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. 2018 Aug 10;13(8):e0201731.
doi: 10.1371/journal.pone.0201731. eCollection 2018.

The implementation of Xpert MTB/RIF assay for diagnosis of tuberculosis in Nepal: A mixed-methods analysis

Basant Joshi  1 , Trisasi Lestari  2 , Stephen Michael Graham  3   4 , Sushil Chandra Baral  5 , Sharat Chandra Verma  6 , Gokarna Ghimire  6 , Bandana Bhatta  7 , Shyam Prakash Dumre  8 , Adi Utarini  2
Affiliations

The implementation of Xpert MTB/RIF assay for diagnosis of tuberculosis in Nepal: A mixed-methods analysis

Basant Joshi et al. PLoS One. .

Abstract

Background: Tuberculosis (TB) is a major public health problem in low and middle-income countries. Early detection and enrolment of TB cases is a challenge for National TB Programs.

Objective: To understand the performance and feasibility for scale-up of Xpert MTB/RIF assay for the TB diagnosis in Nepal.

Design: Implementation research employed mixed-method sequential explanatory design. The results of Xpert MTB/RIF assay were analysed in 26 TB diagnostic centres where Xpert machines had been installed before 2015. In-depth interviews and focus group discussions were conducted with stakeholders, purposively selected to represent experiences in centres that were functioning well, poorly or not functioning.

Results: During a one-year period in 2015/16, 23,075 Xpert MTB/RIF assays were performed in 21 diagnostic centres with 22,288 people also tested by sputum microscopy. Among these, 77% had concordant (positive or negative) results, demonstrating fair agreement (Kappa score, 0.3) between test results. Test failure and positivity rates in diagnostic centres ranged from 2.6% to 13.4% and 6.5% to 49%, respectively. The number of cartridges per positive result varied from 2.3 to 10.2. Xpert assay was positive in 3314 (15% of all cases) sputum smear microscopy negative cases. Of 4280 bacteriologically confirmed cases by Xpert assay, 355 (8%) were rifampicin resistant. Xpert machines were no longer functioning regularly throughout the year in 5 diagnostic centres. The main barriers for effective implementation of Xpert in Nepal were the lack of: timely supply of cartridges; replacement of damaged modules; maintenance of Xpert machines; and stock verification for timely procurement of cartridges. Inadequate laboratory infrastructure for maintaining functional Xpert equipment further challenges implementation and scale-up.

Conclusion: The implementation of Xpert MTB/RIF assay has increased case-finding of TB and MDR-TB in Nepal. However, there is a need to improve laboratory performance and strengthen laboratory infrastructure for optimal utilisation and scale-up of Xpert.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Districts equipped with Gene Xpert MTB/RIF centres in Nepal by 2015.
Fig 2
Fig 2. Flowchart for selection of centres for quantitative and qualitative data collection.
See this image and copyright information in PMC

References

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