Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more.
<h4>Background</h4>Congenital toxoplasmosis is a treatable, preventable disease, but untreated causes death, prematurity, loss of sight, cognition and motor function, and substantial costs worldwide.<h4>Objectives</h4>We asked whether high performance of an Immunochromatograp...
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| Language: | English |
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Public Library of Science (PLoS)
2024-05-01
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| Series: | PLoS Neglected Tropical Diseases |
| Online Access: | https://doi.org/10.1371/journal.pntd.0011335 |
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| author | Ying Zhou Karen Leahy Andrew Grose Joseph Lykins Maryam Siddiqui Nicole Leong Perpetua Goodall Shawn Withers Kevin Ashi Stephen Schrantz Vera Tesic Ana Precy Abeleda Kathleen Beavis Fatima Clouser Mahmoud Ismail Monica Christmas Raphael Piarroux Denis Limonne Emmanuelle Chapey Sylvie Abraham Isabelle Baird Juliette Thibodeau Kenneth M Boyer Elizabeth Torres Shannon Conrey Kanix Wang Mary Allen Staat Nancy Back Coralie L'Ollivier Caroline Mahinc Pierre Flori Jorge Gomez-Marin Francois Peyron Sandrine Houzé Martine Wallon Rima McLeod |
| author_facet | Ying Zhou Karen Leahy Andrew Grose Joseph Lykins Maryam Siddiqui Nicole Leong Perpetua Goodall Shawn Withers Kevin Ashi Stephen Schrantz Vera Tesic Ana Precy Abeleda Kathleen Beavis Fatima Clouser Mahmoud Ismail Monica Christmas Raphael Piarroux Denis Limonne Emmanuelle Chapey Sylvie Abraham Isabelle Baird Juliette Thibodeau Kenneth M Boyer Elizabeth Torres Shannon Conrey Kanix Wang Mary Allen Staat Nancy Back Coralie L'Ollivier Caroline Mahinc Pierre Flori Jorge Gomez-Marin Francois Peyron Sandrine Houzé Martine Wallon Rima McLeod |
| author_sort | Ying Zhou |
| collection | DOAJ |
| description | <h4>Background</h4>Congenital toxoplasmosis is a treatable, preventable disease, but untreated causes death, prematurity, loss of sight, cognition and motor function, and substantial costs worldwide.<h4>Objectives</h4>We 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.<h4>Methods</h4>Data 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.<h4>Findings</h4>ICT 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.<h4>Conclusions/significance</h4>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.<h4>Trial registration</h4>NCT04474132, https://clinicaltrials.gov/study/NCT04474132 ClinicalTrials.gov. |
| format | Article |
| id | doaj-art-30810daaec3a44179b7348fbdd31aa9d |
| institution | Kabale University |
| issn | 1935-2727 1935-2735 |
| language | English |
| publishDate | 2024-05-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Neglected Tropical Diseases |
| spelling | doaj-art-30810daaec3a44179b7348fbdd31aa9d2025-08-20T03:31:52ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352024-05-01185e001133510.1371/journal.pntd.0011335Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more.Ying ZhouKaren LeahyAndrew GroseJoseph LykinsMaryam SiddiquiNicole LeongPerpetua GoodallShawn WithersKevin AshiStephen SchrantzVera TesicAna Precy AbeledaKathleen BeavisFatima ClouserMahmoud IsmailMonica ChristmasRaphael PiarrouxDenis LimonneEmmanuelle ChapeySylvie AbrahamIsabelle BairdJuliette ThibodeauKenneth M BoyerElizabeth TorresShannon ConreyKanix WangMary Allen StaatNancy BackCoralie L'OllivierCaroline MahincPierre FloriJorge Gomez-MarinFrancois PeyronSandrine HouzéMartine WallonRima McLeod<h4>Background</h4>Congenital toxoplasmosis is a treatable, preventable disease, but untreated causes death, prematurity, loss of sight, cognition and motor function, and substantial costs worldwide.<h4>Objectives</h4>We 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.<h4>Methods</h4>Data 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.<h4>Findings</h4>ICT 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.<h4>Conclusions/significance</h4>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.<h4>Trial registration</h4>NCT04474132, https://clinicaltrials.gov/study/NCT04474132 ClinicalTrials.gov.https://doi.org/10.1371/journal.pntd.0011335 |
| spellingShingle | Ying Zhou Karen Leahy Andrew Grose Joseph Lykins Maryam Siddiqui Nicole Leong Perpetua Goodall Shawn Withers Kevin Ashi Stephen Schrantz Vera Tesic Ana Precy Abeleda Kathleen Beavis Fatima Clouser Mahmoud Ismail Monica Christmas Raphael Piarroux Denis Limonne Emmanuelle Chapey Sylvie Abraham Isabelle Baird Juliette Thibodeau Kenneth M Boyer Elizabeth Torres Shannon Conrey Kanix Wang Mary Allen Staat Nancy Back Coralie L'Ollivier Caroline Mahinc Pierre Flori Jorge Gomez-Marin Francois Peyron Sandrine Houzé Martine Wallon Rima McLeod Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more. PLoS Neglected Tropical Diseases |
| title | Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more. |
| title_full | Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more. |
| title_fullStr | Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more. |
| title_full_unstemmed | Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more. |
| title_short | Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more. |
| title_sort | novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more |
| url | https://doi.org/10.1371/journal.pntd.0011335 |
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