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Feasibility, Ease-of-Use, and Operational Characteristics of World Health Organization-Recommended Moderate-Complexity Automated Nucleic Acid Amplification Tests for the Detection of Tuberculosis and Resistance to Rifampicin and Isoniazid.
David, Anura; de Vos, Margaretha; Scott, Lesley; da Silva, Pedro; Trollip, Andre; Ruhwald, Morten; Schumacher, Samuel; Stevens, Wendy.
Affiliation
  • David A; Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: anura.david@witshealth.ac.za.
  • de Vos M; FIND, the Global Alliance for Diagnostics, Geneva, Switzerland.
  • Scott L; Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • da Silva P; National Priority Program, National Health Laboratory Services, Johannesburg, South Africa.
  • Trollip A; FIND, the Global Alliance for Diagnostics, Geneva, Switzerland.
  • Ruhwald M; FIND, the Global Alliance for Diagnostics, Geneva, Switzerland.
  • Schumacher S; FIND, the Global Alliance for Diagnostics, Geneva, Switzerland.
  • Stevens W; Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; National Priority Program, National Health Laboratory Services, Johannesburg, South Africa.
J Mol Diagn ; 25(1): 46-56, 2023 01.
Article in En | MEDLINE | ID: mdl-36243289
Four moderate-complexity automated nucleic acid amplification tests for the diagnosis of tuberculosis are reported as having laboratory analytical and clinical performance similar to that of the Cepheid Xpert MTB/RIF assay. These assays are the Abbott RealTime MTB and RealTime MTB RIF/INH Resistance, Becton Dickinson MAX MDR-TB, the Hain Lifescience/Bruker FluoroType MTBDR, and the Roche cobas MTB and MTB RIF/INH assays. The study compared feasibility, ease of use, and operational characteristics of these assays/platforms. Manufacturer input was obtained for technical characteristics. Laboratory operators were requested to complete a questionnaire on the assays' ease of use. A time-in-motion analysis was also undertaken for each platform. For ease-of-use and operational requirements, the BD MAX MDR-TB assay achieved the highest scores (86% and 90%) based on information provided by the user and manufacturer, respectively, followed by the cobas MTB and MTB-RIF/INH assay (68% and 86%), the FluoroType MTBDR assay (67% and 80%), and the Abbott RT-MTB and RT MTB RIF/INH assays (64% and 76%). The time-in-motion analysis revealed that for 94 specimens, the RealTime MTB assay required the longest processing time, followed by the cobas MTB assay and the FluoroType MTBDR assay. The BD MAX MDR-TB assay required 4.6 hours for 22 specimens. These diagnostic assays exhibited different strengths and weaknesses that should be taken into account, in addition to affordability, when considering placement of a new platform.
Subject(s)

Full text: 1 Collection: 01-internacional Health context: 2_ODS3 / 3_ND Database: MEDLINE Main subject: Tuberculosis / Tuberculosis, Pulmonary / Tuberculosis, Multidrug-Resistant / Mycobacterium tuberculosis Type of study: Diagnostic_studies Limits: Humans Language: En Journal: J Mol Diagn Year: 2023 Document type: Article

Full text: 1 Collection: 01-internacional Health context: 2_ODS3 / 3_ND Database: MEDLINE Main subject: Tuberculosis / Tuberculosis, Pulmonary / Tuberculosis, Multidrug-Resistant / Mycobacterium tuberculosis Type of study: Diagnostic_studies Limits: Humans Language: En Journal: J Mol Diagn Year: 2023 Document type: Article