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Trypanosoma cruzi infection is diagnosed by parasitological, molecular, and serological tests. Molecular methods based on DNA amplification provide a more sensitive alternative to classical parasitological techniques for detecting evidence of T. cruzi parasitemia, and are the preferred tests for congenital and oral transmission cases and parasite reactivation in chronically infected immunosuppressed individuals. In newborns at risk of vertical transmission, simplified diagnostic algorithms that provide timely results can reduce the high follow-up losses observed with current algorithms. Molecular methods have also proved useful for monitoring T. cruzi infection in solid organ transplantation recipients, regardless of host immune status, allowing parasite detection even before symptom manifestation. Furthermore, in the absence of other biomarkers and a practical test of cure, and given the limitations of serological methods, recent clinical guidelines have included polymerase chain reaction (PCR) to detect therapeutic failure after antiparasitic treatment in chronically infected adults. Increasing evidence supports the use of molecular tests in a clinical context, given the improved sensitivity and specificity of current assays – characteristics which largely depend on epidemiological factors and genetic and antigenic variability among T. cruzi strains. Further development and registration of commercial PCR kits will improve the use of molecular tests. We discuss the attributes of PCR and other molecular tests for clinical management in people with T. cruzi infection.

BackgroundChagas disease is a public health challenge in Colombia, where only an estimated 1.2% of people at risk have accessed diagnosis, while less than 0.5% of affected people have obtained treatment. The development of simplified diagnostic algorithms would enable progress in access to diagnosis; however, the current diagnostic algorithm relies on at least two laboratory-based tests that require qualified personnel, processing equipment, and infrastructure, which are still generally lacking at the primary care level. Rapid diagnostic tests (RDTs) for Chagas disease could simplify diagnosis, but their performance in the epidemiological context of Colombia is not well known.MethodologyA retrospective analytical observational study of RDTs was performed to estimate the operational characteristics of 11 commercially available RDTs designed for in vitro detection of anti-T. cruzi IgG antibodies. The study was performed under controlled laboratory conditions using human serum samples.Principal findingsEleven RDTs were assessed, ten using 585 serum samples and one using 551 serum samples. Employing the current national diagnostic algorithm as a reference standard for serological diagnosis of chronic infection, the sensitivity of the assessed RDTs ranged from 75.5% to 99.0% (95% CI 70.5-100), while specificity ranged from 70.9% to 100% (95% CI 65.3-100). Most tests (7/11, 63.6%) had sensitivity above 90%, and almost all (10/11, 90.9%) had specificity above 90%. Five RDTs had both sensitivity and specificity above 90%.Conclusions/significanceThe evaluation of these 11 commercially available RDTs under controlled laboratory conditions is a first step in the assessment of the diagnostic performance of RDTs in Colombia. As a next step, field studies will be conducted on available RDTs with sensitivity and specificity greater than 90% in this study, to evaluate performance in real world conditions, with the final goal to allow simplified diagnostic algorithms.

Objective: Chagas disease affects over six million people, but less than 1% are diagnosed and treated. Complicated diagnostic processes are a major barrier. Colombia’s previous diagnostic algorithm, using in-house tests, was difficult to scale up, creating significant access barriers for patients. A new algorithm using commercially manufactured immunoassays would potentially improve access, but these tests’ performance in Colombian patients with Chagas disease is not well known. Methods: We assessed seven commercially available assays. Samples (n = 501), 93.8% originating from Colombia, were characterized as positive or negative based on standard procedure at the National Reference Laboratory. Performance characteristics were calculated for individual assays and hypothetical test pairings, then compared to the existing algorithm. Results: Five of seven assays exhibited sensitivity >98% while six showed specificity >97%. A total antigen ELISA paired with a recombinant assay provided similar performance to the current diagnostic process. Six of six assays tested proved capable of detecting different Trypanosoma cruzi genetic lineages. Conclusions: The study indicated that several commercial assays accurately detect T. cruzi infection in Colombian patients. A simplified testing process with two commercial assays could perform comparably to the previous process, reducing cost and accessibility barriers and facilitating national scale-up. Keywords: Trypanosoma cruzi, Chagas disease, Enzyme-linked immunosorbent assays, Diagnostic barriers, Access to healthcare, Neglected tropical diseases (NTDs)

The vast majority of people with Chagas disease (CD) are undiagnosed and untreated. Improving access to diagnosis and treatment for CD involves confronting a wide range of barriers. This report discusses a collaborative approach to eliminate barriers and increase the availability of CD testing and treatment. Potential areas for intervention are selected based on burden of disease, support of local champions, and commitment from national and local authorities. A 4D approach (diagnose, design, deliver, and demonstrate impact) is then implemented. The diagnose step involves gathering key stakeholders at a seminar to collaboratively identify important barriers and propose solutions. The design step creates a specific plan to act upon the seminars conclusions with consensus on core indicators. The deliver step entails implementing the plan at pilot locations, while simultaneously strengthening health system capacity for CD testing and treatment. Lastly, the demonstrate impact step compares baseline data with annual post-implementation data to measure progress. In Colombia, this approach has helped simplify testing procedures and increase CD testing and treatment access in pilot communities, though challenges remain. The 4D approach represents one of several pathways toward ensuring that the best therapeutic and diagnostic products reach people affected by neglected tropical diseases.

Objectives: This paper presents the results of the design and implementation process for the policy of compulsory notification of chronic Chagas disease in the Brazilian state of Goiás (Resolution No. 004/2013-GAB/SES-GO). Methods: The narrative was based on information provided by key actors that were part of the different stages of the process, built on contextual axes based on participants’ reflections about the establishment of the most accurate and coherent notification mechanisms. Results: The notification policy addressed the absence of historical data from patients in the state Chagas program, an increase in cases identified through serology, and weaknesses in vector control. Two key challenges involved human resources capacity and dissemination to public agencies and health care workers. Effective training and communication processes were key ingredients for successful implementation. Conclusions: The lack of public health measures aimed at the epidemiological surveillance of chronic Chagas cases constitutes a significant barrier for patients to access appropriate diagnosis, management and follow-up, and hampers the planning of necessary activities within health systems. The implementation of the notification policy in Goiás allows authorities to determine the real magnitude of Chagas disease in the population, so that an appropriate public health response can be mounted to meet the needs of affected people, thereby ending the epidemiological silence of Chagas disease.

Between 1999-2002, Médécins Sans Frontières-Spain implemented a project seeking to determine the efficacy and safety of benznidazole in the treatment of recent chronic Chagas disease in a cohort of seropositive children in the Yoro Department, Honduras. A total of 24,471 children were screened for Trypanosoma cruzi IgG antibodies through conventional enzyme-linked immunosorbent assays (ELISA) on filter paper. Recombinant ELISA (0.93% seroprevalence) showed 256 initially reactive cases, including 232 confirmed positive cases. Of these, 231 individuals were treated with benznidazole (7.5 mg/kg/day) for 60 days and were followed with a strict weekly medical control and follow-up protocol. At the end of the project, 229 patients were examined by the Honduras Secretariat of Health for post-treatment serological assessments; 88.2% seroconverted after 18 months and 93.9% seroconverted after three years. No differences were found in the seroconversion rates according to age or sex. Most of the side effects of the treatment were minor. These results support the argument that in areas where T. cruzi I is predominant and in areas affected by T. cruzi II, when vector transmission has been interrupted, Chagas disease diagnosis and treatment are feasible, necessary and ethically indisputable.