Evidence map›Paper›PMID 39093525›Full record

ArticleEuropean journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology2024

Development of a new accurate lateral flow immunoassay for diagnosis of human leptospirosis.

Nazarena Pujato, Juan M Gimenez, Leandro E Peretti, Noelia Y Landolt, Paulina Jacob, Yosena T Chiani, Maria F Schmeling, Iris Miraballes, Norma B Vanasco

Abstract read
PubMed Publisher
In one paragraph

Article in European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 2024. 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. Review
  2. 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

9 authors.

Nazarena PujatoFacultad de Bioquímica y Ciencias Biológicas (FBCB), Universidad Nacional del Litoral (UNL), Ruta Nacional Nº 168, km 472., Santa Fe (CP 3000), Argentina. nazarenapujato@gmail.com.ORCID http://orcid.org/0000-0002-6603-2641
Juan M GimenezFacultad de Bioquímica y Ciencias Biológicas (FBCB), Universidad Nacional del Litoral (UNL), Ruta Nacional Nº 168, km 472., Santa Fe (CP 3000), Argentina.
Leandro E PerettiInstituto de Desarrollo Tecnológico para la Industria Química (INTEC, UNL-CONICET), Santa Fe (CP 3000), Argentina.
Noelia Y LandoltInstituto Nacional de Enfermedades Respiratorias (INER) "Dr. E. Coni", Administración Nacional de Laboratorios e Institutos de Salud (ANLIS) "Dr. Carlos G. Malbrán", Santa Fe (CP 3000), Argentina.
Paulina JacobFacultad de Bioquímica y Ciencias Biológicas (FBCB), Universidad Nacional del Litoral (UNL), Ruta Nacional Nº 168, km 472., Santa Fe (CP 3000), Argentina.
Yosena T ChianiInstituto Nacional de Enfermedades Respiratorias (INER) "Dr. E. Coni", Administración Nacional de Laboratorios e Institutos de Salud (ANLIS) "Dr. Carlos G. Malbrán", Santa Fe (CP 3000), Argentina.
Maria F SchmelingInstituto Nacional de Enfermedades Respiratorias (INER) "Dr. E. Coni", Administración Nacional de Laboratorios e Institutos de Salud (ANLIS) "Dr. Carlos G. Malbrán", Santa Fe (CP 3000), Argentina.
Iris MiraballesInmunología Clínica (BIOCLIN)/Biotecnología (IPTP)-Facultad de Química, Universidad de la República (UdelaR), Montevideo (CP 11800), Uruguay.
Norma B VanascoFacultad de Bioquímica y Ciencias Biológicas (FBCB), Universidad Nacional del Litoral (UNL), Ruta Nacional Nº 168, km 472., Santa Fe (CP 3000), Argentina.

Funding

Administración Nacional de Laboratorios e Institutos de Salud (ANLIS) "Carlos G. Malbrán" FOCANLIS, NRU: 1505Agencia Nacional de Promoción de la Investigación, el Desarrollo Tecnológico y la Innovación (ANPyCT) PICT-2018-03660
6 · The paper itself

Abstract

purposeThe current diagnostic methods for leptospirosis diagnosis are technically complex and expensive, with limited applicability to specialized laboratories. Furthermore, they lack diagnostic accuracy in the acute stage of the disease, which coincides with a period when antibiotics are highly effective. New simple and accurate tests are mandatory to decentralize and improve diagnosis. Here, we introduced a new lateral flow immunoassay (Lepto-LF) for human leptospirosis.

methodsWe conducted a double-blinded assay using 104 serum samples from patients with confirmed or discarded diagnosis for leptospirosis. The diagnostic performance of Lepto-LF was estimated across different ranges of days from onset of symptoms (dpo), considering the diagnostic algorithm as reference standard. Additionally, it was compared with the screening methods enzyme-linked immunosorbent assay (IgM-ELISA) and the slide agglutination test using temperature-resistant antigen (SATR).

resultsLepto-LF exhibited perfect diagnostic performance with a Youden´s index J = 1 from 6 dpo in the acute phase. IgM-ELISA gave slightly lower accuracy with J = 0.91 and 95.5% of both sensitivity and specificity; while SATR showed a markedly inferior yield (J = 0.41, sensitivity = 95.5%, specificity = 45.5%). The performances remained consistent in the convalescence phase of the disease (> 10 dpo).

conclusionLepto-LF was found to be a reliable test for simple, rapid and early diagnosis of leptospirosis, resulting a promising tool for decentralizing leptospirosis diagnosis and enabling timely treatment of patients. In addition, Lepto-LF may be employed as confirmatory test, especially in remote areas and vulnerable contexts where the standard MAT is not available.

Indexed as

Antibodies, BacterialEnzyme-Linked Immunosorbent AssayLeptospirosisSensitivity and SpecificityAdultAgglutination TestsDouble-Blind MethodFemaleHumansImmunoassayImmunoglobulin MLeptospiraMaleMiddle AgedYoung AdultAntibodies, BacterialImmunoglobulin MDiagnostic performanceImmunochromatographyLeptospirosis diagnosisRapid testStrip test

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.