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Performance of a Toxo IgM prototype assay for the diagnosis of maternal and congenital Toxoplasma infections

  • Martine Wallon EMAIL logo , Hélène Fricker-Hidalgo , Emmanuelle Chapey , Claire Bailet , Céline Dard , Marie-Pierre Brenier-Pinchart and Hervé Pelloux
Published/Copyright: April 24, 2020
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 58 Issue 11

Abstract

Background

Testing for anti-Toxoplasma immunoglobulin (Ig)M is of main importance in the context of pregnancy to promptly alert to an acute maternal infection prior to the detection of IgG and to identify infected newborns. Their absence helps exclude a recent maternal infection in the presence of IgG.

Methods

The performance of a Toxo IgM immunocapture prototype assay (bioMérieux, France) was compared with that of the VIDAS® Toxo IgM and the ARCHITECT® Toxo IgM (Abbott, Germany) assays at Grenoble and Lyon (France). A total of 1446 sera were sampled from (i) 1054 pregnant women found by routine workup to have no infection (n = 843), an acute infection (<4 months) (n = 28) or a chronic infection (>4 months) with residual (n = 120) or no IgM (n = 62); (ii) 50 three-serum panels sampled immediately after a maternal seroconversion; (iii) 242 samples taken in 41 children with a congenital toxoplasmosis (n = 122) and in 40 uninfected children (n = 120).

Results

In pregnant women, the overall agreement with the VIDAS® assay was 99.23% (CI: 99.16–99.27) and that with the ARCHITECT® assay was 99.14% (CI: 99.07–99.17). Sensitivity of the Toxo IgM prototype assay was 100% (CI: 87.66–100.00) and specificity was 99.64% (98.96–99.93). In acute maternal infections, IgM assays were detected as early with the prototype as with the other two. In the congenitally infected children, IgM were detected on their first sample in 25/40 with the prototype vs. 23/40 with the VIDAS® test. No uninfected child had positive IgM.

Conclusion

The prototype performed comparably to the ARCHITECT® and VIDAS® Toxo IgM assays for the diagnosis of maternal and congenital toxoplasmosis.

Keywords: antibody; congenital, IgM; pregnancy; serology; Toxoplasma gondii ; toxoplasmosis
Corresponding author: Martine Wallon, Service de Parasitologie et de Mycologie Médicale, Hôpital de la Croix Rousse, CHU de Lyon, Lyon, France; and Faculté de Médecine Lyon-Sud, Waking Team, Centre de Recherche en Neurosciences de Lyon, INSERM U1028-CNRS UMR 5292, Université Claude Bernard Lyon 1, Lyon, France

  1. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: Authors state no conflict of interest.

  6. Ethical approval: The study protocol was approved by the “Comité de Protection des Personnes” of Lyon.

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Received: 2019-11-20
Accepted: 2020-03-26
Published Online: 2020-04-24
Published in Print: 2020-10-25

©2020 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2019-1199
Keywords for this article
antibody; congenital, IgM; pregnancy; serology; Toxoplasma gondii; toxoplasmosis

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Biotin interference in cardiac troponin immunoassay – where the wild things are?
  4. Review
  5. Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays
  6. Mini Review
  7. Chromatographic methods development for clinical practice: requirements and limitations
  8. Opinion Paper
  9. Harmonising EQA schemes the next frontier: challenging the status quo
  10. Genetics and Molecular Diagnostics
  11. Direct comparison study between droplet digital PCR and a combination of allele-specific PCR, asymmetric rapid PCR and melting curve analysis for the detection of BRAF V600E mutation in plasma from melanoma patients
  12. A novel mitochondrial m.14430A>G (MT-ND6, p.W82R) variant causes complex I deficiency and mitochondrial Leigh syndrome
  13. Obesity status modifies the association between rs7556897T>C in the intergenic region SLC19A3-CCL20 and blood pressure in French children
  14. General Clinical Chemistry and Laboratory Medicine
  15. Influence of reagent lots and multiple measuring systems on estimating the coefficient of variation from quality control data; implications for uncertainty estimation and interpretation of QC results
  16. Electrophoretic α1-globulin for screening of α1-antitrypsin deficient variants
  17. A continued method performance monitoring approach for the determination of pediatric renin samples – application within a European clinical trial
  18. Pilot study for cystic fibrosis neonatal screening: the Cuban experience
  19. Validation of the analytical performance of the NOVEOS™ System, a system which improves upon the third-generation in vitro allergy testing technology
  20. IgE cross-reactivity measurement of cashew nut, hazelnut and peanut using a novel IMMULITE inhibition method
  21. Sexual dimorphism in the cerebrospinal fluid total protein content
  22. Current state of the morphological assessment of urinary erythrocytes in The Netherlands: a nation-wide questionnaire
  23. Reference Values and Biological Variations
  24. Within-subject and between-subject biological variation of first morning void urine amino acids in 12 healthy subjects
  25. Proenkephalin as a new biomarker for pediatric acute kidney injury – reference values and performance in children under one year of age
  26. Hematology and Coagulation
  27. Quality performance for indirect Xa inhibitor monitoring in patients using international external quality data
  28. Cardiovascular Diseases
  29. Clinical risk assessment of biotin interference with a high-sensitivity cardiac troponin T assay
  30. Short- and long-term biological variation of cardiac troponin I in healthy individuals, and patients with end-stage renal failure requiring haemodialysis or cardiomyopathy
  31. Infectious Diseases
  32. Monocyte distribution width (MDW) as a screening tool for sepsis in the Emergency Department
  33. Performance of a Toxo IgM prototype assay for the diagnosis of maternal and congenital Toxoplasma infections
  34. Letters to the Editors
  35. Evaluation of an ELISA for SARS-CoV-2 antibody testing: clinical performances and correlation with plaque reduction neutralization titer
  36. Preliminary evaluation of Roche Cobas Elecsys Anti-SARS-CoV-2 chemiluminescence immunoassay
  37. Hypoalbuminemia and elevated D-dimer in COVID-19 patients: a call for result harmonization
  38. Total pathway to method validation
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  40. FGF23 measurement in burosumab-treated patients: an emerging treatment may induce a new analytical interference
  41. Use of a modified IDS-ISYS intact PTH assay for intraoperative PTH measurements
  42. Agreement of dried blood spot lyso-Gb3 concentrations obtained from different laboratories in patients with Fabry disease
  43. Influence of delayed separation of plasma from whole blood and centrifugation protocol on Zn plasma concentration
  44. A survey of order of draw on inpatient wards and adherence to EFLM-COLABIOCLI recommendations
  45. Successful implementations of automated minimum re-test intervals to overcome ferritin over-requesting in a Spanish hospital laboratory
  46. Remarkable pseudoleucocytosis induced by mild cryoglobulinemia
  47. Massive hemolysis due to Clostridium perfringens: a laboratory’s perspective
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