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. 2015 May 21;10(5):e0126065.
doi: 10.1371/journal.pone.0126065. eCollection 2015.

Use of Xpert MTB/RIF in Decentralized Public Health Settings and Its Effect on Pulmonary TB and DR-TB Case Finding in India

Kuldeep Singh Sachdeva  1 , Neeraj Raizada  2 , Achuthan Sreenivas  3 , Anna H Van't Hoog  4 , Susan van den Hof  5 , Puneet K Dewan  3 , Rahul Thakur  2 , R S Gupta  1 , Shubhangi Kulsange  2 , Bhavin Vadera  2 , Ameet Babre  2 , Christen Gray  2 , Malik Parmar  3 , Mayank Ghedia  1 , Ranjani Ramachandran  3 , Umesh Alavadi  2 , Nimalan Arinaminpathy  6 , Claudia Denkinger  2 , Catharina Boehme  2 , C N Paramasivan  2
Affiliations

Use of Xpert MTB/RIF in Decentralized Public Health Settings and Its Effect on Pulmonary TB and DR-TB Case Finding in India

Kuldeep Singh Sachdeva et al. PLoS One. .

Abstract

Background: Xpert MTB/RIF, the first automated molecular test for tuberculosis, is transforming the diagnostic landscape in high-burden settings. This study assessed the impact of up-front Xpert MTB/RIF testing on detection of pulmonary tuberculosis (PTB) and rifampicin-resistant PTB (DR-TB) cases in India.

Methods: This demonstration study was implemented in 18 sub-district level TB programme units (TUs) in India in diverse geographic and demographic settings covering a population of 8.8 million. A baseline phase in 14 TUs captured programmatic baseline data, and an intervention phase in 18 TUs had Xpert MTB/RIF offered to all presumptive TB patients. We estimated changes in detection of TB and DR-TB, the former using binomial regression models to adjust for clustering and covariates.

Results: In the 14 study TUs, which participated in both phases, 10,675 and 70,556 presumptive TB patients were enrolled in the baseline and intervention phase, respectively, and 1,532 (14.4%) and 14,299 (20.3%) bacteriologically confirmed PTB cases were detected. The implementation of Xpert MTB/RIF was associated with increases in both notification rates of bacteriologically confirmed TB cases (adjusted incidence rate ratio [aIRR] 1.39; CI 1.18-1.64), and proportion of bacteriological confirmed TB cases among presumptive TB cases (adjusted risk ratio (aRR) 1.33; CI 1.6-1.52). Compared with the baseline strategy of selective drug-susceptibility testing only for PTB cases at high risk of drug-resistant TB, Xpert MTB/RIF implementation increased rifampicin resistant TB case detection by over fivefold. Among, 2765 rifampicin resistance cases detected, 1055 were retested with conventional drug susceptibility testing (DST). Positive predictive value (PPV) of rifampicin resistance detected by Xpert MTB/RIF was 94.7% (CI 91.3-98.1), in comparison to conventional DST.

Conclusion: Introduction of Xpert MTB/RIF as initial diagnostic test for TB in public health facilities significantly increased case-notification rates of all bacteriologically confirmed TB by 39% and rifampicin-resistant TB case notification by fivefold.

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Conflict of interest statement

Competing Interests: The authors have read the journal's policy and have the following conflicts: NR, BV, SK, 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. Sreenivas A, Parmar M, Ramchandran R and Dewan P are staff members of WHO. The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions or policies of WHO.

Figures

Fig 1
Fig 1. Geographical location of study treatment units and the demographic classification assigned to each project treatment unit site.
Fig 2
Fig 2. Enrollment of presumptive tuberculosis and drug resistant tuberculosis cases in baseline and intervention period of the study.
See this image and copyright information in PMC

References

    1. World Health Organization, Geneva, Global Tuberculosis Report, 2013; Available: http://apps.who.int/iris/bitstream/10665/91355/1/9789241564656_eng.pdf
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