;Conclusions: 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.

• 出版日期2014-5-5
• 单位河北医科大学