03265nas a2200481   4500000000100000008004100001260000900042653001700051653001400068100001500082700001600097700001200113700001600125700001500141700001400156700001200170700001300182700001400195700001200209700001400221700001600235700001400251700001400265700001500279700001100294700001100305700001200316700001600328700001300344700001200357700001200369700001200381700001500393700001300408700001400421245018400435856012100619300001100740490000600751050001700757520199500774022001402769       2014                            d  c201410aTuberculosis10adiagnosis1 aLagrange P1 aThangaraj S1 aDayal R1 aDeshpande A1 aGanguly NK1 aGirardi E1 aJoshi B1 aKatoch K1 aKatoch VM1 aKumar M1 aLakshmi V1 aLeportier M1 aLonguet C1 aMalladi S1 aMukerjee D1 aNair D1 aRaja A1 aRaman B1 aRodrigues C1 aSharma P1 aSingh A1 aSingh S1 aSodha A1 aKabeer BSA1 aVernet G1 aGoletti D00aA 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.  uhttp://www.plosone.org/article/fetchObject.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0096367&representation=PDF  ae963670 v9  aLAGRANGE20143 aBACKGROUND: 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<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.

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.  a1932-6203