2026-10-13T22:12:38Z https://api.figshare.com/v2/oai

oai:figshare.com:article/34038852 2026-10-01T04:42:46Z category_303 portal_316 item_type_3 month_year_10_2026

Data Sheet 1_Extraction-free LAMP-LFD assay for early diagnosis of congenital Chagas disease directly from neonatal dried blood spots.pdf Luciana Larocca (10803687) Fabiana G. Stolowicz (25152222) Matilde Abudara (25152225) Esteban L. Figueroa (25152228) Gustavo Maccallini (25152231) Santiago Werbajh (270704) Adrian A. Vojnov (25152234) Claudio Aranda (25152237) Carolina Carrillo (1908580) Clinical Microbiology Chagas disease dried blood spots lateral flow assay loop-mediated isothermal amplification newborn screening point-of-care diagnostics Trypanosoma cruzi Background<p>Vertical transmission is a major driver of new Chagas disease cases. Early diagnosis in newborns is essential for effective treatment; however, conventional screening limitations and high patient attrition lead to severe under-registration. Simplified molecular tools can substantially improve early detection and treatment access.</p>Methodology/principal findings<p>We developed a simplified loop-mediated isothermal amplification (LAMP)-based assay targeting the repetitive satellite DNA of Trypanosoma cruzi for qualitative detection in newborn dried blood spots (DBS). Tailored for resource-limited settings, the protocol requires only a dry bath incubator, utilizing lateral flow dipsticks (LFD) for visual readout. The DBS sample is loaded directly into the reaction without nucleic acid extraction. Using artificially spiked DBS, the limit of detection was established at 1 fg of DNA and 1 parasite per reaction. Inclusivity was confirmed across all six T. cruzi discrete typing units (DTUs TcI–TcVI), with no cross-reactivity against heterologous or human DNA. A clinical proof-of-concept evaluation on a blinded panel of 24 newborn DBS samples (4 positive, 20 negative) achieved 100% concordance with definitive clinical status. Notably, the assay successfully identified all 4 congenital cases, including 3 that had tested negative by conventional parasitological microscopy at birth.</p>Conclusions/significance<p>This simplified, extraction-free molecular test requires minimal equipment and is fully compatible with routine newborn screening infrastructure. It provides a robust, translatable tool for early congenital Chagas diagnosis in decentralized healthcare settings, with high potential to improve detection rates and secure timely access to etiological treatment.</p> 2026-10-01T04:42:46Z Dataset Dataset 10.3389/fcimb.2026.1934037.s001 https://figshare.com/articles/dataset/Data_Sheet_1_Extraction-free_LAMP-LFD_assay_for_early_diagnosis_of_congenital_Chagas_disease_directly_from_neonatal_dried_blood_spots_pdf/34038852 CC BY 4.0