Performance of a Toxo IgM prototype assay for the diagnosis of maternal and congenital Toxoplasma infections
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Martine Wallon
,
Hélène Fricker-Hidalgo
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.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Research funding: None declared.
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Employment or leadership: None declared.
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Honorarium: None declared.
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Competing interests: Authors state no conflict of interest.
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Ethical approval: The study protocol was approved by the “Comité de Protection des Personnes” of Lyon.
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©2020 Walter de Gruyter GmbH, Berlin/Boston
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Biotin interference in cardiac troponin immunoassay – where the wild things are?
- Review
- Laboratory-related issues in the measurement of cardiac troponins with highly sensitive assays
- Mini Review
- Chromatographic methods development for clinical practice: requirements and limitations
- Opinion Paper
- Harmonising EQA schemes the next frontier: challenging the status quo
- Genetics and Molecular Diagnostics
- 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
- A novel mitochondrial m.14430A>G (MT-ND6, p.W82R) variant causes complex I deficiency and mitochondrial Leigh syndrome
- Obesity status modifies the association between rs7556897T>C in the intergenic region SLC19A3-CCL20 and blood pressure in French children
- General Clinical Chemistry and Laboratory Medicine
- 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
- Electrophoretic α1-globulin for screening of α1-antitrypsin deficient variants
- A continued method performance monitoring approach for the determination of pediatric renin samples – application within a European clinical trial
- Pilot study for cystic fibrosis neonatal screening: the Cuban experience
- Validation of the analytical performance of the NOVEOS™ System, a system which improves upon the third-generation in vitro allergy testing technology
- IgE cross-reactivity measurement of cashew nut, hazelnut and peanut using a novel IMMULITE inhibition method
- Sexual dimorphism in the cerebrospinal fluid total protein content
- Current state of the morphological assessment of urinary erythrocytes in The Netherlands: a nation-wide questionnaire
- Reference Values and Biological Variations
- Within-subject and between-subject biological variation of first morning void urine amino acids in 12 healthy subjects
- Proenkephalin as a new biomarker for pediatric acute kidney injury – reference values and performance in children under one year of age
- Hematology and Coagulation
- Quality performance for indirect Xa inhibitor monitoring in patients using international external quality data
- Cardiovascular Diseases
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- Short- and long-term biological variation of cardiac troponin I in healthy individuals, and patients with end-stage renal failure requiring haemodialysis or cardiomyopathy
- Infectious Diseases
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- Letters to the Editors
- Evaluation of an ELISA for SARS-CoV-2 antibody testing: clinical performances and correlation with plaque reduction neutralization titer
- Preliminary evaluation of Roche Cobas Elecsys Anti-SARS-CoV-2 chemiluminescence immunoassay
- Hypoalbuminemia and elevated D-dimer in COVID-19 patients: a call for result harmonization
- Total pathway to method validation
- Derivation of performance specifications for uncertainty of serum C-reactive protein measurement according to the Milan model 3 (state of the art)
- FGF23 measurement in burosumab-treated patients: an emerging treatment may induce a new analytical interference
- Use of a modified IDS-ISYS intact PTH assay for intraoperative PTH measurements
- Agreement of dried blood spot lyso-Gb3 concentrations obtained from different laboratories in patients with Fabry disease
- Influence of delayed separation of plasma from whole blood and centrifugation protocol on Zn plasma concentration
- A survey of order of draw on inpatient wards and adherence to EFLM-COLABIOCLI recommendations
- Successful implementations of automated minimum re-test intervals to overcome ferritin over-requesting in a Spanish hospital laboratory
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