Piloting Upfront Xpert MTB/RIF Testing on Various Specimens under Programmatic Conditions for Diagnosis of TB & DR-TB in Paediatric Population

India accounts for one-fifth of the global TB incidence. While the exact burden of childhood TB is not known, TB remains one of the leading causes of childhood mortality in India. Bacteriological confirmation of TB in children is challenging due to difficulty in obtaining quality specimens, in the a...

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Published in:	PloS one Vol. 10; no. 10; p. e0140375
Main Authors:	Raizada, Neeraj, Sachdeva, Kuldeep Singh, Swaminathan, Soumya, Kulsange, Shubhangi, Khaparde, Sunil D, Nair, Sreenivas Achuthan, Khanna, Ashwani, Chopra, Kamal Kishore, Hanif, Mahmud, Sethi, Gulshan Rai, Umadevi, K R, Keshav Chander, G, Saha, Brojakishore, Shah, Amar, Parmar, Malik, Ghediya, Mayank, Jaju, Jyoti, Boehme, Catharina, Paramasivan, Chinnambedu Nainarappan
Format:	Journal Article
Language:	English
Published:	United States Public Library of Science 15-10-2015 Public Library of Science (PLoS)
Subjects:	Adolescent Antibiotics, Antitubercular - pharmacology Body Fluids - microbiology Child Child, Preschool Children Diagnosis Diagnostic systems Diagnostic tests Feasibility studies Female Health care facilities Humans Infant Laboratories Male Mass Screening - methods Medical diagnosis Medical research Microscopy Molecular Diagnostic Techniques - methods Mortality Mycobacterium tuberculosis Mycobacterium tuberculosis - drug effects Mycobacterium tuberculosis - genetics Mycobacterium tuberculosis - isolation & purification National Health Programs Pediatric diseases Pediatrics Polymerase Chain Reaction - methods Precision medicine Reagent Kits, Diagnostic Rifampin Rifampin - pharmacology Sensitivity and Specificity Smear Sputum Systematic review Tuberculosis Tuberculosis, Multidrug-Resistant - diagnosis Tuberculosis, Multidrug-Resistant - microbiology Tuberculosis, Pulmonary - diagnosis Tuberculosis, Pulmonary - microbiology India
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Summary:	India accounts for one-fifth of the global TB incidence. While the exact burden of childhood TB is not known, TB remains one of the leading causes of childhood mortality in India. Bacteriological confirmation of TB in children is challenging due to difficulty in obtaining quality specimens, in the absence of which diagnosis is largely based on clinical judgement. While testing multiple specimens can potentially contribute to higher proportion of laboratory confirmed paediatric TB cases, lack of high sensitivity tests adds to the diagnostic challenge. We describe here our experiences in piloting upfront Xpert MTB/RIF testing, for diagnosis of TB in paediatric population in respiratory and extra pulmonary specimens, as recently recommended by WHO. Xpert MTB/RIF testing was offered to all paediatric (0-14 years) presumptive TB cases (both pulmonary and extra-pulmonary) seeking care at public and private health facilities in the project areas covering 4 cities of India. Under this pilot project, 8,370 paediatric presumptive TB & presumptive DR-TB cases were tested between April and-November 2014. Overall, 9,149 specimens were tested, of which 4,445 (48.6%) were non-sputum specimens. Xpert MTB/RIF gave 9,083 (99.2%, CI 99.0-99.4) valid results. Of the 8,143 presumptive TB cases enrolled, 517 (6.3%, CI 5.8-6.9) were bacteriologically confirmed. TB detection rates were two fold higher with Xpert MTB/RIF as compared to smear microscopy. Further, a total of 60 rifampicin resistant TB cases were detected, of which 38 were detected among 512 presumptive TB cases while 22 were detected amongst 227 presumptive DR-TB cases tested under the project. Xpert MTB/RIF with advantages of quick turnaround testing-time, high proportion of interpretable results and feasibility of rapid rollout, substantially improved the diagnosis of bacteriologically confirmed TB in children, while simultaneously detecting rifampicin resistance.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 Competing Interests: NR, SK, CB and CNP are employed by FIND, a non-profit organization that collaborates with industry partners, including Cepheid Inc., for the development and evaluation of new diagnostic tests. These partners with whom the authors have partnered have in no way contributed to the pilot and would not be benefited by its results. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials. Conceived and designed the experiments: NR KSS SK SDK SAN CNP CB. Performed the experiments: NR SK SS AK KKC MH GRS KRU GKC BKS AS MP MG JJ. Analyzed the data: NR SK. Contributed reagents/materials/analysis tools: NR. Wrote the paper: NR SK SS CNP KSS.
ISSN:	1932-6203 1932-6203
DOI:	10.1371/journal.pone.0140375