Evaluation and validation of a PrintrLab-based LAMP assay to identify Trypanosoma cruzi in newborns in Bolivia: a proof-of-concept study.

Autor:	Rojas Panozo L; Fundación Ciencias y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia., Rivera Nina S; Fundación Ciencias y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia., Wehrendt DP; Laboratorio de Biología Molecular de La Enfermedad de Chagas, Instituto de Investigaciones en Ingeniería Genética y Biología Molecular 'Dr. Héctor N. Torres' (INGEBI), Buenos Aires, Argentina., Casellas A; Barcelona Institute for Global Health (ISGlobal), Hospital Clinic - University of Barcelona, Barcelona, Spain., Pinto L; Fundación Ciencias y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia., Mendez S; Barcelona Institute for Global Health (ISGlobal), Hospital Clinic - University of Barcelona, Barcelona, Spain., Kuo CW; AI Biosciences, College Station, TX, USA., Lozano DF; Fundación Ciencias y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia; Universidad Mayor de San Simón, Cochabamba, Bolivia., Ortiz L; Plataforma de Chagas Tarija - Universidad Autónoma Juan Misael Saracho, Tarija, Bolivia., Pinazo MJ; Drugs for Neglected Diseases Initiative (DNDi), Rio de Janeiro, Brazil; CIBER de Enfermedades Infecciosas (CIBERINFEC), Madrid, Spain., Picado A; Foundation for Innovative Diagnostics (FIND), Geneva, Switzerland., Sanz S; Barcelona Institute for Global Health (ISGlobal), Hospital Clinic - University of Barcelona, Barcelona, Spain., Abril M; Fundación Mundo Sano, Buenos Aires, Argentina., Gascon J; Barcelona Institute for Global Health (ISGlobal), Hospital Clinic - University of Barcelona, Barcelona, Spain; CIBER de Enfermedades Infecciosas (CIBERINFEC), Madrid, Spain., Wong S; AI Biosciences, College Station, TX, USA., Schijman AG; Laboratorio de Biología Molecular de La Enfermedad de Chagas, Instituto de Investigaciones en Ingeniería Genética y Biología Molecular 'Dr. Héctor N. Torres' (INGEBI), Buenos Aires, Argentina., Torrico F; Fundación Ciencias y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Cochabamba, Bolivia; Universidad Mayor de San Simón, Cochabamba, Bolivia., Alonso-Padilla J; Barcelona Institute for Global Health (ISGlobal), Hospital Clinic - University of Barcelona, Barcelona, Spain; CIBER de Enfermedades Infecciosas (CIBERINFEC), Madrid, Spain. Electronic address: julio.a.padilla@isglobal.org.
Jazyk:	angličtina
Zdroj:	The Lancet. Microbe [Lancet Microbe] 2024 Sep; Vol. 5 (9), pp. 100887. Date of Electronic Publication: 2024 Jul 03.
DOI:	10.1016/S2666-5247(24)00110-1
Abstrakt:	Background: Vertical transmission of Trypanosoma cruzi represents approximately 20% of new Chagas disease cases. Early detection and treatment for women of childbearing age and newborns is a public health priority, but the lack of a simple and reliable diagnostic test remains a major barrier. We aimed to evaluate the performance of a point-of-care loop-mediated isothermal amplification (LAMP) assay for the detection of T cruzi. Methods: In this proof-of-concept study, we coupled a low-cost 3D printer repurposed for sample preparation and amplification (PrintrLab) to the Eiken T cruzi-LAMP prototype to detect vertically transmitted T cruzi, which we compared with standardised PCR and with the gold-standard algorithm (microscopy at birth and 2 months and serological study several months later). We screened pregnant women from two hospitals in the Bolivian Gran Chaco province, and those who were seropositive for T cruzi were offered the opportunity for their newborns to be enrolled in the study. Newborns were tested by microscopy, LAMP, and PCR at birth and 2 months, and by serology at 8 months. Findings: Between April 23 and Nov 17, 2018, 986 mothers were screened, among whom 276 were seropositive for T cruzi (28·0% prevalence, 95% CI 25·6-31·2). In total, 224 infants born to 221 seropositive mothers completed 8 months of follow-up. Congenital transmission was detected in nine of the 224 newborns (4·0% prevalence, 1·9-7·5) by direct microscopy observation, and 14 more cases were diagnosed serologically (6·3%, 3·6-10·3), accounting for an overall vertical transmission rate of 10·3% (6·6-15·0; 23 of 224). All microscopy-positive newborns were positive by PrintrLab-LAMP and by PCR, while these techniques respectively detected four and five extra positive cases among the remaining 215 microscopy-negative newborns. Interpretation: The PrintrLab-LAMP yielded a higher sensitivity than microscopy-based analysis. Considering the simpler use and expected lower cost of LAMP compared with PCR, our findings encourage its evaluation in a larger study over a wider geographical area. Funding: Inter-American Development Bank. Competing Interests: Declaration of interests C-WK and SW are employees at AI Biosciences, the biotechnology company that developed the PrintrLab. All other authors declare no competing interests. (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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