Performance of T-Track® TB, a Novel Dual Marker RT-qPCR-Based Whole-Blood Test for Improved Detection of Active Tuberculosis

Abstract

Tuberculosis (TB) is one of the leading causes of death by an infectious disease. It remains a major health burden worldwide, in part due to misdiagnosis. Therefore, improved diagnostic tests allowing the faster and more reliable diagnosis of patients with active TB are urgently needed. This prospective study examined the performance of the new molecular whole-blood test T-Track® TB, which relies on the combined evaluation of IFNG and CXCL10 mRNA levels, and compared it to that of the QuantiFERON®-TB Gold Plus (QFT-Plus) enzyme-linked immunosorbent assay (ELISA). Diagnostic accuracy and agreement analyses were conducted on the whole blood of 181 active TB patients and 163 non-TB controls. T-Track® TB presented sensitivity of 94.9% and specificity of 93.8% for the detection of active TB vs. non-TB controls. In comparison, the QFT-Plus ELISA showed sensitivity of 84.3%. The sensitivity of T-Track® TB was significantly higher (p < 0.001) than that of QFT-Plus. The overall agreement of T-Track® TB with QFT-Plus to diagnose active TB was 87.9%. Out of 21 samples with discordant results, 19 were correctly classified by T-Track® TB while misclassified by QFT-Plus (T-Track® TB-positive/QFT-Plus-negative), and two samples were misclassified by T-Track® TB while correctly classified by QFT-Plus (T-Track® TB-negative/QFT-Plus-positive). Our results demonstrate the excellent performance of the T-Track® TB molecular assay and its suitability to accurately detect TB infection and discriminate active TB patients from non-infected controls.

From immunology to artificial intelligence: revolutionizing latent tuberculosis infection diagnosis with machine learning

“…T-Track ® TB includes a negative control tube (Nil), a positive control tube (Mitogen), and a TB antigen tube with the TB antigen being a recombinant ESAT-6/CFP-10 heterodimer protein produced by BL21 (DE3) Escherichia coli . A recent case–control study compared the performance of T-Track ® TB and QFT-Plus in diagnosing ATB [ 209 ]. The study included a total of 541 subjects (including 273 ATB patients and 268 uninfected controls) and tested them according to the respective instructions.…”

“…The sensitivity of T-Track ® TB was significantly higher than that of QFT-Plus ( P < 0.001). The overall consistency between the two test methods for detecting ATB was 87.9% [ 209 ]. It should be noted that this study has limited research on the ability to distinguish LTBI from ATB, and more research is needed to verify its accuracy.…”