Comparative performance of QuantiFERON-TB Gold versus skin test with tuberculosis recombinant allergen (Diaskintest) among patients with suspected pulmonary tuberculosis in Russia.

BACKGROUND: The early identification of Mycobacterium tuberculosis infection can prevent tuberculosis (TB) transmission. A skin test with a tuberculosis recombinant allergen (Diaskintest) is a new method for identification that has been implemented in Russia. This study was performed to compare the performances of Diaskintest and QuantiFERON-TB Gold (QFT) in adults and children with suspected TB in Moscow, Russia. METHODS: Adults (n=85) and children (n=96) were tested using Diaskintest and QFT. Concordance and comparative analyses were performed. RESULTS: Diaskintest and QFT were concordant in 84% of adults and 90% of children (overall concordance 87%, κ>0.6, Kc>0.5). The concordance between QFT, Diaskintest, and the final diagnosis was good in adults (86% and 81%, respectively) and moderate in children (77% and 79%, respectively). In adults, QFT had a higher sensitivity for detecting TB than Diaskintest (82% and 68%, respectively); in children, Diaskintest was more sensitive (73% and 65%, respectively). In patients with a confirmed TB diagnosis, negative Diaskintest/QFT results were associated with low disease activity. Combined Diaskintest/QFT results identified TB patients with higher sensitivity and specificity than each test separately. CONCLUSIONS: Diaskintest is a low-cost diagnostic tool that shows a test positivity rate similar to QFT and can be used in combination with QFT as an adjunctive test for TB diagnosis.

Non-invasive approach to diagnosis of pulmonary tuberculosis using microdroplets collected from exhaled air.

In this report we present a proof-of-principle study aimed at developing non-invasive diagnostics for pulmonary TB that are based on analyzing TB biomarkers in exhaled microdroplets of lung fluid (MLFs). Samples were collected on electrospun filters recently developed by the authors, and then tested for the presence of Mycobacterium tuberculosis (Mtb) cells, Mtb DNA, and protein biomarkers (secreted Mtb antigens and antigen-specific antibodies). The latter were detected using rapid ultra-sensitive immunochemistry methods developed in our laboratory. Neither Mtb cells (limit of detection, LOD = 1 cell) nor Mtb DNA (LOD âˆ¼ 10 CFU) were found in the MLF samples exhaled by TB patients. However, immunoglobulin A (IgA) was found in over 90% of samples from TB patients and healthy volunteers. Antigen-specific IgA were detected at higher rates in the patient samples as compared to those from nominally healthy volunteers resulting in a modest discrimination level of 72% sensitivity and 58% specificity. As such, this novel, non-invasive and fast breath diagnostic method shows promise for further development.