Low Sensitivity of a Whole‐Blood Interferon‐γ Release Assay for Detection of Active Tuberculosis

Abstract

The sensitivity of an interferon-gamma assay (Quantiferon-TB Gold; Cellestis) was evaluated for the detection of tuberculosis among 242 persons with suspected tuberculosis in San Francisco, California. Thirty-seven subjects had culture-confirmed tuberculosis. Excluding 1 indeterminate result, 23 (64%; 95% confidence interval, 48%-78%) of 36 subjects had positive results using the QuantiFERON-TB Gold assay. The 64% sensitivity suggests that the QuantiFERON-TB Gold assay should not be used alone to exclude active tuberculosis.

Laboratory Diagnosis of Extra-pulmonary Tuberculosis (EPTB) in Resource- constrained Setting: State of the Art, Challenges and the Need

“…Negative recommendations were issued by WHO about the use of interferon-γ-release assays for diagnosis of TB or latent M. tuberculosis infection in low-income and middle-income countries. Furthermore, very few studies have evaluated the performance of these assays in EPTB [29,30]. There is also concern about the high rate of inconclusive results in immune-compromised individuals, including HIV positive patients, due to T-cell anergy.…”

Cerebrospinal T-Cell Responses Aid in the Diagnosis of Tuberculous Meningitis in a Human Immunodeficiency Virus– and Tuberculosis-Endemic Population

“…These newer tests enumerate the frequency of peripheral blood effector T cells driven by RD-1 TB-specific antigens (early secreted antigenic target 6 [ESAT-6] and culture filtrate protein 10 [CFP-10]) (15,16). However, this blood-based immunologic approach is unsuitable for the diagnosis of active TB because the test cannot distinguish effector cells in the context of LTBI from cells present during active disease (17)(18)(19)(20)(21). An alternative approach is to quantify the frequency of antigen-specific effector cells at the site of disease rather than in whole blood.…”

Clinical Evaluation of the T-SPOT.TB Test for Patients with Indeterminate Results on the QuantiFERON TB-2G Test

“…Co mp a r i s o n o f Cl i n i c a l , L a b o r a t o r y a n d Ra d i o l o g i c a l F i n d i n g s b e t we e n I n d e t e rmi n a t e P a t i e n t s Gr o u p ( n = 4 0 ) a n d De t e r mi n a t e P a t i e n t s Gr o u p ( n = 3 3 8 ) o f QF T -2 G T e s t T a b l e 2 . Co mp a r i s o n o f Cl i n i c a l , L a b o r a t o r y a n d Ra d i o l o g i c a l F i n d i n g s b e t (2,17,18) (14). In a previous report, Ferrara et al (9) …”