· Fiocruz Pernambuco
Fiocruz Pernambuco has been concentrating efforts on the development of new diagnostic tests for tuberculosis (TB) that are efficient, practical, fast and accessible to the entire population, especially to the most vulnerable groups and to SUS health services. These actions are part of the Study of clinical and laboratory evaluation of rapid, point of care, easy to use and accessible diagnostic testing in regions with high rates of tuberculosis in Brazil and India. The project was one of six in Brazil approved and funded in the Call by the National Council for Scientific and Technological Development CNPq (MS-SCTIE-Decit/CNPq No. 33/2019) for research on tuberculosis in the context of the Brics. Coordinated by Haiana Schindler, its vice-coordination has the researcher Lílian Montenegro, who works in the same department at Fiocruz Pernambuco.
With the first encouraging results obtained with the performance of the two tests, the next step will be the scale production of these technologies (Photo: Barcelona Institute for Global Health/ISGlobal)
Haiana explains that diagnostic testing for TB should preferably be point of care, as it is a highly contagious disease with the potential to rapidly spread if not diagnosed and treated early. Point of care testing add advantages, such as the fact that they are carried out at the patient's point of care, which does not always have to be a health service, allowing for a rapid diagnosis and immediate start of the treatment. They are also simpler and faster, requiring fewer resources than traditional laboratory testing.
The construction of a platform for the evaluation of point of care diagnostic testing, with non-invasive samples (urine and sputum) capable of rapidly detecting the infection, could generate significant savings for the Ministry of Health, since its application would waive with the need for a laboratory structure, and could reach Brazilians who live in more remote regions. It will increase access to early and efficient diagnosis and offer benefits such as easy field execution and simple interpretation of results.
One of the tests for the diagnosis of tuberculosis is being developed in India to be validated in Brazil. “It is a quick, easy test and only needs the urine of the patient with suspected tuberculosis. It works in the same way as a pregnancy test, that is, in a few minutes you get the result with the naked eye”, the scientist celebrates. During his visit to Mumbai (India) in June 2022, at the invitation of the Indian research collaborator Vinay Saini, director of the TUMAAS & Startup Foundation and senior researcher at the Nanobios Laboratory, the prototype was tested and proven to be effective.
In contrast, a team of Brazilian scientists from Fiocruz Pernambuco and the Keizo Asami Institute (Lika/UFPE), coordinated by professors José Luiz de Lima Filho and Emanuel Eusébio de Lima, is developing a biosensor for the diagnosis of tuberculosis that will also be validated in India and Brazil. Preliminary results have already been obtained in a pilot study where the biosensor device demonstrated high sensitivity in detecting DNA extracted from clinical sputum samples from TB patients.
Although the COVID-19 pandemic has hindered or prevented the fulfillment of several stages of the project leading to a considerable delay in its schedule, the prototypes of the biosensor and the rapid urine-based TB testing are practically ready and their evaluation will probably start in August this year, in some states (Pernambuco, Rio de Janeiro, and Minas Gerais) and in the cities of Mumbai, Agra, Sewri and Surat, in India.
With the first encouraging results obtained from the performance of the two tests, the next step will be the full-scale production of these technologies. To this end, partnerships should be established with Brazilian and/or Indian companies to continue the multicenter validation of the tests, in both countries. “At the end of the project's execution, we intend to obtain technological devices validated in Brazil and India, to be used in the early detection of TB, in any location wherever the patient is, with the collection of non-invasive samples (urine, sputum), and which may be incorporated into the SUS and India's public health system and serve as a model for other countries with similar epidemiological and socioeconomic situations”, concludes Haiana.
“Brazil ranks 17th among the 22 countries responsible for 82% of all tuberculosis cases in the world. Although it is a disease that can be prevented, treated and cured, around 4,700 Brazilians die of TB every year”, she recalls. Pernambuco occupies the fourth place in incidence of tuberculosis cases in the country, and Recife is among the capitals that have a higher mortality rate than the country's rate. “It is considered the most worrying state in the Northeast in terms of disease control”, she adds.
The best means of prevention is to make an early diagnosis and start the appropriate treatment as soon as possible. “After 15 days of this treatment, the individual no longer transmits the disease”, informs Haiana. The researcher recalls that tuberculosis is responsible for increasing precarious health, social and economic conditions, especially in developing countries and population groups in situations of greater vulnerability, which include children, indigenous populations, people living with HIV/AIDS, individuals deprived of their freedom and people living on the streets.
Tuberculosis is the second deadliest infectious disease in the world, only behind COVID-19. According to estimates by the World Health Organization (WHO), one third of the world's population is infected by its causative agent, Mycobacterium tuberculosis; therefore, at risk of developing the disease. WHO estimates the number of patients to be ten million, of whom one million die annually.