Upfront Xpert MTB/RIF for diagnosis of pediatric TB-Does it work? Experience from India.

Amit Kalra ,Soumya Swaminathan,Shalini Mall,Ashwani Khanna,N Vasundhara,K R Umadevi,Neeraj Raizada,Abdul Azeem,Varinder Singh,Catharina Boehme,Debadutta Parija,Raghuram Rao,Sreenivas Achuthan Nair,Claudia M Denkinger,Rajashree Sen,Sanjay Sarin,Jyoti Khurana,Vijay Chhajlani,K N Sheladia,Rama Rao ,Neeladrisingha Das ,Mahmud Hanif ,A R Nirmala ,Anil Singarajipura ,K.k Chopra ,Bandana Choudhury ,Sarabjit Chadha ,Kuldeep Singh Sachdeva

doi:10.1371/journal.pone.0236057

Abstract

BackgroundDiagnosis of TB in pediatric population poses several challenges. A novel initiative was implemented in several major cities of India aimed at providing upfront access to free-of-cost Xpert MTB/RIF to presumptive pediatric TB cases. This paper aims to describe the experience of implementing this large initiative and assess feasibility of the intervention in high TB burden settings.MethodsData were drawn from the pediatric TB project implemented in 10 major cities of India between April 2014 and March 2018. In each city, providers, both public and private, were engaged and linked with a high throughput Xpert MTB/RIF lab (established in that city) through rapid specimen transportation and electronic reporting system. Rates and proportions were estimated to describe the characteristics of this cohort.ResultsOf the total 94,415 presumptive pediatric TB cases tested in the project, 6,270 were diagnosed positive for MTB (6.6%) on Xpert MTB/RIF (vs 2% on smear microscopy). Among MTB positives, 545 cases were rifampicin resistant (8.7%). The median duration between collection of specimens and reporting of results was 0 days (same day) and >89% cases were initiated on treatment. Approximately 50% of the specimens tested were non-sputum. The number of providers/facilities engaged under the project increased >10-fold (from 124 in Q2’14 to 1416 in Q1’18).ConclusionThis project, which was one of the largest initiatives globally among pediatric population, demonstrated the feasibility of sustaining rapid and upfront access to free-of-cost Xpert MTB/RIF testing. The project underscores the efficiency of this rapid diagnostic assay in tackling several challenges in pediatric TB diagnosis, identifies opportunities for further interventions as well as brings to light scope for effective engagement with healthcare providers. The findings have facilitated a policy decision by National TB Programme mandating the use of Xpert MTB/RIF as a primary diagnostic tool for TB diagnosis in children, which is being scaled-up.

Highlights

Tuberculosis (TB) continues to be a major public health concern especially in high-burden countries like India which accounts for approximately 28% of the 10 million global incident TB cases annually [1]
Of the total 94,415 presumptive pediatric TB cases tested in the project, 6,270 were diagnosed positive for MTB (6.6%) on Xpert MTB/RIF
To address the gaps associated with diagnostics in pediatric TB care cascade, World Health Organization (WHO) recommends the use of a rapid diagnostic test, Xpert MTB/RIF (Cepheid Inc, Sunnyvale, CA, USA) as the initial diagnostic test in children suspected of having TB/ rifampicin resistant (RR) TB [11]

Summary

Introduction

Tuberculosis (TB) continues to be a major public health concern especially in high-burden countries like India which accounts for approximately 28% of the 10 million global incident TB cases annually [1]. Many children are unable to expectorate sputum adequately, and relative to adults, the likelihood of paucibacillary, smear-negative and extrapulmonary TB are high among this vulnerable population [6,7,8] These challenges significantly decrease the feasibility of prompt detection of TB as well as drug resistance in children [9]. Once initiated on treatment, children have a better prognosis relative to adults [10] Together, these strengthen the importance of orienting and engaging health care providers (public and private) to suspect and test the symptomatic pediatric cases for TB. To address the gaps associated with diagnostics in pediatric TB care cascade, World Health Organization (WHO) recommends the use of a rapid diagnostic test, Xpert MTB/RIF (Cepheid Inc, Sunnyvale, CA, USA) as the initial diagnostic test in children suspected of having TB/ RR TB [11]. This paper aims to describe the experience of implementing this large initiative and assess feasibility of the intervention in high TB burden settings

Objectives

Results

Conclusion