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

BMC Infectious Diseases

Regina Bones Barcellos¹  Elis Regina Dalla Costa¹  Maria Laura Halon¹  Maria Lucia Rossetti¹  Suely Alves²  Maria Cláudia Vater²  Afrânio Kritski²  Elisangela Costa da Silva²  Wânia da Silva Carvalho³  Christophe Sola⁴  Harrison Magdinier Gomes⁵  Ícaro Rodrigues dos Santos⁵  Philip Suffys⁵  Silvana Spíndola de Miranda⁶  Isabela Neves de Almeida⁶  Lida Jouca de Assis Figueredo⁶ 

[1] Centro de Desenvolvimento Científico e Tecnológico (CDCT), Secretaria Estadual da Saúde do Rio Grande do Sul (SES/RS);Centro de Pesquisa em Tuberculose, Faculdade de Medicina, Universidade Federal do Rio de Janeiro (UFRJ);Faculdade de Farmácia (UFMG);Institute for Integrative Biology of the Cell (I2BC), CEA, CNRS, Univ. Paris-Sud, Université Paris-Saclay;Laboratório de Biologia Molecular Aplicada a Micobactérias, Instituto Oswaldo Cruz, Fundação Oswaldo Cruz (FIOCRUZ);Laboratório de Pesquisa em Micobactérias, Faculdade de Medicina, Universidade Federal de Minas Gerais (UFMG);

关键词: Tuberculosis;    Resistance;    TB-SPRINT;    Genotype MTBDRplus;    Isoniazid;    Rifampicin;   

DOI  :  10.1186/s12879-019-4646-3

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown