Rapid diagnosis of pulmonary tuberculosis in African children in a primary care setting by use of Xpert MTB/RIF on respiratory specimens: a prospective study

Background: In children admitted to hospital, rapid, accurate diagnosis of pulmonary tuberculosis with the Xpert MTB/RIF assay is possible, but no paediatric studies have been done in the primary care setting, where most children are given care, and where microbiological diagnosis is rarely availabl...

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Main Authors: Prof Heather J Zar, PhD, Lesley Workman, MPH, Washiefa Isaacs, MSc, Prof Keertan Dheda, PhD, Widaad Zemanay, PhD, Prof Mark P Nicol, PhD
Format: Article
Language:English
Published: Elsevier 2013-08-01
Series:The Lancet Global Health
Online Access:http://www.sciencedirect.com/science/article/pii/S2214109X13700366
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author Prof Heather J Zar, PhD
Lesley Workman, MPH
Washiefa Isaacs, MSc
Prof Keertan Dheda, PhD
Widaad Zemanay, PhD
Prof Mark P Nicol, PhD
author_facet Prof Heather J Zar, PhD
Lesley Workman, MPH
Washiefa Isaacs, MSc
Prof Keertan Dheda, PhD
Widaad Zemanay, PhD
Prof Mark P Nicol, PhD
author_sort Prof Heather J Zar, PhD
collection DOAJ
description Background: In children admitted to hospital, rapid, accurate diagnosis of pulmonary tuberculosis with the Xpert MTB/RIF assay is possible, but no paediatric studies have been done in the primary care setting, where most children are given care, and where microbiological diagnosis is rarely available. We assessed the diagnostic accuracy of Xpert MTB/RIF in children in primary care. Methods: For this prospective study, we obtained repeat induced sputum and nasopharyngeal aspirate specimens from children (<15 years) with suspected pulmonary tuberculosis at a clinic in Khayeliwtsha, Cape Town, South Africa. We compared the diagnostic accuracy of Xpert MTB/RIF with a reference standard of culture and smear microscopy on induced sputum specimens. For the main analysis, specificity of Xpert MTB/RIF versus liquid culture, we included only children with two interpretable Xpert MTB/RIF and induced sputum culture results. Findings: Between Aug 1, 2010, and July 30, 2012, we enrolled 384 children (median age 38·3 months, IQR 21·2–56·5) who had one paired induced sputum and nasopharyngeal specimen, 309 (81%) of whom had two paired specimens. Five children (1%) tested positive for tuberculosis by smear microscopy, 26 (7%) tested positive by Xpert MTB/RIF, and 30 (8%) tested positive by culture. Xpert MTB/RIF on two induced sputum specimens detected 16 of 28 culture-confirmed cases (sensitivity of 57·1%, 95% CI 39·1–73·5) and on two nasopharyngeal aspirates detected 11 of 28 culture-confirmed cases (sensitivity of 39·3, 23·6–57·6; p=0·18). The specificity of Xpert MTB/RIF on induced sputum was 98·9% (95% CI 96·9–99·6) and on nasopharyngeal aspirates was 99·3% (97·4–99·8). Interpretation: Our findings suggest that Xpert MTB/RIF on respiratory secretions is a useful test for rapid diagnosis of paediatric pulmonary tuberculosis in primary care. Funding: National Institutes of Health, National Health Laboratory Services Research Trust, the Medical Research Council of South Africa, the National Research Foundation South Africa, the European and Developing Countries Clinical Trials Partnership.
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spelling doaj.art-11a615b68ea843c2b4861d1fef2ab4862022-12-21T21:43:09ZengElsevierThe Lancet Global Health2214-109X2013-08-0112e97e10410.1016/S2214-109X(13)70036-6Rapid diagnosis of pulmonary tuberculosis in African children in a primary care setting by use of Xpert MTB/RIF on respiratory specimens: a prospective studyProf Heather J Zar, PhD0Lesley Workman, MPH1Washiefa Isaacs, MSc2Prof Keertan Dheda, PhD3Widaad Zemanay, PhD4Prof Mark P Nicol, PhD5Department of Paediatrics and Child Health, University of Cape Town, Cape Town, South AfricaDepartment of Paediatrics and Child Health, University of Cape Town, Cape Town, South AfricaDepartment of Paediatrics and Child Health, University of Cape Town, Cape Town, South AfricaDepartment of Medicine, University of Cape Town, Cape Town, South AfricaDivision of Medical Microbiology, Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South AfricaDivision of Medical Microbiology, Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South AfricaBackground: In children admitted to hospital, rapid, accurate diagnosis of pulmonary tuberculosis with the Xpert MTB/RIF assay is possible, but no paediatric studies have been done in the primary care setting, where most children are given care, and where microbiological diagnosis is rarely available. We assessed the diagnostic accuracy of Xpert MTB/RIF in children in primary care. Methods: For this prospective study, we obtained repeat induced sputum and nasopharyngeal aspirate specimens from children (<15 years) with suspected pulmonary tuberculosis at a clinic in Khayeliwtsha, Cape Town, South Africa. We compared the diagnostic accuracy of Xpert MTB/RIF with a reference standard of culture and smear microscopy on induced sputum specimens. For the main analysis, specificity of Xpert MTB/RIF versus liquid culture, we included only children with two interpretable Xpert MTB/RIF and induced sputum culture results. Findings: Between Aug 1, 2010, and July 30, 2012, we enrolled 384 children (median age 38·3 months, IQR 21·2–56·5) who had one paired induced sputum and nasopharyngeal specimen, 309 (81%) of whom had two paired specimens. Five children (1%) tested positive for tuberculosis by smear microscopy, 26 (7%) tested positive by Xpert MTB/RIF, and 30 (8%) tested positive by culture. Xpert MTB/RIF on two induced sputum specimens detected 16 of 28 culture-confirmed cases (sensitivity of 57·1%, 95% CI 39·1–73·5) and on two nasopharyngeal aspirates detected 11 of 28 culture-confirmed cases (sensitivity of 39·3, 23·6–57·6; p=0·18). The specificity of Xpert MTB/RIF on induced sputum was 98·9% (95% CI 96·9–99·6) and on nasopharyngeal aspirates was 99·3% (97·4–99·8). Interpretation: Our findings suggest that Xpert MTB/RIF on respiratory secretions is a useful test for rapid diagnosis of paediatric pulmonary tuberculosis in primary care. Funding: National Institutes of Health, National Health Laboratory Services Research Trust, the Medical Research Council of South Africa, the National Research Foundation South Africa, the European and Developing Countries Clinical Trials Partnership.http://www.sciencedirect.com/science/article/pii/S2214109X13700366
spellingShingle Prof Heather J Zar, PhD
Lesley Workman, MPH
Washiefa Isaacs, MSc
Prof Keertan Dheda, PhD
Widaad Zemanay, PhD
Prof Mark P Nicol, PhD
Rapid diagnosis of pulmonary tuberculosis in African children in a primary care setting by use of Xpert MTB/RIF on respiratory specimens: a prospective study
The Lancet Global Health
title Rapid diagnosis of pulmonary tuberculosis in African children in a primary care setting by use of Xpert MTB/RIF on respiratory specimens: a prospective study
title_full Rapid diagnosis of pulmonary tuberculosis in African children in a primary care setting by use of Xpert MTB/RIF on respiratory specimens: a prospective study
title_fullStr Rapid diagnosis of pulmonary tuberculosis in African children in a primary care setting by use of Xpert MTB/RIF on respiratory specimens: a prospective study
title_full_unstemmed Rapid diagnosis of pulmonary tuberculosis in African children in a primary care setting by use of Xpert MTB/RIF on respiratory specimens: a prospective study
title_short Rapid diagnosis of pulmonary tuberculosis in African children in a primary care setting by use of Xpert MTB/RIF on respiratory specimens: a prospective study
title_sort rapid diagnosis of pulmonary tuberculosis in african children in a primary care setting by use of xpert mtb rif on respiratory specimens a prospective study
url http://www.sciencedirect.com/science/article/pii/S2214109X13700366
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