Evaluation of a new tuberculosis-related interferon gamma release assay for tuberculosis infection diagnosis in Huzhou, eastern China.
OBJECTIVE
To compare the performance of a new tuberculosis-related interferon gamma release assay (TB-IGRA) with that of QuantiFERON-TB Gold In-Tube (QFT-GIT) for TB infection diagnosis in China.


METHODS
A total of 458 active TB patients and 378 healthy individuals were enrolled. Among the 458 active TB patients, 395 had pulmonary TB and 63 had extra-pulmonary TB. The blood samples were collected from the active TB patients and health controls; then TB-IGRA and QFT-GIT were used to detect interferon gamma (IFN-γ) levels.


RESULTS
The sensitivity, specificity, positive predictive value, and negative predictive value in TB infection diagnosis for active TB by the TB-IGRA were 83.4%, 94.2%, 94.5%, and 82.4%, respectively. For QFT-GIT, the sensitivity, specificity, positive predictive value, and negative predictive value in TB infection diagnosis for active TB were 81.4%, 97.1%, 97.1%, and 81.2%, respectively.


CONCLUSIONS
TB-IGRA had a high sensitivity and specificity for TB infection; it could be comparable with the QFT-GIT assay. It might be a powerful assisting tool for TB infection diagnosis in the Chinese clinical setting.
Huzhou Key Laboratory of Molecular Medicine, Huzhou Central Hospital, Huzhou, China.
Fuchu
F
Qian
Weihong
W
Wang
Zhihong
Z
Qiu
Yiqun
Y
Shen
Jiangfang
J
He
Dongli
D
Li
Jing
J
Zhong
Licheng
L
Dai
D000293:Adolescent; D000328:Adult; D000368:Aged; D002681:China; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D006801:Humans; D059425:Interferon-gamma Release Tests / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D014376:Tuberculosis / Q000175:diagnosis*; D055815:Young Adult