Results from early programmatic implementation of Xpert MTB/RIF testing in nine countries

Abstract

BackgroundThe Xpert MTB/RIF assay has garnered significant interest as a sensitive and rapid diagnostic tool to improve detection of sensitive and drug resistant tuberculosis. However, most existing literature has described the performance of MTB/RIF testing only in study conditions; little information is available on its use in routine case finding. TB REACH is a multi-country initiative focusing on innovative ways to improve case notification.MethodsWe selected a convenience sample of nine TB REACH projects for inclusion to cover a range of implementers, regions and approaches. Standard quarterly reports and machine data from the first 12 months of MTB/RIF implementation in each project were utilized to analyze patient yields, rifampicin resistance, and failed tests. Data was collected from September 2011 to March 2013. A questionnaire was implemented and semi-structured interviews with project staff were conducted to gather information on user experiences and challenges.ResultsAll projects used MTB/RIF testing for people with suspected TB, as opposed to testing for drug resistance among already diagnosed patients. The projects placed 65 machines (196 modules) in a variety of facilities and employed numerous case-finding strategies and testing algorithms. The projects consumed 47,973 MTB/RIF tests. Of valid tests, 7,195 (16.8%) were positive for MTB. A total of 982 rifampicin resistant results were found (13.6% of positive tests). Of all tests conducted, 10.6% failed. The need for continuous power supply was noted by all projects and most used locally procured solutions. There was considerable heterogeneity in how results were reported and recorded, reflecting the lack of standardized guidance in some countries.ConclusionsThe findings of this study begin to fill the gaps among guidelines, research findings, and real-world implementation of MTB/RIF testing. Testing with Xpert MTB/RIF detected a large number of people with TB that routine services failed to detect. The study demonstrates the versatility and impact of the technology, but also outlines various surmountable barriers to implementation. The study is not representative of all early implementer experiences with MTB/RIF testing but rather provides an overview of the shared issues as well as the many different approaches to programmatic MTB/RIF implementation.

Connectivity of diagnostic technologies: improving surveillance and accelerating tuberculosis elimination

“…Self-contained molecular diagnostic devices have been successfully deployed to detect tuberculosis (TB) (e.g., Xpert w MTB/RIF; Cepheid, Sunnyvale, CA, USA 1 ) or monitor treatment for the human immunodeficiency virus (HIV) (e.g., Alere Pimae CD4, Alere, Waltham, MA, USA 2 ) in very basic clinical facilities. Despite the accumulating evidence that these tools can be successfully used in the most challenging environments 3,4 and the establishment of distribution and funding channels that should theoretically allow any country to access and scale up these new technologies, the majority of patients that could benefit from these technical evolutions still do not have access to them. It is clear that the introduction of an improved TB diagnostic tool is not sufficient to assure improved outcomes for patients, as the details of implementation within existing health delivery systems have a critical influence on impact.…”

Countrywide roll-out of Xpert<SUP>®</SUP> MTB/RIF in Swaziland: the first three years of implementation

“…2,3 Work is ongoing to assess the feasibility, accuracy and effectiveness of Xpert at district and subdistrict health facilities. 4,5 The instrument's functionality in these settings depends on various operational factors, including cost, environmental temperatures, shelf-life of cartridges, electricity supplies, maintenance and the need for annual calibration of the machine. 6 Swaziland is a lower middle-income country with a high burden of TB and HIV.…”

Policy to practice: impact of GeneXpert MTB/RIF implementation on the TB spectrum of care in Lilongwe, Malawi

“…5 While previous research has provided strong evidence of the diagnostic accuracy of the GeneXpert, 4 further information is needed about real-world implementation in resource challenged settings. GeneXpert implementation poses challenges related to both infrastructure requirements for testing [6][7][8] as well as healthcare delivery related factors 9,10 suggesting that expected gains in treatment outcomes may be difficult to achieve. In clinics in South Africa, while more TB cases were confirmed, overall mortality and TB treatment initiation rates did not change after implementation of GeneXpert.…”

“…11 In concordance with the WHO recommendation, Malawi has also adopted GeneXpert testing into national health policy. 4,7,12 The Malawi National TB Control Program (NTP) has endorsed screening hospitalized persons with presumptive TB with GeneXpert. 12 In this setting, the dual burden of HIV and TB, representing 38% 13 and 16% 14 of admission diagnoses, emphasizes the potential importance of the assay in this population.…”