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. 2014 Aug 20;9(8):e105346.
doi: 10.1371/journal.pone.0105346. eCollection 2014.

Enhancing TB case detection: experience in offering upfront Xpert MTB/RIF testing to pediatric presumptive TB and DR TB cases for early rapid diagnosis of drug sensitive and drug resistant TB

Neeraj Raizada  1 , Kuldeep Singh Sachdeva  2 , Sreenivas Achuthan Nair  3 , Shubhangi Kulsange  1 , Radhey Shayam Gupta  2 , Rahul Thakur  1 , Malik Parmar  3 , Christen Gray  4 , Ranjani Ramachandran  3 , Bhavin Vadera  1 , Shobha Ekka  1 , Shikha Dhawan  2 , Ameet Babre  1 , Mayank Ghedia  3 , Umesh Alavadi  1 , Puneet Dewan  3 , Mini Khetrapal  5 , Ashwini Khanna  6 , Catharina Boehme  4 , Chinnambedu Nainarappan Paramsivan  1
Affiliations

Enhancing TB case detection: experience in offering upfront Xpert MTB/RIF testing to pediatric presumptive TB and DR TB cases for early rapid diagnosis of drug sensitive and drug resistant TB

Neeraj Raizada et al. PLoS One. .

Abstract

Background: Diagnosis of pulmonary tuberculosis (PTB) in children is challenging due to difficulties in obtaining good quality sputum specimens as well as the paucibacillary nature of disease. Globally a large proportion of pediatric tuberculosis (TB) cases are diagnosed based only on clinical findings. Xpert MTB/RIF, a highly sensitive and specific rapid tool, offers a promising solution in addressing these challenges. This study presents the results from pediatric groups taking part in a large demonstration study wherein Xpert MTB/RIF testing replaced smear microscopy for all presumptive PTB cases in public health facilities across India.

Methods: The study covered a population of 8.8 million across 18 programmatic sub-district level tuberculosis units (TU), with one Xpert MTB/RIF platform established at each study TU. Pediatric presumptive PTB cases (both TB and Drug Resistant TB (DR-TB)) accessing any public health facilities in study area were prospectively enrolled and tested on Xpert MTB/RIF following a standardized diagnostic algorithm.

Results: 4,600 pediatric presumptive pulmonary TB cases were enrolled. 590 (12.8%, CI 11.8-13.8) pediatric PTB were diagnosed. Overall 10.4% (CI 9.5-11.2) of presumptive PTB cases had positive results by Xpert MTB/RIF, compared with 4.8% (CI 4.2-5.4) who had smear-positive results. Upfront Xpert MTB/RIF testing of presumptive PTB and presumptive DR-TB cases resulted in diagnosis of 79 and 12 rifampicin resistance cases, respectively. Positive predictive value (PPV) for rifampicin resistance detection was high (98%, CI 90.1-99.9), with no statistically significant variation with respect to past history of treatment.

Conclusion: Upfront access to Xpert MTB/RIF testing in pediatric presumptive PTB cases was associated with a two-fold increase in bacteriologically-confirmed PTB, and increased detection of rifampicin-resistant TB cases under routine operational conditions across India. These results suggest that routine Xpert MTB/RIF testing is a promising solution to present-day challenges in the diagnosis of PTB in pediatric patients.

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Conflict of interest statement

Competing Interests: The authors declare that NR, SK, BV, SE, AB, RT, CG, UA, 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 we have partnered have in no way contributed to the study and would not be benefited by the results of the study. As such this does not alter the authors' adherence to PLOS ONE policies on sharing data and materials and there is no conflict of interest to the publication of this article.

Figures

Figure 1
Figure 1. Geographical location of study treatment units and the demographic classification assigned to each project treatment unit site.
Figure 2
Figure 2. Diagnostics Algorithm used under the study.
Figure 3
Figure 3. Flow chart of presumptive pediatric TB cases enrolled in the study.
See this image and copyright information in PMC

References

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