A new diagnostic test developed by researchers at the Oswaldo Cruz Foundation (Fiocruz) can contribute to coping with leprosy. Based on the PCR methodology, the NAT Leprosy Kit was registered at the National Health Surveillance Agency (Anvisa). The exam detects the DNA of the Mycobacterium leprae bacillus, which causes the disease, and can facilitate the early detection of the disease, which affects, on average, 27 people per year in Brazil.
The innovation was developed by the Oswaldo Cruz Institute (IOC/Fiocruz) in partnership with the Carlos Chagas Institute (Fiocruz-PR) and the Institute of Molecular Biology of Paraná (IBMP), linked to Fiocruz and the government of Paraná. The researchers underscore the importance of applying cutting-edge methodology against a neglected disease.
“Until then, there were no diagnostic tests for leprosy that were considered the gold standard. It is a milestone to make this test available to vulnerable populations, who are the ones who most develop the disease and need technological advances”, says the project leader and head of the Leprosy Laboratory of the IOC, Milton Ozório Moraes.
National creation: after decades of research by the Fiocruz, Brazil wins the country's first molecular test for the diagnosis of leprosy. Photo: reproduction
“Neglected tropical diseases, which are important in our country, do not attract the interest of the industry. With the NAT Leprosy Kit, we have a national test, with world-class quality, which can contribute to the health of our population”, adds the F researcheriocruz-PR, Alexandre Costa, who coordinated the development of the exam at IBMP.
The NAT Leprosy Kit is the first commercial molecular test for the disease developed in Brazil and the second exam of this type to be registered by Anvisa. Over years of research, the project received investments from the Ministry of Health, the National Council for Scientific and Technological Development (CNPq), the Coordination for the Improvement of Higher Education Personnel (Capes), the Novartis Foundation and the Leprosy Research Initiative (international initiative to support leprosy research), in addition to F's own resourcesiocruz and the IBMP.
One of humanity's oldest diseases, with case reports dating back to 600 BC, leprosy is a serious public health problem, especially in Brazil. The country has the second highest number of cases in the world. In addition, among the people affected annually, more than two thousand are diagnosed late, with neurological injuries that cause visible deformities and impair vision or movement of hands or feet.
The leprosy bacteria mainly affects the skin and nerves. Among the most common symptoms of the disease are spots on the skin, which may change sensitivity to cold, heat or pain. Even without spots, areas of the skin with altered sensitivity, decreased hair and sweating can also be a sign of the condition, as well as the appearance of lumps on the body, tingling or stinging sensations and neurological impairment, including sensory, motor or anatomical alterations .
About 70% of people with leprosy are diagnosed in primary care, by the general practitioner, without the need for additional tests. When in doubt, patients are referred for specialized care with a dermatologist. However, there are cases in which even the specialist has difficulty confirming the diagnosis. In these situations, the doctor may request a biopsy, which is the removal of skin fragments for analysis.
According to Milton, it is precisely in these cases that the NAT Leprosy Kit can be a valuable ally. The tests currently available are bacilloscopy, which seeks to visualize the bacteria, and histopathology, which analyzes changes in the tissue. In relation to these techniques, the molecular test has an important advantage: increased sensitivity.
“Bacilloscopy is usually negative in patients who have few skin lesions. In these cases, called paucibacillary, we observed that the sensitivity of histopathology is 35%, while the PCR test reaches 57%. This means that, out of every 35 patients with paucibacillary leprosy, histopathology is able to identify 57 and PCR, 65. The combination of the two tests can increase sensitivity to XNUMX%. It is an important gain”, says the researcher.
The development of the NAT Leprosy Kit is the result of decades of pioneering research with the aim of contributing to the Unified Health System (SUS). National reference center with the Ministry of Health, the Leprosy Laboratory of the IOC operates in research, teaching and patient care, which is carried out through the Souza Araújo Outpatient Clinic.
Polymerase chain reaction, known by the acronym in English PCR, was invented in 1985. In 1993, the Leprosy Laboratory was the first in Brazil to apply the technique for detecting M . leprosy.
Subsequently, the researchers improved the methodology based on the real-time PCR technique, which simplified and made the procedure cheaper. Studies carried out by several researchers and graduate students from the IOC were fundamental to the success of the project.
The last stage of the work consisted of standardizing the methodology, with reproducibility and stability studies, which are essential for registration with Anvisa. The development was carried out in partnership with IBMP, responsible for producing kits used for the molecular diagnosis of various diseases in the SUS, such as HIV, hepatitis, dengue, Zika and chikungunya.
“Production with good manufacturing practices, with batch-to-batch quality control, guarantees the performance of the exam in different laboratories”, emphasizes Alexandre.
Registration with Anvisa allows the test to be sold and is a requirement for the test to be offered on the SUS. The adoption of the methodology depends on the evaluation of the National Commission for the Incorporation of Technologies in the Unified Health System (Conitec), which sends the recommendation to the Ministry of Health, responsible for the final decision. “If the kit is approved, we have large-scale production capacity to serve the Brazilian population”, highlights Milton.
In Brazil, leprosy occurs in all states, with most records in the Midwest, North and Northeast. Like other neglected diseases, the infection is associated with poverty. People with precarious housing and food conditions are more likely to get sick from leprosy. The difficulty for vulnerable populations to access health services is one of the challenges for early diagnosis of the condition.
In 2020, the Covid-19 pandemic made disease control actions even more difficult. According to the Ministry of Health, preliminary figures indicate that less than 14 cases were diagnosed last year, against more than 27 in 2019. Experts believe that the reduction may have occurred due to the overload of health services and patients' fear of seek care.
Leprosy treatment is offered free of charge by the SUS. Made with a combination of antibiotics, it lasts between six and 12 months. Recently, the efficacy of the therapy was confirmed in a survey carried out at Ambulatório Souza Araújo. Soon after starting treatment, patients stop eliminating bacteria in nasal secretions, speech droplets, coughing, sneezing, interrupting the transmission of the disease.
A new diagnostic test developed by researchers at the Oswaldo Cruz Foundation (Fiocruz) can contribute to coping with leprosy. Based on the PCR methodology, the NAT Leprosy Kit was registered at the National Health Surveillance Agency (Anvisa). The exam detects the DNA of the Mycobacterium leprae bacillus, which causes the disease, and can facilitate the early detection of the disease, which affects, on average, 27 people per year in Brazil.
The innovation was developed by the Oswaldo Cruz Institute (IOC/Fiocruz) in partnership with the Carlos Chagas Institute (Fiocruz-PR) and the Institute of Molecular Biology of Paraná (IBMP), linked to Fiocruz and the government of Paraná. The researchers underscore the importance of applying cutting-edge methodology against a neglected disease.
“Until then, there were no diagnostic tests for leprosy that were considered the gold standard. It is a milestone to make this test available to vulnerable populations, who are the ones who most develop the disease and need technological advances”, says the project leader and head of the Leprosy Laboratory of the IOC, Milton Ozório Moraes.
National creation: after decades of research by the Fiocruz, Brazil wins the country's first molecular test for the diagnosis of leprosy. Photo: reproduction
“Neglected tropical diseases, which are important in our country, do not attract the interest of the industry. With the NAT Leprosy Kit, we have a national test, with world-class quality, which can contribute to the health of our population”, adds the F researcheriocruz-PR, Alexandre Costa, who coordinated the development of the exam at IBMP.
The NAT Leprosy Kit is the first commercial molecular test for the disease developed in Brazil and the second exam of this type to be registered by Anvisa. Over years of research, the project received investments from the Ministry of Health, the National Council for Scientific and Technological Development (CNPq), the Coordination for the Improvement of Higher Education Personnel (Capes), the Novartis Foundation and the Leprosy Research Initiative (international initiative to support leprosy research), in addition to F's own resourcesiocruz and the IBMP.
One of humanity's oldest diseases, with case reports dating back to 600 BC, leprosy is a serious public health problem, especially in Brazil. The country has the second highest number of cases in the world. In addition, among the people affected annually, more than two thousand are diagnosed late, with neurological injuries that cause visible deformities and impair vision or movement of hands or feet.
The leprosy bacteria mainly affects the skin and nerves. Among the most common symptoms of the disease are spots on the skin, which may change sensitivity to cold, heat or pain. Even without spots, areas of the skin with altered sensitivity, decreased hair and sweating can also be a sign of the condition, as well as the appearance of lumps on the body, tingling or stinging sensations and neurological impairment, including sensory, motor or anatomical alterations .
About 70% of people with leprosy are diagnosed in primary care, by the general practitioner, without the need for additional tests. When in doubt, patients are referred for specialized care with a dermatologist. However, there are cases in which even the specialist has difficulty confirming the diagnosis. In these situations, the doctor may request a biopsy, which is the removal of skin fragments for analysis.
According to Milton, it is precisely in these cases that the NAT Leprosy Kit can be a valuable ally. The tests currently available are bacilloscopy, which seeks to visualize the bacteria, and histopathology, which analyzes changes in the tissue. In relation to these techniques, the molecular test has an important advantage: increased sensitivity.
“Bacilloscopy is usually negative in patients who have few skin lesions. In these cases, called paucibacillary, we observed that the sensitivity of histopathology is 35%, while the PCR test reaches 57%. This means that, out of every 35 patients with paucibacillary leprosy, histopathology is able to identify 57 and PCR, 65. The combination of the two tests can increase sensitivity to XNUMX%. It is an important gain”, says the researcher.
The development of the NAT Leprosy Kit is the result of decades of pioneering research with the aim of contributing to the Unified Health System (SUS). National reference center with the Ministry of Health, the Leprosy Laboratory of the IOC operates in research, teaching and patient care, which is carried out through the Souza Araújo Outpatient Clinic.
Polymerase chain reaction, known by the acronym in English PCR, was invented in 1985. In 1993, the Leprosy Laboratory was the first in Brazil to apply the technique for detecting M . leprosy.
Subsequently, the researchers improved the methodology based on the real-time PCR technique, which simplified and made the procedure cheaper. Studies carried out by several researchers and graduate students from the IOC were fundamental to the success of the project.
The last stage of the work consisted of standardizing the methodology, with reproducibility and stability studies, which are essential for registration with Anvisa. The development was carried out in partnership with IBMP, responsible for producing kits used for the molecular diagnosis of various diseases in the SUS, such as HIV, hepatitis, dengue, Zika and chikungunya.
“Production with good manufacturing practices, with batch-to-batch quality control, guarantees the performance of the exam in different laboratories”, emphasizes Alexandre.
Registration with Anvisa allows the test to be sold and is a requirement for the test to be offered on the SUS. The adoption of the methodology depends on the evaluation of the National Commission for the Incorporation of Technologies in the Unified Health System (Conitec), which sends the recommendation to the Ministry of Health, responsible for the final decision. “If the kit is approved, we have large-scale production capacity to serve the Brazilian population”, highlights Milton.
In Brazil, leprosy occurs in all states, with most records in the Midwest, North and Northeast. Like other neglected diseases, the infection is associated with poverty. People with precarious housing and food conditions are more likely to get sick from leprosy. The difficulty for vulnerable populations to access health services is one of the challenges for early diagnosis of the condition.
In 2020, the Covid-19 pandemic made disease control actions even more difficult. According to the Ministry of Health, preliminary figures indicate that less than 14 cases were diagnosed last year, against more than 27 in 2019. Experts believe that the reduction may have occurred due to the overload of health services and patients' fear of seek care.
Leprosy treatment is offered free of charge by the SUS. Made with a combination of antibiotics, it lasts between six and 12 months. Recently, the efficacy of the therapy was confirmed in a survey carried out at Ambulatório Souza Araújo. Soon after starting treatment, patients stop eliminating bacteria in nasal secretions, speech droplets, coughing, sneezing, interrupting the transmission of the disease.
The non-profit reproduction of the text is allowed as long as the source is cited (Comunicação / Instituto Oswaldo Cruz)
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