Rapid tests for detecting chronic Chagas infection at the point of care.
Prospective Multicenter Field Study for Rapid Diagnostic Tests Evaluation for Timely Detection of Chronic Chagas Disease in Public Health Sites in Argentina.
This project will test two rapid blood tests to see if they can accurately detect chronic Chagas infection in people seen at participating clinics in Argentina, including pregnant women, blood donors, and transplant recipients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3234 (estimated) |
| Ages | 10 Months and up |
| Sex | All |
| Sponsor | Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben Government |
| Locations | 4 sites (Buenos Aires, Buenos Aires and 3 other locations) |
| Trial ID | NCT07304349 on ClinicalTrials.gov |
What this trial studies
Researchers will field-test two commercial rapid diagnostic tests (RDTs) for chronic T. cruzi infection at three Buenos Aires–area hospitals and primary care settings. Participants aged 10 months and older will provide capillary and venous samples so RDT results can be compared with the standard reference serological algorithm. The study will report sensitivity, specificity, predictive values, concordance across sample types, usability, and cost-effectiveness to identify high-performance point-of-care algorithms. Results will inform whether RDTs can increase access to timely diagnosis and treatment in endemic Argentine settings.
Who should consider this trial
Good fit: Ideal participants are people aged 10 months and older who can give consent or assent, including pregnant women, blood donors, transplant recipients, and individuals suspected of chronic T. cruzi infection attending participating Argentine clinics.
Not a fit: People with prior antiparasitic treatment, immunocompromising conditions, or infants under 10 months are excluded and may not benefit from this diagnostic approach.
Why it matters
Potential benefit: If successful, validated RDTs could allow reliable diagnosis at primary care sites and shorten delays to treatment for people with chronic Chagas.
How similar studies have performed: Laboratory evaluations in 2023 showed several commercial RDTs had performance similar to reference methods, but field validation across clinical and epidemiological settings remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pregnant women, blood donors, transplant recipients, suspected chronic T. cruzi infection, \>10 months of age, with informed consent/assent. Exclusion Criteria: Previous antiparasitic treatment, immunocompromised individuals, or conditions preventing protocol implementation/interpretation.
Where this trial is running
Buenos Aires, Buenos Aires and 3 other locations
- Hospital Mercante — Buenos Aires, Buenos Aires, Argentina (Recruiting)
- Hospital Gutierrez — Buenos Aires, Buenos Aires, Argentina (Recruiting)
- Hospital Paroissien — Isidro Casanova, Buenos Aires, Argentina (Recruiting)
- Dispositivos Territoriales, Olmos — La Plata, Buenos Aires, Argentina (Recruiting)
Study contacts
- Study coordinator: Rocio Rivero, PhD
- Email: rrivero@anlis.gob.ar
- Phone: +5411 4331-4010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.