Abstract
BackgroundMolecular 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).MethodsTB-SPRINT data were compared with the phenotypic and genotypic profiles obtained using Bactec™ MGIT™ 960 system and Genotype® MTBDRplus, respectively.ResultsCompared 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.ConclusionTB-SPRINT showed good results for isoniazid and rifampicin resistance detection, but still needs improvement to achieve In Vitro Diagnostics standards.
Highlights
Molecular tests can allow the rapid detection of tuberculosis (TB) and multidrug-resistant TB (MDRTB)
The aim of this study was to evaluate the performance of TB-SPRINT for Multidrug Resistant tuberculosis (MDR-TB) detection at three laboratory research centers in Brazil and to evaluate its mean cost (MC) and activity-based costing (ABC)
At the University of Rio de Janeiro (UFRJ) site, TB-SPRINT showed the following results for RIF: SE of 70%, SP of 100%, Positive predictive value (PPV) of 100%, Negative predictive value (NPV) of 94%, A of 94.7%, and K = 0.794 (p < 0.001)
Summary
Molecular tests can allow the rapid detection of tuberculosis (TB) and multidrug-resistant TB (MDRTB). 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). According to the World Health Organization (WHO), it is estimated that 10 million cases of TB occurred in 2017, causing 1.6 million deaths [1]. Around 558,000 new cases of MDR-TB occurred worldwide in 2017 [1, 2]. In Brazil, about 82,676 TB cases were noted in 2016, out of which 1900 were estimated to be MDR-TB [1].
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