title: Piloting Upfront Xpert MTB/RIF Testing on Various Specimens under Programmatic Conditions for Diagnosis of TB & DR-TB in Paediatric Population.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Foundation for Innovative New Diagnostics, New Delhi, India.
authors.forename: Neeraj
authors.initials: N
authors.lastname: Raizada
authors.affiliation: Central TB Division, Government of India, New Delhi, India.
authors.forename: Kuldeep Singh
authors.initials: KS
authors.lastname: Sachdeva
authors.affiliation: National Institute of research in Tuberculosis, Chennai, India.
authors.forename: Soumya
authors.initials: S
authors.lastname: Swaminathan
authors.affiliation: Foundation for Innovative New Diagnostics, New Delhi, India.
authors.forename: Shubhangi
authors.initials: S
authors.lastname: Kulsange
authors.affiliation: Central TB Division, Government of India, New Delhi, India.
authors.forename: Sunil D
authors.initials: SD
authors.lastname: Khaparde
authors.affiliation: World Health Organization, Country Office for India, New Delhi, India.
authors.forename: Sreenivas Achuthan
authors.initials: SA
authors.lastname: Nair
authors.affiliation: New Delhi TB Centre, New Delhi, India.
authors.forename: Ashwani
authors.initials: A
authors.lastname: Khanna
authors.affiliation: New Delhi TB Centre, New Delhi, India.
authors.forename: Kamal Kishore
authors.initials: KK
authors.lastname: Chopra
authors.affiliation: New Delhi TB Centre, New Delhi, India.
authors.forename: Mahmud
authors.initials: M
authors.lastname: Hanif
authors.affiliation: New Delhi TB Centre, New Delhi, India.
authors.forename: Gulshan Rai
authors.initials: GR
authors.lastname: Sethi
authors.affiliation: National Institute of research in Tuberculosis, Chennai, India.
authors.forename: K R
authors.initials: KR
authors.lastname: Umadevi
authors.affiliation: Intermediate Reference Laboratory, Hyderabad, India.
authors.forename: G
authors.initials: G
authors.lastname: Keshav Chander
authors.affiliation: Intermediate Reference Laboratory, Kolkata, India.
authors.forename: Brojakishore
authors.initials: B
authors.lastname: Saha
authors.affiliation: Central TB Division, Government of India, New Delhi, India.
authors.forename: Amar
authors.initials: A
authors.lastname: Shah
authors.affiliation: World Health Organization, Country Office for India, New Delhi, India.
authors.forename: Malik
authors.initials: M
authors.lastname: Parmar
authors.affiliation: Central TB Division, Government of India, New Delhi, India.
authors.forename: Mayank
authors.initials: M
authors.lastname: Ghediya
authors.affiliation: Central TB Division, Government of India, New Delhi, India.
authors.forename: Jyoti
authors.initials: J
authors.lastname: Jaju
authors.affiliation: Foundation for Innovative New Diagnostics, New Delhi, India.
authors.forename: Catharina
authors.initials: C
authors.lastname: Boehme
authors.affiliation: Foundation for Innovative New Diagnostics, New Delhi, India.
authors.forename: Chinnambedu Nainarappan
authors.initials: CN
authors.lastname: Paramasivan
mesh_terms: D000293:Adolescent; D000904:Antibiotics, Antitubercular / Q000494:pharmacology; D001826:Body Fluids / Q000382:microbiology; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008403:Mass Screening / Q000379:methods; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification; D009313:National Health Programs; D016133:Polymerase Chain Reaction / Q000379:methods; D011933:Reagent Kits, Diagnostic; D012293:Rifampin / Q000494:pharmacology; D012680:Sensitivity and Specificity; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000382:microbiology
chemical_list: D000904:Antibiotics, Antitubercular; D011933:Reagent Kits, Diagnostic; D012293:Rifampin