Trial reportPLoS neglected tropical diseases2024
Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more.
Trial report in PLoS neglected tropical diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04474132 (Feasibility Study for Finger Prick Testing of Presence of Current and or Previous T. Gondii Infection), which is not on this map. Cited by 6 papers.
What it found
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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.
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.
Feasibility Study for Finger Prick Testing of Presence of Current and or Previous T. Gondii Infection
Who cites it
6 citing papers in PubMed.
- Using dried blood spots to estimate Toxoplasma gondii seroprevalence in pregnant women in Catalonia, Spain, and to serologically diagnose congenital toxoplasmosis.PLoS neglected tropical diseases · 2026Article
- A Systematic Review and Meta-Analysis of Diagnostic Test Accuracy for Human Toxoplasmosis: Performance, Populations, and Validation Gaps.Medical devices (Auckland, N.Z.) · 2026Review
- Fatal Congenital Toxoplasmosis with Progressive Liver Failure and Genomic Characterization of a Novel Isolate from the United States.Microorganisms · 2025Article
- Epidemiological changes in Toxoplasma infection: a 7-year longitudinal study in pregnant women in Lyon, France, 2017-2023.Parasite (Paris, France) · 2025Article
- REIV-TOXO Project: Results from a Spanish cohort of congenital toxoplasmosis (2015-2022). The beneficial effects of prenatal treatment on clinical outcomes of infected newborns.PLoS neglected tropical diseases · 2024Observational
- MaternalFrontiers in cellular neuroscience · 2023Article
Corrections and comments
- Update of
Authors and funding
36 authors.
Funding
Abstract
backgroundCongenital toxoplasmosis is a treatable, preventable disease, but untreated causes death, prematurity, loss of sight, cognition and motor function, and substantial costs worldwide.
objectivesWe asked whether high performance of an Immunochromatographic-test (ICT) could enable accurate, rapid diagnosis/treatment, establishing new, improved care-paradigms at point-of-care and clinical laboratory.
methodsData were obtained in 12 studies/analyses addressing: 1-feasibility/efficacy; 2-false-positives; 3-acceptability; 4-pink/black-line/all studies; 5-time/cost; 6-Quick-Information/Limit-of-detection; 7, 8-acute;-chronic; 9-epidemiology; 10-ADBio; 11,12-Commentary/Cases/Chronology.
findingsICT was compared with gold-standard or predicate-tests. Overall, ICT performance for 1093 blood/4967 sera was 99.2%/97.5% sensitive and 99.0%/99.7% specific. However, in clinical trial, FDA-cleared-predicate tests initially caused practical, costly problems due to false-positive-IgM results. For 58 persons, 3/43 seronegative and 2/15 chronically infected persons had false positive IgM predicate tests. This caused substantial anxiety, concerns, and required costly, delayed confirmation in reference centers. Absence of false positive ICT results contributes to solutions: Lyon and Paris France and USA Reference laboratories frequently receive sera with erroneously positive local laboratory IgM results impeding patient care. Therefore, thirty-two such sera referred to Lyon's Reference laboratory were ICT-tested. We collated these with other earlier/ongoing results: 132 of 137 USA or French persons had false-positive local laboratory IgM results identified correctly as negative by ICT. Five false positive ICT results in Tunisia and Marseille, France, emphasize need to confirm positive ICT results with Sabin-Feldman-Dye-test or western blot. Separate studies demonstrated high performance in detecting acute infections, meeting FDA, CLIA, WHO REASSURED, CEMark criteria and patient and physician satisfaction with monthly-gestational-ICT-screening. CONCLUSIONS/SIGNIFICANCE: This novel paradigm using ICT identifies likely false positives or raises suspicion that a result is truly positive, rapidly needing prompt follow up and treatment. Thus, ICT enables well-accepted gestational screening programs that facilitate rapid treatment saving lives, sight, cognition and motor function. This reduces anxiety, delays, work, and cost at point-of-care and clinical laboratories.
trial registrationNCT04474132, https://clinicaltrials.gov/study/NCT04474132 ClinicalTrials.gov.
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