Rapid tests could be used to diagnose Chagas disease in resource-limited areas, according to a study led by the Barcelona Institute for Global Health (ISGlobal). The results of this research, published in PLOS Neglected Tropical Diseases, show that the prevalence of Chagas in an indigenous community in Paraguay is six times higher than in the country's capital.
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Chagas disease, caused by the parasite Trypanosoma cruzi, is a serious public health problem in the Americas. Between six and seven million people suffer from the disease, which is mainly transmitted by insect vectors. Under-diagnosis is one of the main obstacles in the fight against the parasite, reflected in the fact that less than 1% of those affected receive treatment.
Chagas is primarily diagnosed by serological techniques—the detection of antibodies to T. cruzi in the blood—during the chronic phase of the disease. To improve diagnostic access, Paraguayan health authorities proposed a new algorithm for resource-limited settings: a combination of rapid diagnostic tests (RDTs) followed by conventional serological tests, such as enzyme-linked immunosorbent assay (ELISA).
"In July , we conducted a two-week screening campaign in the endemic community of Casanillo (an indigenous community in the Paraguayan Chaco), involving 999 people," explains Sofía Ardiles Ruesjas, ISGlobal researcher and first author of the study.
"We were able to verify the effectiveness of the combination of RDTs and serological tests compared to the standard method recommended by PAHO and WHO, which relies solely on conventional serological tests," she adds.
Although they have good sensitivity and specificity, conventional serological tests require specialized personnel and equipment, which are often in short supply in endemic regions. Even when these resources are available, access to health centers can be a challenge for local people.
The use of rapid diagnostic tests offers a new approach: they are easy to use, require only a minimal sample volume (blood from a finger prick), do not require special equipment, and ensure rapid delivery of results. The algorithm validated in the study suggests using RDTs for an initial screening of at-risk individuals in endemic areas, thereby reducing the need for serological testing to confirm positive results.
"Each participant underwent a rapid diagnostic test (RDT), and those with a positive result were confirmed using two different serological techniques (recombinant ELISA and lysate ELISA)," explains the ISGlobal researcher.
The study results of the study showed a seroprevalence (percentage of people with antibodies against T. cruzi) of 12.6% in the community of Casanillo, a figure significantly higher than the 2.1% estimated from blood banks in Asunción. This highlights the health inequalities between urban and rural areas.
The algorithm using rapid diagnostic tests (RDTs) showed high agreement with the standard algorithm, with a sensitivity of 94.6% and a specificity of 98.6%. These results are crucial for public health initiatives, as they validate the combined use of RDTs and conventional serology, an algorithm proposed by Paraguayan health authorities for resource-limited settings.
"The results obtained are particularly relevant in the context of a global re-evaluation of guidelines for the diagnosis and treatment of Chagas disease," says Irene Losada, coordinator of the Chagas Initiative at ISGlobal and senior author of the study. "The adoption of RDT-based algorithms adapted to each region could improve access to diagnosis for thousands of people in remote areas," she concludes.
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Colombia’s National Institute of Health (Instituto Nacional de Salud, or INS) has presented technical guidelines for the use of rapid diagnostic tests to detect antibodies against Trypanosoma cruzi, the parasite that causes Chagas disease.
The recommendations, announced on 21 May, should help doctors and other healthcare providers diagnose patients earlier – and therefore accelerate access to life-saving treatment. They are the result of a series of studies conducted in Colombia by the INS with technical support from the not-for-profit medical research organization Drugs For Neglected Diseases initiative (DNDi).
The announcement represents a milestone in expanding access to diagnosis and treatment for patients with Chagas disease, especially in remote areas and among vulnerable populations.
Since , Chagas disease serological diagnosis in Colombia has relied on two laboratory-based ELISA tests. However, difficulty accessing these tests, particularly in remote regions that are far from the specialized facilities that perform them, has limited timely diagnosis. Since starting antiparasitic treatment as soon as possible is essential to preventing the progression of Chagas disease, early diagnosis is key to efforts to eliminate this deadly neglected disease as a public health problem.
To address challenges in access to timely diagnosis, three studies were conducted that provide the evidence needed to support the new technical guidelines and ensure the appropriate use of rapid tests that are faster and far simpler than traditional laboratory-based testing. These included 1) a comparative retrospective evaluation of 11 different rapid test kits for Chagas disease under laboratory conditions, 2) a prospective study to assess the performance of four rapid tests in pregnant women, including members of Indigenous communities, and 3) a prospective study to evaluate the performance of two rapid tests when used in parallel in the general population.
The new recommendations based on these studies apply to all healthcare institutions and providers who will use rapid tests to diagnose Chagas disease in the country.
‘Since , Colombia has made progress in Chagas disease diagnosis, but we still face challenges in ensuring timely testing, especially in rural areas,’ said Diana Pava, General Director of the INS. ‘That’s why implementing a diagnostic algorithm using rapid tests is so important to improve access to diagnosis and treatment for chronic Trypanosoma cruzi infection.’
‘Rapid tests can transform access to diagnosis in Colombia if they are implemented effectively and appropriately in the most affected areas,’ said Andrea Marchiol, DNDi’s Medical Coordinator for Chagas Access Projects in Latin America. ‘We want this innovation to be more than just a recommendation – we want it to represent a real and sustainable shift in access to quality healthcare for people affected by Chagas disease in the region.’
The success of the Colombian experience could also serve as a model for other countries, added Marchiol. ‘The impact of this collaborative process should not be limited to Colombia. This is an example that can be adapted by other countries where Chagas disease is endemic.’
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected populations. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, river blindness, mycetoma, dengue, paediatric HIV, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health; gender equity and gender-responsive R&D; and diseases impacted by climate change. Since its creation in , DNDi has collaborated with public and private partners worldwide to deliver twelve new treatments for six deadly diseases, saving millions of lives. dndi.org
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