Multicenter evaluation of TB-SPRINT 59-Plex Beamedex®: accuracy and cost analysis

Autor: Regina Bones Barcellos, Isabela Neves de Almeida, Elisangela Costa da Silva, Harrison Magdinier Gomes, Lida Jouca de Assis Figueredo, Maria Laura Halon, Elis Regina Dalla Costa, Ícaro Rodrigues dos Santos, Maria Cláudia Vater, Suely Alves, Wânia da Silva Carvalho, Philip Suffys, Christophe Sola, Silvana Spíndola de Miranda, Maria Lucia Rossetti, Afrânio Kritski
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: BMC Infectious Diseases, Vol 19, Iss 1, Pp 1-8 (2019)
Druh dokumentu: article
ISSN: 1471-2334
DOI: 10.1186/s12879-019-4646-3
Popis: Abstract Background Molecular tests can allow the rapid detection of tuberculosis (TB) and multidrug-resistant TB (MDR-TB). TB-SPRINT 59-Plex Beamedex® is a microbead-based assay developed for the simultaneous spoligotyping and detection of MDR-TB. The accuracy and cost evaluation of new assays and technologies are of great importance for their routine use in clinics and in research laboratories. The aim of this study was to evaluate the performance of TB-SPRINT at three laboratory research centers in Brazil and calculate its mean cost (MC) and activity-based costing (ABC). Methods TB-SPRINT data were compared with the phenotypic and genotypic profiles obtained using Bactec™ MGIT™ 960 system and Genotype® MTBDRplus, respectively. Results Compared with MGIT, the accuracies of TB-SPRINT for the detection of rifampicin and isoniazid resistance ranged from 81 to 92% and 91.3 to 93.9%, respectively. Compared with MTBDRplus, the accuracies of TB-SPRINT for rifampicin and isoniazid were 99 and 94.2%, respectively. Moreover, the MC and ABC of TB-SPRINT were USD 127.78 and USD 109.94, respectively. Conclusion TB-SPRINT showed good results for isoniazid and rifampicin resistance detection, but still needs improvement to achieve In Vitro Diagnostics standards.
Databáze: Directory of Open Access Journals
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