High performance of a novel point-of-care blood test for <i>Toxoplasma</i> infection in women from diverse regions of Morocco

Mansouri, Bouchra El; Amarir, Fatima; Peyron, François; Adlaoui, El Bachir; Piarroux, Raphaël; Lykins, Joseph; Abbassi, Majda El; Nekkal, Nesma; Bouhlal, Nadia; Makkaoui, Kamar; Barkat, Amina; Lyaghfouri, Aziza; Zhou, Ying; Rais, Samira; Oudghiri, Mounia; Elkoraichi, Ismail; Zekri, Mustapha; Belkadi, Nezha; Mellouk, Hajar; Roubal, M.; Boutajangout, Allal; Sadak, Abderrahim; Limonne, Denis; McLeod, Rima; Bissati, Kamal El

doi:10.1080/22221751.2021.1948359

Cited by 9 publications

(7 citation statements)

References 29 publications

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“…In the Mahinc et al study ([ 26 ], Box 2 and Table 3 ) there were 50 serum samples from 24 women for whom there were 17 samples with IgM only and 33 samples with IgM and IgG; ICT was positive for all samples except one that had a borderline IgM ISAGA of 5 for a patient who later was found to have acute Toxoplasma infection. There were also another 144 acutely infected persons identified in the USA, France, Morocco and Colombia all identified as positive with the ICT [ 24 , 25 , 27 , 29 , 30 ] Box 2 and Table 3 . It was unusual, however, to watch seroconversion with as much precision in narrow time intervals so early in infection as shown in Fig 3C .…”

Section: Resultsmentioning

confidence: 99%

“…Herein, out of 99 IgM false positive sample results, across multiple consecutive different USA and French sets of data recently, there have not been false positives or false negatives using the ICT. In addition, in two countries (the USA and Morocco [ 29 ]), the ICT has not had false positive or borderline bands when testing serum and/or whole blood in the USA and only very rarely in Morocco with whole blood. While it was already known that this test could perform accurately, this present work also has evaluated the ability of ICT to correct the errors of other carefully tested, commercially available screening assays [ 27 ], using prospectively and retrospectively collected sera in the USA, France and Morocco.…”

Section: Discussion (With S1 Commentary )mentioning

confidence: 99%

“…These benefits are amplified in subpopulation demographics in the USA [ 28 ] and regions of the world where the burden of disease is even higher. Examples of this occur in the Lancaster Amish population in the USA [ 8 , 12 , 32 , 46 ], parts of Florida, are likely in other US subpopulations [ 28 ], and occur in Central [ 36 ] and South America [ 47 ], and parts of Africa [ 29 ].…”

Section: Discussion (With S1 Commentary )mentioning

confidence: 99%

“…We collated results of all of our earlier work, both published already [ 23 – 27 , 29 – 31 , 35 ] and other separate studies ongoing at present on related topics that were published separately concurrently [ 30 ], and our current work herein. Our earlier work and some of the work presented herein was used to apply for European CE mark which was granted in October 2020.…”

Section: Methodsmentioning

confidence: 99%

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Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more

Zhou,

Leahy,

Grose

et al. 2024

PLoS Negl Trop Dis

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Background Congenital toxoplasmosis is a treatable, preventable disease, but untreated causes death, prematurity, loss of sight, cognition and motor function, and substantial costs worldwide. Objectives 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. Methods 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. Findings 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. 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 registration NCT04474132, https://clinicaltrials.gov/study/NCT04474132 ClinicalTrials.gov

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Section: Resultsmentioning

confidence: 99%

Section: Discussion (With S1 Commentary )mentioning

confidence: 99%

Section: Discussion (With S1 Commentary )mentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more

Zhou,

Leahy,

Grose

et al. 2024

PLoS Negl Trop Dis

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“…These assays are easily employed in laboratories where infrastructure and skilled lab personnel can be centralized and where patients or study subjects can easily interact with their health system [3]. However, access to these luminescence-based assays is significantly decreased in rural regions, areas populated by nomadic and marginalized groups, or where health infrastructure is non-existent [3,4] and incumbent instruments cannot meet the requirements of these regions. The need for point-of-care assays that can deliver rapid and actionable information that can be applied to management of endemic diseases and emerging infections is becoming increasingly apparent [4][5][6][7].…”

Section: Introductionmentioning

confidence: 99%

A handheld luminometer with sub-attomole limit of detection for distributed applications in global health

Lebel,

Elledge,

Wiener

et al. 2024

PLOS Glob Public Health

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Luminescence is ubiquitous in biology research and medicine. Conceptually simple, the detection of luminescence nonetheless faces technical challenges because relevant signals can exhibit exceptionally low radiant power densities. Although low light detection is well-established in centralized laboratory settings, the cost, size, and environmental requirements of high-performance benchtop luminometers are not compatible with geographically-distributed global health studies or resource-constrained settings. Here we present the design and application of a ~$700 US handheld, battery-powered luminometer with performance on par with high-end benchtop instruments. By pairing robust and inexpensive Silicon Photomultiplier (SiPM) sensors with a low-profile shutter system, our design compensates for sensor non-idealities and thermal drift, achieving a limit of detection of 1.6E-19 moles of firefly luciferase. Using these devices, we performed two pilot cross-sectional serology studies to assess sars-cov-2 antibody levels: a cohort in the United States, as well as a field study in Bangladesh. Results from both studies were consistent with previous work and demonstrate the device’s suitability for distributed applications in global health.

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Building Programs to Eradicate Toxoplasmosis Part IV: Understanding and Development of Public Health Strategies and Advances “Take a Village”

Felín¹,

Wang

Moreira

et al. 2022

Curr Pediatr Rep

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Purpose of Review Review international efforts to build a global public health initiative focused on toxoplasmosis with spillover benefits to save lives, sight, cognition and motor function benefiting maternal and child health. Recent Findings Multiple countries’ efforts to eliminate toxoplasmosis demonstrate progress and context for this review and new work. Summary Problems with potential solutions proposed include accessibility of accurate, inexpensive diagnostic testing, pre-natal screening and facilitating tools, missed and delayed neonatal diagnosis, restricted access, high costs, delays in obtaining medicines emergently, delayed insurance pre-approvals and high medicare copays taking considerable physician time and effort, harmful shortcuts being taken in methods to prepare medicines in settings where access is restricted, reluctance to perform ventriculoperitoneal shunts promptly when needed without recognition of potential benefit, access to resources for care, especially for marginalized populations, and limited use of recent advances in management of neurologic and retinal disease which can lead to good outcomes.

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High performance of a novel point-of-care blood test for Toxoplasma infection in women from diverse regions of Morocco

Abstract: High performance of a novel point-of-care blood test for Toxoplasma infection in women from diverse regions of Morocco

Cited by 9 publications

References 29 publications

Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more

Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more

A handheld luminometer with sub-attomole limit of detection for distributed applications in global health

Building Programs to Eradicate Toxoplasmosis Part IV: Understanding and Development of Public Health Strategies and Advances “Take a Village”

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