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 2017, 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 2017, 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.’
About DNDi
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 2003, DNDi has collaborated with public and private partners worldwide to deliver twelve new treatments for six deadly diseases, saving millions of lives. dndi.org
Media contacts
Vania Alves (in Rio de Janeiro)
valves@dndi.org
Frédéric Ojardias (in Geneva)
+41 79 431 62 16
fojardias@dndi.org
