Setting
In 2016, the Burkina Faso’s TB three-tier laboratory network consisted of a National Reference Laboatory (NRL), 13 regional laboratories and 97 peripheral laboratories. Both fluorescence and conventional light microscopy are the main TB diagnostic method used. In October 2016, three 4-module GeneXpert instruments with Xpert MTB/RIF testing (Cepheid, Sunnyvale CA) became available in the country: one was installed at the NRL, and two in two regional laboratories. Solid culture, phenotypic and genotypic drug suceptibility testing (DST) for first-line anti-TB drugs were only available at the NRL.
Routine TB examination consisted of clinical evaluation, sputum smear microscopy, and chest radiography. Patients at high-risk of multidrug-resistant TB (MDR-TB), children and people living with HIV (PLHIV) were tested for Xpert MTB/RIF and patients with rifampin resistance results were referred to the NRL for phenotypic and genotypic testing for first-line anti-TB drugs.
Intervention Strategy
Under the WHO- Global TB Programme coordination and support, the EBPU-SRL Milan provided extended and highly specialised technical assistance (TA) to the National TB Programme (NTP) and NRL of Burkina Faso. The TA lasted a total of 27 months (October 2016 - December 2018), and focused on two main areas: i) development of strategic documents and policies; ii) implementation of TB diagnostic technology (Fig. 1).
Development of strategic documents and policies
The development of strategic documents and policies has been primarily guided by a comprehensive assessment of the country TB laboratory network together with the conduction of an anti-TB drug-resistance surveillance study (DRS). The National TB Laboratory network assessment led to the identification of strengths and weaknesses of the overall system, whereas the DRS study provided information on national anti-TB drug resistance prevalence. Althogether, these information guided the NTP in the development of targeted public health measures to control the causes and to prevent the further expansion of drug resistant TB. In addition, they allowed to determine priority actions to be implemented, and constituted the foundations for developing new or revising existing national policies and strategic plans such as the five-years National Strategic Plan (NSP) 2018–2022 (REF). Diagnostic algorithms had also been revised to move toward the END TB Strategy goals of universal access to rapid diagnostics and DST [13]. To this purpose, the SRL Milan supported the NTP in the development of an Xpert MTB/RIF operational plan for the years 2018–2022 to strengthen the national GeneXpert network. Special attention had also been paid to the sample referral and transport system to enable the timely diagnosis for patients living in the countries remote areas.
This comprehensive package of strategic and operational plans facilitated the development of the concept note for the Global Fund grant cycle 2018–2020 to ensure the proper financing of the TB laboratory priorities.
Implementation of TB diagnostic technology
The development of strategic documents was interconnected with activities aimed at strengthening the TB national diagnostic services. By the end of 2016, the GeneXpert network was expanded with additional twelve 4-modules machines resulting in a total of 15 instruments covering all regions. A total of 60 laboratory technicians were trained to operate the GeneXpert machines, and more than 200 clinicians were instructed on TB patients referral and initiation of appropriate treatment based on Xpert results. To ensure the effective introduction of Xpert MTB/RIF test within the diagnostic routine, a pilot operational research project financed by the STOP TB Partnership named “Applying a Standardized Approach to Strengthen Performances of GeneXpert Networks” (ASAP-GxNet) was started. In particular, the project aimed at strengthening the local managerial skills and at assessing in a standardised way the functionality of the GeneXpert network. Finally, the expansion of the GeneXpert network accompanied the strengthening of the diagnostic capacity at the NRL. The priorities focused on the implementation of Line Probe Assay (LPA) for second line drugs and on the development of a procurement plan for a Biosafety Level-3 (BSL-3) container laboratory to be used for liquid culture and DST.
Data Sources And Analysis
The National TB Programme provided the TB case notification data from the national TB electronic database from 2016–2018. Data included TB notifications among new and previously treated patients stratified for type of diagnosis (clinical or bacteriological), test type (Xpert MTB/RIF) and result.
Quantitative data per year were imported to Excel spreadsheet and stratified according to five programmatic TB laboratory indicators: i) Percentage of notified new and relapse TB cases with bacteriological confirmation; ii) Percentage of notified new and relapse TB cases tested with a WHO-recommended rapid diagnostic test (WRD); iii) Percentage of notified, bacteriologically confirmed (positive by smear microscopy, culture or WRD) TB cases with DST results for rifampin; iv) Percentage of notified MDR-TB cases; v) Smear/Xpert ratio.
TB notification outcomes were stratified following the five above-mentioned indicators and trends compared over a three years time-frame using a z-test for proportions. A two-tailed p-value less than 0.01 was considered statistically significant.