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Wang, Linchuan; Tian, Xu-dong; Yu, Yan; Chen, Wei
Clinica chimica acta, 04/2018, Letnik: 479Journal Article
The IGRA-ELISA and T-SPOT.TB are widely used in China. The aim of the study was to evaluate the performance of the two assays in diagnosis Mycobacterium tuberculosis infection. Of the 3727 patients in the study, 204 underwent testing using both the T-SPOT.TB and IGRA-ELISA, 1794 were tested using the T-SPOT.TB only, and 1729 were tested using the IGRA-ELISA only. The positive rate and consistency of the two assays were analyzed, and their sensitivity and specificity for diagnosing active tuberculosis were compared. There were no significant differences in the positive rate between the T-SPOT.TB test (25.8%) and IGRA-ELISA (28.6%), p = .065. The two assays were highly consistent, with a kappa value of 0.852 (p < .0001) and a total coincidence rate of 92.7%. For the diagnosis of active tuberculosis, the sensitivity and specificity values of the T-SPOT.TB test were 82.9% (107/129) and 78.6% (1309/1665), respectively, and those of IGRA-ELISA were 81.7% (94/115) and 75.2% (1214/1614), respectively. There were no significant differences in sensitivity (p > .05), but the specificity of the T-SPOT.TB test was slightly higher than that of IGRA-ELISA (p = .023). Both in terms of diagnosing M. tuberculosis infection and ruling out active tuberculosis, the performance of the IGRA-ELISA—a simple, almost labor-free assay that allows simultaneous processing of a very large number of samples—was well-matched with that of T-SPOT.TB test. However, IGRAs cannot be used as the only test to diagnose active tuberculosis. •Two IGRAs (T-SPOT.TB test and IGRA-ELISA) were evaluated in the study.•IGRA-ELISA was well-matched with T-SPOT.TB in diagnosing M. tuberculosis infection.•Both T-SPOT.TB test and IGRA-ELISA can be used to rule out active TB.•A cutoff value >300 pg/mL for the IGRA-ELISA or >60 SFCs for T-SPOT.TB test may be reliable to rule in active TB.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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