| Implementation mechanisms |
Management and technological innovation |
In P1 and Official Letter GAL (2014), it was observed that in July 2014, the directors of the State Central Public Health Laboratories received an official letter from decision-makers with the figure that should be followed for both sample collection and transport. In order to diagnose TB early, access to the information system was optimized by filling out test request forms and returning the results through the GAL. In addition, municipalities received training, events, and technical documents as incentives, but some municipalities were resistant to using the GAL during the RMT-TB implementation period. It should be noted that they were required to fill out two FormSUS forms within the deadline established by the Ministry of Health. |
| Human resources training |
From January to May 2014, document P1 reported that theoretical and practical training was offered to state monitors by the manufacturer of the equipment and cartridges (Cepheid). The monitors were assigned to perform the activities of local laboratory technicians remotely, except in cases of greater complexity. |
| Public funding |
Rel2 reported that the acquisition cost of the machines in the first year of implementation was around R$34,850.00 per machine. The annual calibration cost is R$3,960.00 per machine, according to the manufacturer. The results obtained using a reference value of R$14.16 per smear test showed that both strategies are cost-effective, but Xpert was the dominant strategy. When using R$4.20 as the reference value, the strategies are also cost-effective, with an incremental cost-effectiveness ratio of R$850.00 per TB case detected and R$2,956.00 per case with complete treatment. The acceptability curve showed that for a willingness to pay of R$2,200.00, Xpert is the most cost-effective strategy in 88% of interactions and in 95% for a willingness to pay of R$4,400.00 per detected case. |
| Strategies in implementation |
Time interval (first and second implementation) |
In documents P1 and P2, the first implementation-in March 2014, the Ministry of Health received the equipment, which was distributed in May of the same year, with implementation beginning by monitors the following month. In December 2014, 30 professionals were trained because they were involved in conducting research related to RMT-TB, but the machines were delivered to these teams in April 2015, and the monitors began their work in August of the same year. In document P2, regarding the second implementation, in the maintenance and expansion stage-to expand access to RMT-TB-the Ministry of Health distributed new equipment in 2017 and 2018. |
| Criteria required for RMT-TB implementation |
In document P1, regarding decision-making, it was observed that in the first implementation period (2014-2015), in order to receive the equipment, the municipality had to meet the following criteria: be a capital city or have more than 130 cases of tuberculosis in 2012; be a municipality with a prison unit with a laboratory and high demand for tests; be in a border region and/or have an indigenous population with more than 50 new cases reported in 2011; be a central public health laboratory with high demand for smear microscopy. In document P2, it was noted that in the second implementation period (2017-2018), during the maintenance and expansion of the implementation strategy, the selection of municipalities was carried out according to epidemiological and operational criteria |
| Laboratories selected as regional references |
In P1 and in the LACENS Official Letter (2014), it was noted that at a meeting held in Brasília-DF for decision-making, the laboratories that would act as regional references for the different Brazilian states in performing TB diagnostic tests were defined, and the Adolfo Lutz Institute was the laboratory selected to operate in the state of São Paulo. |
| Municipalities selected to receive equipment and/or support with research |
In P1 and Rel1, it is stated that 21 municipalities in the state of São Paulo were selected to receive the equipment and cartridges, among which Ribeirão Preto, São Paulo, Campinas, and Santo André had proposals selected for research on RMT-TB. |
| Expanding access to RMT-TB for municipalities without the GeneXpert® system (2021-2025) |
Document P2, in the maintenance and expansion stage, addresses that among the objectives proposed by the Ministry of Health is the use of all TB diagnostic methods, including RMT-TB, in strategies to expand access to diagnostic methods nationwide, promoting the expansion of the Rapid TB Testing Network and optimizing flow between municipalities and health regions. |
| Monitoring actions |
Organization plan for RMT-TB monitoring |
In document P1, concurrently with the shipment of equipment to laboratories, a monitoring plan was drawn up with proposals for the flows and instruments necessary to understand the network's production. The objectives are: To know the number of RMT-TB tests performed; To identify the results obtained in performing RMT-TB; To identify errors in RMT-TB equipment. Some activities were prioritized by state and municipal disease control programs, such as reorganizing sample transport flows, decentralizing the GAL, and immediately scheduling appointments for people with rifampicin-resistant TB at the referral unit, among others. |
| Analysis of data from the first year of RMT-TB implementation |
In P1 and B1, it was shown that in 2014, data began to be reported for two municipalities (Santos-SP and Recife-PE). In May 2015, data from other municipalities that received the machine were processed, showing the average RMT-TB performance in relation to the number of devices installed. The highest number of RMT-TB tests performed in Brazil was in the state of SP, with 80,775 tests in the year analyzed, representing 55% of the total tests performed in the country. |
| Actions developed in the second implementation of RMT-TB (2017-2018) |
Document P2 noted that between 2017 and 2020, during the maintenance and expansion phase, in order to advance prevention and integrated care centered on people with TB, several actions were carried out, such as the implementation of new RMT-TB equipment, the implementation of the Xpert MTB/RIF Ultra cartridge, and the updating of recommendations for smear microscopy, culture, and susceptibility testing for the diagnosis of TB. |
Implementation of the Rapid Molecular Test for Tuberculosis in the State of São Paulo: a Documentary Analysis
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