Evidence map›Paper›PMID 40238804›Full record

ArticlePloS one2025

Validation of new equipment for SARS-CoV-2 diagnosis in Ecuador: Detection of the virus and antibodies generated by disease and vaccines with one POC device.

Stephany D Villota, Eliana Veloz-Villavicencio, Santiago Garcia-Iturralde, Johanna Valentina Arévalo, Suying Lu, Katariina Jaenes, Yuxiu Guo, Seray Cicek, Karen Colwill, Anne-Claude Gingras and 4 more

Abstract readValidation Study
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. A Field-Deployable RotEx-LAMP-LFA Platform for Molecular Triage of HPV-Driven Oncogenesis.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Stephany D VillotaCentro de Investigación en Enfermedades Infecciosas y Vectoriales (CIREV), Instituto Nacional de Investigación en Salud Pública (INSPI), Quito, Ecuador.ORCID 0000-0002-3250-6589
Eliana Veloz-VillavicencioCentro de Investigación en Enfermedades Infecciosas y Vectoriales (CIREV), Instituto Nacional de Investigación en Salud Pública (INSPI), Quito, Ecuador.ORCID 0000-0003-2234-2055
Santiago Garcia-IturraldeCentro de Investigación en Enfermedades Infecciosas y Vectoriales (CIREV), Instituto Nacional de Investigación en Salud Pública (INSPI), Quito, Ecuador.
Johanna Valentina ArévaloCentro de Investigación en Enfermedades Infecciosas y Vectoriales (CIREV), Instituto Nacional de Investigación en Salud Pública (INSPI), Quito, Ecuador.
Suying LuLunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health, Toronto, Ontario, Canada.
Katariina JaenesLeslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
Yuxiu GuoLeslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
Seray CicekLeslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
Karen ColwillLunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health, Toronto, Ontario, Canada.ORCID 0000-0002-8979-1659
Anne-Claude GingrasLunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health, Toronto, Ontario, Canada.
Rod BremnerLunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health, Toronto, Ontario, Canada.
Patricio PonceCentro de Investigación en Enfermedades Infecciosas y Vectoriales (CIREV), Instituto Nacional de Investigación en Salud Pública (INSPI), Quito, Ecuador.
Keith PardeeLeslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
Varsovia Enid CevallosCentro de Investigación en Enfermedades Infecciosas y Vectoriales (CIREV), Instituto Nacional de Investigación en Salud Pública (INSPI), Quito, Ecuador.ORCID 0000-0001-8666-1536

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The COVID-19 pandemic underscored the critical need to enhance screening capabilities and streamline diagnosis. Point-of-care (POC) tests offer a promising solution by decentralizing testing. We aimed to validate the PLUM device (LSK Technologies Inc.), a portable optical reader, to detect SARS-CoV-2 RNA using direct RT-LAMP targeting the ORF1a and E1 genes and patient antibodies by ELISA. The direct RT-LAMP assays employ nasopharyngeal swabs and bypass RNA extraction protocols through a brief chemical and physical lysis step. Test sensitivity and specificity were assessed against gold-standard detection methods in laboratory and field conditions. For samples with Ct values below 25, direct RT-LAMP showed 83% sensitivity and 90% specificity under laboratory conditions and 91% sensitivity and 92% specificity under field conditions. The nucleocapsid antigen antibody assay had 99% positive percent agreement (PPA) and 97% negative percent agreement (NPA), outperforming spike-RBD antigen (98% PPA, 92% NPA) and seroprevalence (98% PPA, 88% NPA) under laboratory conditions. Under field conditions, similar results were found for antibody detection for the nucleocapsid antigen (93% PPA; 100% NPA), spike-RBD (100% PPA; 94% NPA), and seroprevalence (90% PPA; 94% NPA). This study validated the PLUM device as a dual POC tool for direct RT-LAMP-based SARS-CoV-2 and ELISA-based COVID-19 antibody detection.

Indexed as

Antibodies, ViralCOVID-19SARS-CoV-2COVID-19 TestingCOVID-19 VaccinesEcuadorEnzyme-Linked Immunosorbent AssayHumansMolecular Diagnostic TechniquesNucleic Acid Amplification TechniquesPoint-of-Care SystemsRNA, ViralSensitivity and SpecificityAntibodies, ViralCOVID-19 VaccinesRNA, Viral

Identifiers

PMID40238804
PMCPMC12002511

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.