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

被引：1

作者：

Barcellos, Regina Bones ^{[1
]}

de Almeida, Isabela Neves ^{[2
]}

da Silva, Elisangela Costa ^{[3
]}

Gomes, Harrison Magdinier ^{[4
]}

de Assis Figueredo, Lida Jouca ^{[2
]}

Halon, Maria Laura ^{[1
]}

Dalla Costa, Elis Regina ^{[1
,5
]}

dos Santos, Icaro Rodrigues ^{[4
]}

Vater, Maria Claudia ^{[3
]}

Alves, Suely ^{[3
]}

Carvalho, Wania da Silva ^{[6
]}

Suffys, Philip ^{[4
]}

Sola, Christophe ^{[7
]}

de Miranda, Silvana Spindola ^{[2
]}

Rossetti, Maria Lucia ^{[1
]}

Kritski, Afranio ^{[3
]}

机构：

[1] Secretaria Estadual Saude Rio Grande Sul SES RS, CDCT, Porto Alegre, RS, Brazil

[2] Univ Fed Minas Gerais, Lab Pesquisa Micobacterias, Fac Med, Belo Horizonte, MG, Brazil

[3] Univ Fed Rio de Janeiro UFRJ, Ctr Pesquisa TB, Fac Med, Rio De Janeiro, RJ, Brazil

[4] Fundacao Oswaldo Cruz FIOCRUZ, Inst Oswaldo Cruz, Lab Biol Mol Aplicada Micobacterias, Rio De Janeiro, RJ, Brazil

[5] AstraZeneca Brasil, Cotia, SP, Brazil

[6] Fac Farm UFMG, Belo Horizonte, MG, Brazil

[7] Univ Paris Saclay, Univ Paris Sud, CNRS, CEA,Inst Integrat Biol Cell I2BC, F-91198 Gif Sur Yvette, France

来源：

BMC INFECTIOUS DISEASES | 2019年 / 19卷 / 01期

关键词：

Tuberculosis; Resistance; TB-SPRINT; Genotype MTBDRplus; Isoniazid; Rifampicin; MULTIDRUG-RESISTANT TUBERCULOSIS; LINE PROBE ASSAY; GENOTYPE MTBDRPLUS; MYCOBACTERIUM-TUBERCULOSIS; PERFORMANCE; MUTATIONS; STRAINS;

D O I：

10.1186/s12879-019-4646-3

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Background: Molecular tests can allow the rapid detection of tuberculosis (TB) and multidrug-resistant TB (MDR-TB). TB-SPRINT 59-Plex Beamedex (R) 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 (TM) MGIT (TM) 960 system and Genotype (R) 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.

引用

页数：8

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