Abstract
BackgroundTuberculosis (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.ObjectiveTo understand the performance and feasibility for scale-up of Xpert MTB/RIF assay for the TB diagnosis in Nepal.DesignImplementation 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.ResultsDuring 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.ConclusionThe 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.
Highlights
Tuberculosis (TB) is the major infectious cause of morbidity and mortality in the world [1]
During a one-year period in 2015/16, 23,075 Xpert MTB/RIF assays were performed in 21 diagnostic centres with 22,288 people tested by sputum microscopy
There is a 10% risk of developing TB disease in people infected with TB bacilli, but the risk is higher in young children (
Summary
Tuberculosis (TB) is the major infectious cause of morbidity and mortality in the world [1]. A recent estimate shows that at least one-quarter of the world’s population is infected with Mycobacterium tuberculosis [2]. According to the recent WHO Global TB report, there were 10.4 million TB cases globally and 1.67 million people dying from TB in 2016 [3]. In Nepal, nearly half of the population is infected with M. tuberculosis [5]. According to the Nepal’s National TB Program (NTP) report for 2016 [5], of 32,056 cases registered with NTP in 2015/16, 73% were pulmonary TB (PTB) cases and 75% of these were bacteriologically confirmed. It is estimated that in Nepal each year, approximately 166 per 100,000 population develop TB including 20,000 new sputum smear-positive cases, there are 8,000–10,000 cases not diagnosed, and there are 5,000–7,000 deaths due to TB [5]. Detection and enrolment of TB cases is a challenge for National TB Programs
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