Evidence map›Paper›PMID 39716196›Full record

ArticleParasites & vectors2024

Evaluation of novel recombinant antigen-based (NIE/SsIR) immunochromatographic rapid tests for Strongyloides stercoralis: an accuracy study.

Salvatore Scarso, Francesca Tamarozzi, Cristina Mazzi, Monica Degani, Eleonora Rizzi, Stefano Tais, Dora Buonfrate

Abstract readEvaluation Study
In one paragraph

Article in Parasites & vectors, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

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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

7 authors.

Salvatore ScarsoDepartment of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.
Francesca TamarozziDepartment of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.
Cristina MazziClinical Research Unit, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.
Monica DeganiDepartment of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.
Eleonora RizziDepartment of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.
Stefano TaisDepartment of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy.
Dora BuonfrateDepartment of Infectious Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy. dora.buonfrate@sacrocuore.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStrongyloidiasis is a chronic parasitic disease that results in relevant human morbidity, caused by the nematode Strongyloides stercoralis. This nematode has a unique and complex life-cycle. There is so far no perfect test for this helminthiasis. Rapid immunochromatographic tests (RDTs) are of interest, specifically due to their feasibility for use in the field, where public health control of strongyloidiasis is recommended. The aim of this study was to evaluate two novel RDTs, one detecting immunoglobulin (Ig) G and the other detecting IgG4, based on a combination of recombinant antigens. The primary objective was to estimate the sensitivity and specificity of these RDTs, and the secondary objective was to assess ease of interpretation.

methodsSerum samples stored in our biobank with available matched results for at least one fecal (i.e. agar plate culture or PCR) and one serology test (i.e. enzyme-linked immunosorbent assay [ELISA] or indirect immunofluorescent antibody test [IFAT]) for S. stercoralis, were selected for this study. Those with at least one positive result for the fecal test were considered to be true positives (irrespective of the serology), while true negatives were those with negative results for both the fecal and serology tests. The results of the RDTs were read independently by two laboratory technicians. When disagreement over the results occurred, a third reader was involved, and the final result for each test was based on consistent results from two readers. Estimates were reported along with the 95% confidence intervals (CI). Regarding the secondary objective, agreement between two independent readers was calculated with Cohen's kappa statistic (κ).

resultsA total of 90 serum samples were tested. Sensitivity of the IgG- and the IgG4-RDTs was 91.1% (95% CI 78.8-97.5) and 77.3% (95% CI 62.2-88.5), respectively. Specificity was 91.1% (95% CI 78.8-97.5) for the IgG-RDT and 100% (95% CI 92.1-100) for the IgG4-RDT. Agreement between readers was excellent (Cohen's κ = 0.96, 95% CI 0.86-1.08%).

conclusionsThe IgG-RDT demonstrated higher sensitivity and could hence be preferred for individual diagnosis, whereas the excellent specificity of the IgG4-RDT could be preferred for prevalence surveys in endemic areas. The results of both RDTs were easy to interpret based on excellent agreement between readers. Large prospective studies should follow to confirm these findings and to validate the use of either RDT for specific purposes/contexts.

Indexed as

Antibodies, HelminthAntigens, HelminthChromatography, AffinityImmunoglobulin GSensitivity and SpecificityStrongyloides stercoralisStrongyloidiasisAdultAnimalsEnzyme-Linked Immunosorbent AssayFecesFemaleHumansMaleMiddle AgedRecombinant ProteinsAntibodies, HelminthAntigens, HelminthImmunoglobulin GRecombinant ProteinsDiagnosisImmunochromatographicRapid testStrongyloidesStrongyloidiasis

Identifiers

PMID39716196
PMCPMC11668118

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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.