Accuracy, acceptability, and feasibility of diagnostic tests for the screening of Strongyloides stercoralis in the field (ESTRELLA): a cross-sectional study in Ecuador

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  • Francesca Tamarozzi
  • Ángel G. Guevara
  • Mariella Anselmi
  • Yosselin Vicuña
  • Rosanna Prandi
  • Monica Marquez
  • Sandra Vivero
  • Francisco Robinzón Huerlo
  • Marcia Racines
  • Cristina Mazzi
  • Denwood, Matt
  • Dora Buonfrate

Background: WHO recommends the implementation of control programmes for strongyloidiasis, a neglected tropical disease caused by Strongyloides stercoralis. Specific recommendations on the diagnostic test or tests to be used for such programmes have yet to be defined. The primary objective of this study was to estimate the accuracy of five tests for strongyloidiasis. Secondary objectives were to evaluate acceptability and feasibility of use in an endemic area. Methods: The ESTRELLA study was a cross-sectional study for which we enrolled school-age children living in remote villages of Ecuador. Recruitment took place in two periods (Sept 9–19, 2021, and April 18–June 11, 2022). Children supplied one fresh stool sample and underwent blood collection via finger prick. Faecal tests were a modified Baermann method and an in-house real-time PCR test. Antibody assays were a recombinant antigen rapid diagnostic test; a crude antigen-based ELISA (Bordier ELISA); and an ELISA based on two recombinant antigens (Strongy Detect ELISA). A Bayesian latent class model was used to analyse the data. Findings: 778 children were enrolled in the study and provided the required samples. Strongy Detect ELISA had the highest sensitivity at 83·5% (95% credible interval 73·8–91·8), while Bordier ELISA had the highest specificity (100%, 99·8–100). Bordier ELISA plus either PCR or Baermann had the best performance in terms of positive and negative predictive values. The procedures were well accepted by the target population. However, study staff found the Baermann method cumbersome and time-consuming and were concerned about the amount of plastic waste produced. Interpretation: The combination of Bordier ELISA with either faecal test performed best in this study. Practical aspects (including costs, logistics, and local expertise) should, however, also be taken into consideration when selecting tests in different contexts. Acceptability might differ in other settings. Funding: Italian Ministry of Health. Translation: For the Spanish translation of the abstract see Supplementary Materials section.

OriginalsprogEngelsk
TidsskriftThe Lancet Global Health
Vol/bind11
Udgave nummer5
Sider (fra-til)e740-e748
ISSN2214-109X
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
This work received funds from the Italian Ministry of Health: “5 × 1000, 2019”, project: “Fundamental study on accuracy of diagnostic assays in endemic areas: towards the integration of strongyloidiasis into the WHO preventive chemotherapy programmes” and “Ricerca Corrente”, project: L2P5. We warmly thank InsudPharma and Mundo Sano for the donation of ivermectin, and InBios International for the donation of the Strongy Detect ELISA assays. We are also grateful to Bordier Affinity Products for supplying the ELISA kits at a substantially reduced cost. The BLCA was developed as part of the COST Action CA18208: HARMONY—Novel tools for test evaluation and disease prevalence estimation. We thank Rahmah Noordin, from Universiti Sains Malaysia, for supplying the RDT. We are grateful to Antonio Montresor, from the Department of Control of Neglected Tropical Diseases, WHO, Geneva, for his support to solve logistic issues and for mediating drug donation. Last but not least, we warmly acknowledge all participants and their parents or guardians and teachers, and all community health workers, whose high commitment was fundamental to carrying out this project: Olaice Cortéz Carabalí (comunidad Calderón), Judith Rendon Vivero (comunidad Carondelet), Maritza Boboy Porozo (comunidad S. Francisco), Bercelia Mina Nazareno (comunidad Santa Rita), Gloria Andrade Cetre (comunidad Tambillo), Matilde Castillo Cuajiboy (comunidad La Boca), María Hilda Cuajiboy (comunidad El Guadual), Karina Chillambo Klinger (comunidad Ricaurte), Roberta Ordóñez Arevalo (comunidad Ricaurte), Sorana Márquez Cuero (comunidad Km 9), María Sabando Pinargote (comunidad Km 9), and Roger Quiñónez Diaz (comunidad Km 9).

Publisher Copyright:
© 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license

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