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Rapid diagnostic tests duo as alternative to conventional serological assays for conclusive Chagas disease diagnosis
Karina E Egüez1, Julio Alonso-Padilla2, Carolina Terán3
1Departmental Reference Laboratory, Chuquisaca Departmental Health Service (SEDES-Chuquisaca), Sucre, Bolivia.
Insights
Diagnosing Chagas disease in remote areas is challenging. This study validates two rapid diagnostic tests (RDTs) for accurate, timely diagnosis, enabling earlier treatment of Trypanosoma cruzi infection.
Area of Science:
- Neglected tropical diseases
- Parasitology
- Infectious disease diagnostics
Background:
- Chagas disease, caused by Trypanosoma cruzi, affects millions, primarily in Latin America, with severe cardiac/digestive complications in 30% of chronic cases.
- Current diagnosis relies on conventional serological methods (ELISA, IHA) requiring equipped labs and trained personnel, often unavailable in remote regions.
- Early diagnosis is crucial as available treatments are less effective in advanced chronic stages.
Purpose of the Study:
- To evaluate the parallel use of two rapid diagnostic tests (RDTs) for conclusive Chagas disease diagnosis using whole blood.
- To assess if combined RDTs can replace conventional serology in resource-limited settings.
Main Methods:
- Two distinct RDTs, Chagas Stat-Pak and Chagas Detect Plus, were used in parallel with whole blood samples.
- Performance was validated against three conventional serological tests in 342 patients at a reference center in Sucre, Bolivia.
Main Results:
- The combined use of Chagas Stat-Pak and Chagas Detect Plus demonstrated 100% sensitivity and 99.3% specificity.
- The RDTs provided accurate results within an hour, without needing electricity or a cold chain.
Conclusions:
- Parallel application of validated RDTs offers a fast, reliable alternative to conventional serology for Chagas disease diagnosis in remote areas.
- This approach facilitates immediate treatment initiation, potentially improving patient adherence and outcomes for Trypanosoma cruzi infections.
Abstract:
Chagas disease is caused by the parasite Trypanosoma cruzi. It affects several million people, mainly in Latin America, and severe cardiac and/or digestive complications occur in ~30% of the chronically infected patients. Disease acute stage is mostly asymptomatic and infection goes undiagnosed. In the chronic phase direct parasite detection is hampered due to its concealed presence and diagnosis is achieved by serological methods, like ELISA or indirect hemagglutination assays. Agreement in at least two tests must be obtained due to parasite wide antigenic variability. These techniques require equipped labs and trained personnel and are not available in distant regions. As a result, many infected people often remain undiagnosed until it is too late, as the two available chemotherapies show diminished efficacy in the advanced chronic stage. Easy-to-use rapid diagnostic tests have been developed to be implemented in remote areas as an alternative to conventional tests. They do not need electricity, nor cold chain, they can return results within an hour and some even work with whole blood as sample, like Chagas Stat-Pak (ChemBio Inc.) and Chagas Detect Plus (InBIOS Inc.). Nonetheless, in order to qualify a rapidly diagnosed positive patient for treatment, conventional serological confirmation is obligatory, which might risk its start. In this study two rapid tests based on distinct antigen sets were used in parallel as a way to obtain a fast and conclusive Chagas disease diagnosis using whole blood samples. Chagas Stat-Pak and Chagas Detect Plus were validated by comparison with three conventional tests yielding 100% sensitivity and 99.3% specificity over 342 patients seeking Chagas disease diagnosis in a reference centre in Sucre (Bolivia). Combined used of RDTs in distant regions could substitute laborious conventional serology, allowing immediate treatment and favouring better adhesion to it.
