Abstract
Toxoplasmosis is a ubiquitous parasitic infection caused by Toxoplasma gondii (Tg). In immunocompetent people, the infection may be asymptomatic with the induction of an immune response that may prevent reinfection or transmission to the fetus in immune pregnant woman. In immunocompromised persons or seronegative pregnant woman with a primary infection during pregnancy, the infection may result in the loss of life, sight, cognition, and motor function in the immune-compromised person or immunologically immature fetus. The objective of this study was to evaluate a new immunochromatographic test Toxoplasma ICT IgG-IgM (ICT) that allows detection of specific anti-Tg immunoglobulins G (Ig G) and M (Ig M). We included 1145 prospectively obtained sera and 376 samples selected for specificity or sensitivity studies. The performance of ICT was compared using Vidas® Toxo Competition (TXC) and Toxoscreen®. In case of discrepancy, Vidas® Toxo Ig G or Ig M and LDBIO Toxo II IgG western blot were used to establish definitive results by additional methods. Sensitivity and specificity of ICT were respectively 99.3% and 100%. In comparison, Toxoscreen®’s sensitivity was 100% and the specificity was 99.8%. TXC had a sensitivity of 98.7% with a specificity of 99.1%. ICT has excellent performance even for low Ig G titers, especially in immunocompromised patients, and confirms the specificity of isolated Ig M. This ICT provides reliable results easily and quickly. This screening technique is not designed to differentiate the Ig M from Ig G. When positive, additional tests may be necessary.
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Data availability
The datasets generated during the current study are not publicly available due to associated clinical data but are available from the corresponding author on reasonable request.
Code availability
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Acknowledgements
We thank the Taking out Toxo, the Network for Good, the Toxoplasmosis Research Institute, the Cornwell Mann Family Foundation, and the Morel and Rodriguez families for their support of the Toxoplasmosis Research Laboratory work in Chicago during the time these studies were planned, developed and carried out.
Funding
We thank The Thrasher Children’s Charity Research Fund for their E.W. “Al” Thrasher Award, the Susan and Richard Kiphart Family Foundation Global–Local Health Seed Fund Award (to RMc), the LDBio Diagnostics that supplied the ICT, Toxoscreen®, and TXC reagents and paid for an additional technician to perform the tests within the Bichat Hospital laboratory. They did not interfere with the performing of the tests, the recording and interpretation of the results nor the reported conclusions.
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Sylvie Abraham, Rima McLeod, and Sandrine Houzé conceived and designed the study. Sylvie Abraham performed the laboratory experiments. Sandrine Houzé brought technical support and result validation. Statistical analysis was performed by Sylvie Abraham and Raphael Piarroux. The first draft of the manuscript was written by Sylvie Abraham and all authors commented on the previous versions of the manuscript. All authors read and approved the final manuscript.
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The USA sending was exempted by University of Chicago investigational research board as it was impossible to link samples to patients and residual samples that are otherwise discarded were utilized. For French samples, only the staffs from the hospital had access to the laboratory results. Interpretation was performed anonymously. According to the French law, patients were informed that their samples might be used for research and they retained the right to oppose the use of their anonymized medical data for research purpose. Dedicated ethical approval and individual patient consent were not necessary for this type of research.
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Competing interests
In Paris and Lyon, the authors in Paris and Lyon have no relevant financial or non-financial interests to disclose except R Piarroux who was employed by the LDBio Company. In Chicago, at LDBio Diagnostics, Raphael Piarroux PharmD, PhD (RP) was the R&D Director Scientist until January 13, 2023, and during that time these studies were planned and discussed with RMc Leod (RMc). A patent application was submitted by D. Limonne, PharmD with the scientists at the University of Chicago and in Lyon, France in August 2018. This application is pending review in the United States Patent Office in accordance with the US Bayh Dole laws. This is for the development of the whole blood point of care test and the practical clinical utility of the ICT to guide treatment for gestational infection to prevent congenital toxoplasmosis. This is to insure its continued high-quality performance and reproducibility of the results described herein. In this collaborative work, the scientist RP and DL at LDBio provided insights and knowledge from their earlier work in creating the ICT. The scientists at LDBio did not interfere with the obtaining of samples, performing of the tests, the recording and interpretation of the results, nor the reported conclusions of any work at any academic site. All this work was performed independently in the academic centers. There was no payment to those at the University of Chicago.
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Abraham, S., Piarroux, R., Zhou, Y. et al. Performances of ICT Toxoplasma IgG-IgM test in comparison with Vidas® toxo competition to determine the immune status against Toxoplasma gondii. Eur J Clin Microbiol Infect Dis 42, 1327–1335 (2023). https://doi.org/10.1007/s10096-023-04669-8
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DOI: https://doi.org/10.1007/s10096-023-04669-8