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Accuracy of cobas MTB and MTB-RIF/INH for Detection of Mycobacterium tuberculosis and Drug Resistance.
de Vos, Margaretha; David, Anura; Duraisamy, Karthickeyan; Nadarajan, Darshaalini; Noroc, Ecaterina; Penn-Nicholson, Adam; Crudu, Valeriu; Giri, Sidhartha; Maurer, Florian P; Pati, Sanghamitra; Stevens, Wendy; Scott, Lesley; Turuk, Jyotimayee; Schumacher, Samuel G; Ruhwald, Morten.
Afiliación
  • de Vos M; FIND, Geneva, Switzerland. Electronic address: margaretha.devos@finddx.org.
  • David A; Wits Diagnostic Innovation Hub, Health Sciences Research Unit, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
  • Duraisamy K; FIND, New Delhi, India.
  • Nadarajan D; National and WHO Supranational Reference Center for Mycobacteria, Research Center Borstel, Borstel, Germany.
  • Noroc E; Phtisipneumology Institute "Chiril Draganiuc," Chisinau, Republic of Moldova.
  • Penn-Nicholson A; FIND, Geneva, Switzerland.
  • Crudu V; Phtisipneumology Institute "Chiril Draganiuc," Chisinau, Republic of Moldova.
  • Giri S; Indian Council of Medical Research-Regional Medical Research Centre, Bhubaneswar, India.
  • Maurer FP; National and WHO Supranational Reference Center for Mycobacteria, Research Center Borstel, Borstel, Germany; Institute of Medical Microbiology, Virology and Hospital Hygiene, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Pati S; Indian Council of Medical Research-Regional Medical Research Centre, Bhubaneswar, India.
  • Stevens W; Wits Diagnostic Innovation Hub, Health Sciences Research Unit, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa; The National Priority Program of the National Health Laboratory Service, Johannesburg, South Africa.
  • Scott L; Wits Diagnostic Innovation Hub, Health Sciences Research Unit, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
  • Turuk J; Indian Council of Medical Research-Regional Medical Research Centre, Bhubaneswar, India.
  • Schumacher SG; FIND, Geneva, Switzerland.
  • Ruhwald M; FIND, Geneva, Switzerland.
J Mol Diagn ; 26(8): 708-718, 2024 Aug.
Article en En | MEDLINE | ID: mdl-38851386
ABSTRACT
This study evaluated the performance of cobas MTB and cobas MTB-RIF/INH for the diagnosis of tuberculosis and detection of rifampicin (RIF) and isoniazid (INH) resistance. Adults presenting with pulmonary tuberculosis symptoms were recruited in South Africa, Moldova, and India. Performance of cobas MTB was assessed against culture, whereas cobas MTB-RIF/INH was assessed using phenotypic drug susceptibility testing and whole-genome sequencing as composite reference standards. Xpert MTB/RIF (Xpert) or Xpert MTB/RIF Ultra (Ultra) was used as a comparator. The overall sensitivity and specificity of cobas MTB were 95% (95% CI, 93%-96%) and 96% (95% CI, 95%-97%). Among smear-negatives, the sensitivity of cobas MTB was 75% (95% CI, 66%-83%). Among participants tested with both cobas MTB and Xpert, sensitivity was 96% (95% CI, 94%-97%) for cobas MTB and 95% (95% CI, 93%-97%) for Xpert. Among participants tested with both cobas MTB and Ultra, sensitivity was 88% (95% CI, 81%-92%) for cobas MTB and 89% (95% CI, 83%-93%) for Ultra. Sensitivity and specificity of cobas MTB-RIF/INH for RIF and INH detection were 90% (95% CI, 84%-94%) and 100% (95% CI, 99%-100%), and 89% (95% CI, 84%-93%) and 99.5% (95% CI, 98%-100%), respectively. The cobas MTB and cobas MTB-RIF/INH assays exhibited high performance in a diverse population and present a suitable option for molecular detection of tuberculosis and RIF and INH resistance.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Rifampin / Pruebas de Sensibilidad Microbiana / Sensibilidad y Especificidad / Tuberculosis Resistente a Múltiples Medicamentos / Isoniazida / Mycobacterium tuberculosis Límite: Adult / Female / Humans / Male País/Región como asunto: Africa / Asia / Europa Idioma: En Revista: J Mol Diagn Asunto de la revista: BIOLOGIA MOLECULAR Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Rifampin / Pruebas de Sensibilidad Microbiana / Sensibilidad y Especificidad / Tuberculosis Resistente a Múltiples Medicamentos / Isoniazida / Mycobacterium tuberculosis Límite: Adult / Female / Humans / Male País/Región como asunto: Africa / Asia / Europa Idioma: En Revista: J Mol Diagn Asunto de la revista: BIOLOGIA MOLECULAR Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos