Abstract
BackgroundInadequate tuberculosis (TB) diagnostics, especially for discrimination between active TB (ATB) and latent TB infection (LTBI), are major hurdle in the reduction of the disease burden. The present study aims to investigate the role of lymphocyte non-specific function detection for TB diagnosis in clinical practice.MethodsA total of 208 participants including 49 ATB patients, 64 LTBI individuals, and 95 healthy controls were recruited at Tongji hospital from January 2019 to October 2020. All subjects were tested with lymphocyte non-specific function detection and T-SPOT assay.ResultsSignificantly positive correlation existed between lymphocyte non-specific function and phytohemagglutinin (PHA) spot number. CD4+ T cell non-specific function showed the potential for differentiating patients with negative T-SPOT results from those with positive T-SPOT results with an area under the curve (AUC) of 0.732 (95% CI, 0.572-0.893). The non-specific function of CD4+ T cells, CD8+ T cells, and NK cells was found significantly lower in ATB patients than in LTBI individuals. The AUCs presented by CD4+ T cell non-specific function, CD8+ T cell non-specific function, and NK cell non-specific function for discriminating ATB patients from LTBI individuals were 0.845 (95% CI, 0.767-0.925), 0.770 (95% CI, 0.683-0.857), and 0.691 (95% CI, 0.593-0.789), respectively. Application of multivariable logistic regression resulted in the combination of CD4+ T cell non-specific function, NK cell non-specific function, and culture filtrate protein-10 (CFP-10) spot number as the optimally diagnostic model for differentiating ATB from LTBI. The AUC of the model in distinguishing between ATB and LTBI was 0.939 (95% CI, 0.898-0.981). The sensitivity and specificity were 83.67% (95% CI, 70.96%-91.49%) and 90.63% (95% CI, 81.02%-95.63%) with the threshold as 0.57. Our established model showed superior performance to TB-specific antigen (TBAg)/PHA ratio in stratifying TB infection status.ConclusionsLymphocyte non-specific function detection offers an attractive alternative to facilitate TB diagnosis. The three-index diagnostic model was proved to be a potent tool for the identification of different events involved in TB infection, which is helpful for the treatment and management of patients.
Highlights
Tuberculosis (TB) is a major public issue caused by Mycobacterium tuberculosis (MTB) infection, with around 10 million cases and 1.4 million deaths in 2019 reported by World Health Organization [1]
The TB continues relentlessly, especially during the current global COVID-19 pandemic, killing more than other infection, while the progress being lagging behind other major infectious diseases [34,35,36,37,38]
Our study benchmarked the value of lymphocyte non-specific function in the diagnosis of active TB (ATB) for the first time
Summary
Tuberculosis (TB) is a major public issue caused by Mycobacterium tuberculosis (MTB) infection, with around 10 million cases and 1.4 million deaths in 2019 reported by World Health Organization [1]. The diagnosis of ATB could be achieved by visualization of acidfast bacilli by microscopy, mycobacterial culture, or molecular tests including GeneXpert MTB/RIF. Even in the era of the GeneXpert MTB/RIF Ultra, challenge remains due to unsatisfactory sensitivity for clinical requirement [6, 7], which highlights the fact that better diagnostics might have to be achieved based on host factors rather than pathogen detection. The current use of blood-based available immunological tests including T-SPOT.TB (T-SPOT) and QuantiFERON-TB Gold In-Tube (QFT-GIT) was limited by their poor ability to reliably stratify ATB from LTBI especially in TB endemic areas [8, 9]. Inadequate tuberculosis (TB) diagnostics, especially for discrimination between active TB (ATB) and latent TB infection (LTBI), are major hurdle in the reduction of the disease burden. The present study aims to investigate the role of lymphocyte non-specific function detection for TB diagnosis in clinical practice
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