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Pluslife MTBC Card: a new rapid diagnostic tool for management of pulmunary TB patients

C M Crovara Pesce(1,2) F Bisognin(2) V Ferraro(1,2) F Sorella(1) P Dal Monte(1,2)

1:Microbiology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy; 2:Alma Mater Studiorum University of Bologna, Italy

The new MTBC Card (Pluslife, China) is a molecular test for a rapid Tuberculosis (TB) diagnosis, with results available in 30 minutes. The aim of this study is to evaluate the performance of Pluslife MTBC Card on selected Xpert® MTB/RIF Ultra (Cepheid, USA) positive sputum samples. Thirty Xpert® MTB/RIF Ultra (Ultra) positive sputum sediments, previously treated according to the standard guidelines for mycobacteria detection and stored at -20 °C, were included in the study. All thawed specimens have been processed both with Ultra and Pluslife MTBC Card (MTBC-Card) following manufacturers' IFUs. 30 sputum sediment were re-tested by Ultra, with the following semi-quantitative load: High (n=5), Medium (n=5) Low (n=10) and very low (n=10).  All samples resulted High and Medium by Ultra were confirmed positive by MTBC-Card with a range time of detection of 12-17 minutes. 9 of 10 (90%) samples with Low result by Ultra were also MTBC-Card positive with a time of detection range of 15-27 minutes. Among Ultra samples with a Very low load, 3 (30%) were confirmed positive by MTBC-Card with a time of detection range of 21-28 minutes. These preliminary results showed a full agreement between Ultra and MTBC-Card in smear-positive specimens with significant time savings, whereas MTBC-Card resulted positive in 60% of smear-negative specimens. In conclusion, this new device appears to be effective in early diagnosis of TB cases, allowing early patient isolation.

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