Issa Sabi1, Andrea Rachow2, Daniel Mapamba1, Petra Clowes1, Nyanda E Ntinginya1, Mohamed Sasamalo3, Lujeko Kamwela3, Frederick Haraka4, Michael Hoelscher2, Daniel H Paris5, Elmar Saathoff2, Klaus Reither6. 1. NIMR-Mbeya Medical Research Center, Mbeya, United Republic of Tanzania. 2. Division of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich (LMU), Munich, Germany; German Centre for Infection Research (DZIF), Partner Site Munich, Munich, Germany. 3. Ifakara Health Institute, Bagamoyo, United Republic of Tanzania. 4. Ifakara Health Institute, Bagamoyo, United Republic of Tanzania; Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland. 5. Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland. 6. Ifakara Health Institute, Bagamoyo, United Republic of Tanzania; Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: Klaus.Reither@swisstph.ch.
Abstract
OBJECTIVES: We evaluated the diagnostic performance of the novel next-generation Xpert MTB/RIF Ultra (Xpert Ultra) in comparison to Xpert MTB/RIF (Xpert) assay for the detection of paediatric pulmonary tuberculosis in high burden settings. METHODS: From May 2011 to September 2012, children with suspected pulmonary tuberculosis were enrolled at two Tanzanian sites and sputum samples were examined using sputum smear, Xpert and culture. Xpert Ultra was tested between January and June 2017 using sputum pellets, which had been stored at -80°C. The diagnostic accuracy of Ultra versus Xpert was determined using well-defined case definitions as reference standard. RESULTS: In total, 215 children were included. The median age was 5.4 years, the HIV prevalence was 52% and 13% had culture-confirmed pulmonary tuberculosis. When only the first available sample of each patient was analysed, the sensitivity of Xpert Ultra was 64.3 % (95% CI: 44.1 to 81.4) while that of Xpert was 53.6% (95%CI: 33.9 to 72.5). The specificity of Xpert Ultra based on analysis of all available samples was 98.1% (95%CI: 93.4 to 99.7), that of Xpert was 100%. CONCLUSIONS: Xpert Ultra was found to have a higher sensitivity, but slightly reduced specificity compared to Xpert in detecting pulmonary tuberculosis in children.
OBJECTIVES: We evaluated the diagnostic performance of the novel next-generation Xpert MTB/RIF Ultra (Xpert Ultra) in comparison to Xpert MTB/RIF (Xpert) assay for the detection of paediatric pulmonary tuberculosis in high burden settings. METHODS: From May 2011 to September 2012, children with suspected pulmonary tuberculosis were enrolled at two Tanzanian sites and sputum samples were examined using sputum smear, Xpert and culture. Xpert Ultra was tested between January and June 2017 using sputum pellets, which had been stored at -80°C. The diagnostic accuracy of Ultra versus Xpert was determined using well-defined case definitions as reference standard. RESULTS: In total, 215 children were included. The median age was 5.4 years, the HIV prevalence was 52% and 13% had culture-confirmed pulmonary tuberculosis. When only the first available sample of each patient was analysed, the sensitivity of Xpert Ultra was 64.3 % (95% CI: 44.1 to 81.4) while that of Xpert was 53.6% (95%CI: 33.9 to 72.5). The specificity of Xpert Ultra based on analysis of all available samples was 98.1% (95%CI: 93.4 to 99.7), that of Xpert was 100%. CONCLUSIONS: Xpert Ultra was found to have a higher sensitivity, but slightly reduced specificity compared to Xpert in detecting pulmonary tuberculosis in children.
Authors: Alexander W Kay; Tara Ness; Sabine E Verkuijl; Kerri Viney; Annemieke Brands; Tiziana Masini; Lucia González Fernández; Michael Eisenhut; Anne K Detjen; Anna M Mandalakas; Karen R Steingart; Yemisi Takwoingi Journal: Cochrane Database Syst Rev Date: 2022-09-06
Authors: Christiane M Schmidt; Kathryn L Lovero; Fabiana R Carvalho; Daniele C M Dos Santos; Ana Cláudia M W Barros; Ana Paula Quintanilha; Ana Paula Barbosa; Marcos V S Pone; Sheila M Pone; Julienne Martins Araujo; Camila de Paula Martins; Solange G D Macedo; Ana Lúcia Miceli; Maria Luíza Vieira; Selma M A Sias; Adriano Queiroz; Luis Guillermo Coca Velarde; Afranio L Kritski; Andrea A Silva; Clemax C Sant'Anna; Lee W Riley; Claudete A Araújo Cardoso Journal: Tuberculosis (Edinb) Date: 2019-12-05 Impact factor: 3.131
Authors: Heather J Zar; Lesley J Workman; Margaretha Prins; Linda J Bateman; Slindile P Mbhele; Cynthia B Whitman; Claudia M Denkinger; Mark P Nicol Journal: Am J Respir Crit Care Med Date: 2019-12-15 Impact factor: 21.405
Authors: Alexander W Kay; Lucia González Fernández; Yemisi Takwoingi; Michael Eisenhut; Anne K Detjen; Karen R Steingart; Anna M Mandalakas Journal: Cochrane Database Syst Rev Date: 2020-08-27