Validation of NAT Chagas and LAMP Chagas for the diagnosis of patients and foods involved in oral outbreaks of Chagas disease

Comparative validation of the Biomol Chagas (NAT Chagas) and Loopamp (LAMP Chagas) kits in samples from acute and recent chronic patients and food involved in oral outbreaks of Chagas disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

REBEC

Registry ID

RBR-34sj2yx

Enrollment

400

Registered

2026-04-01

Start date

2025-01-02

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chagas Disease Infections

Interventions

This is an observational study of diagnostic accuracy. This study will compare the efficacy of two index tests, qPCR (Biomol Chagas kit, IBMP) and LAMP (Loopamp Chagas kit, Eiken), against the gold st

Eligibility

Age

1 Years to No maximum

Inclusion criteria

Inclusion criteria: The study is conducted with people of both sexes, being individuals aged 1 year and older with clinical and/or epidemiological suspicion of Chagas disease transmitted orally or who have undergone direct parasitological and/or serological examinations with confirmed results; Must have voluntarily signed the Informed Consent Form and/or Informed Consent Form for the study; Participants who agree to provide sufficient biological material for analysis

Exclusion criteria

Exclusion criteria: Having received specific treatment with Benznidazole, Nifurtimox, or any agent with recognized trypanocidal activity less than 1 year ago; For individuals in the chronic phase, with proven infection by Trypanosoma cruzi that occurred more than 1 year ago; Indigenous population

Design outcomes

Primary

Measure	Time frame
The primary outcome to be observed is the accuracy of both index tests (IBMP Biomol Chagas and LAMP Chagas) compared to the in-house qPCR reference test. The accuracy parameters will primarily be assessed based on the sensitivity and specificity of the tests compared to the in-house qPCR. The same applies to food samples collected from the locations where outbreaks occurred. The accuracy (sensitivity and specificity) of T. cruzi DNA detection by IBMP Agro T. cruzi Biomol Chagas and LAMP in these foods will be compared to the in-house qPCR.	—

Measure

Time frame

The primary outcome to be observed is the accuracy of both index tests (IBMP Biomol Chagas and LAMP Chagas) compared to the in-house qPCR reference test. The accuracy parameters will primarily be assessed based on the sensitivity and specificity of the tests compared to the in-house qPCR. The same applies to food samples collected from the locations where outbreaks occurred. The accuracy (sensitivity and specificity) of T. cruzi DNA detection by IBMP Agro T. cruzi Biomol Chagas and LAMP in these foods will be compared to the in-house qPCR.

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Secondary

Measure	Time frame
Within the analysis of the performance of the IBMP Biomol Chagas and LAMP Chagas kits in diagnosing patients involved in oral outbreaks of Chagas disease, as well as the analysis of foods that may have been the source of contamination, the main secondary outcome to be observed is the reproducibility of the tests, as well as the sample processing capabilities, since the tests have different foundations, being indicated either for diagnosis in reference laboratories or in the field, as point-of-care.	—

Measure

Time frame

Within the analysis of the performance of the IBMP Biomol Chagas and LAMP Chagas kits in diagnosing patients involved in oral outbreaks of Chagas disease, as well as the analysis of foods that may have been the source of contamination, the main secondary outcome to be observed is the reproducibility of the tests, as well as the sample processing capabilities, since the tests have different foundations, being indicated either for diagnosis in reference laboratories or in the field, as point-of-care.

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Countries

Contacts

Public ContactOtacilio Moreira

Fundação Oswaldo Cruz

otacilio@ioc.fiocruz.br+55-21-993442257

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026