Multicenter evaluation of the Real-TM (Sacace) kit performance for the molecular diagnosis of toxoplasmosis.

The molecular detection of DNA is a key tool for the diagnosis of disseminated and congenital toxoplasmosis. This multicentric study from the Molecular Biology Pole of the French National Reference Center for toxoplasmosis aimed to evaluate Real-TM PCR kit (Sacace). The study compared the analytical and clinical performances of this PCR assay with the reference PCRs used in proficient laboratories.

Comparative performance of ISAGA IgM and ELISA assays for the diagnosis of maternal and congenital Toxoplasma infections: which technique could replace ISAGA IgM?

The ISAGA immunocapture test for the detection of anti-Toxoplasma immunoglobulin M is a manual technique known for its excellent sensitivity and specificity. The purpose of this retrospective, multicenter study was to compare the performances and agreement between ISAGA and other IgM detection techniques before cessation of ISAGA production. The analytic performance of the different tests was evaluated using 1,341 serum samples from adults with positive IgM and negative IgG to Toxoplasma gondii, and 1,206 sera from neonates born to mothers with seroconversion.

Can precision medicine be integrated into routine therapeutic decisions at the bedside of patients?

Therapeutic strategies are shifting from a "one-size-fits-all" population-based approach to a stratified approach targeting groups with similar characteristics, or even individuals, tailoring treatments to the unique characteristics of each patient. Since such strategies rely on increasingly complex knowledge and healthcare technologies, along with an understanding of the tools of precision medicine, the appropriate dissemination and use of these strategies involves a number of challenges for the medical community. Having evaluation methodologies that have been jointly designed with the institutional, industrial, academic stakeholders, and also patients, like streamlining the processes and externally validating performances, could enhance the relevance of the "evaluation" aspect of precision medicine.

Length of stay in at-risk areas and time to malaria attack on return.

Background: Experimental infection with Plasmodium falciparum results in malaria attack within a few days of exposure. However, we have regularly observed malaria attack within a short time after return, regardless of the time spent in an endemic area. We therefore aimed to assess whether the time before return and malaria attack varies according to length of stay.

Contribution of serology in congenital toxoplasmosis diagnosis: results from a 10-year French retrospective study.

This study aimed to evaluate different serological strategies for the postnatal diagnosis of congenital toxoplasmosis (CT) and establish a biological algorithm for CT diagnosis. The study analyzed serological data of immunoglobulins M, A, and G (IgM, IgA, IgG) performed by immunoenzymatic and compared immunological profile (CIP) assays in 668 newborns with CT diagnosis across four testing periods: P1 (D0- D10), P2 (D11-D35), P3 (D36-D45), and P4 (>D45). Forty-nine percent of the 668 CT cases were diagnosed during P1 and 34%, 4%, and 12% during P2, P3, and P4, respectively.

IgM triplet in neonatal diagnosis by immunoblotting and its potential use as a diagnostic marker for congenital toxoplasmosis.

Primary infection during pregnancy by the protozoan Toxoplasma gondii can be worrisome because transmission to the fetus may lead to congenital toxoplasmosis (CT). Neonatal diagnosis is usually performed by serological profile comparison of the mother and newborn. As previously reported in 2012 by C.

Serological diagnosis of toxoplasmosis: evaluation of the commercial test recomLine Toxoplasma IgG immunoblot (Mikrogen) based on recombinant antigens.

Background: IgG detection to determine immune status to Toxoplasma gondii infection and seroconversion mainly relies on ELISA techniques and, if necessary, on a confirmatory test, Western blot. This study evaluated the performance of the recomLine Toxoplasma IgG immunoblot (IB-recomLine) (Mikrogen) as a confirmatory test on a large number of sera. A total of 171 sera were selected (113 patients) and had previously been analyzed by two ELISA tests, ARCHITECT (Abbott) and VIDAS (bioMérieux) ± LDBIO-Toxo II IgG Western blot (WB-LDBIO) (LDBio).

Diagnostic Accuracy of LDBIO-Toxo II IgG and IgM Western Blot in Suspected Seroconversion in Pregnancy: A Multicentre Study.

The high sensitivity of the automated tests used for serology can yield false-positive IgM results due to aspecific reactions. On the other hand, specific therapy can delay IgG production and, therefore, the diagnosis of seroconversion. There is a need for confirmation tests to early detect seroconversions during pregnancy.

Molecular Diagnosis of Toxoplasmosis: Multicenter Evaluation of the Toxoplasma RealCycler Universal PCR Assay on 168 Characterized Human Samples.

Real-time PCR plays a crucial role in the diagnosis of toxoplasmosis. In this multicenter study, the Toxoplasma RealCycler Universal assay was assessed for the diagnosis of toxoplasmosis by eight reference laboratories. DNAs from diverse clinical samples were included: 141 characterized samples from patients with different clinical forms of proven toxoplasmosis and 27 from patients without toxoplasmosis were tested in duplicate with the commercial assay.

Molecular diagnosis of toxoplasmosis: recent advances and a look to the future.

Introduction: Toxoplasmosis is a globally distributed parasitic infection that can be particularly severe when opportunistic or congenital. Its diagnosis requires accurate and rapid techniques that rely mainly on serology and molecular methods.

Areas Covered: The aim of this review was to discuss the positioning of the molecular diagnosis of toxoplasmosis according to the different clinical situations possibly resulting from infection with , and to detail recent developments in this technique.

Multicenter Comparative Assessment of the TIB MolBiol Toxoplasma gondii Detection Kit and Four Laboratory-Developed PCR Assays for Molecular Diagnosis of Toxoplasmosis.

Toxoplasmosis can be a life-threatening infection, particularly during pregnancy and in immunocompromised patients. The biological diagnosis of toxoplasmosis is challenging and has been revolutionized by molecular detection methods. This article summarizes the data of a multicenter study involving four centers to assess the performances of a commercial PCR assay as compared with four in-house PCR assays using Toxoplasma gondii standards, 20 external quality control specimens, and 133 clinical samples.

Impact of pre-analytic step duration on molecular diagnosis of toxoplasmosis for five types of biological samples.

Introduction: Toxoplasma-PCR is essential to diagnose ocular, cerebral, disseminated and congenital toxoplasmosis. This multicenter study evaluated the impact of sample storage duration at +4°C on PCR assay performances in order to propose guidelines for the storage of samples during shipment or/and before PCR.

Materials And Methods: Five matrices, amniotic (AF), cerebrospinal (CSF), and bronchoalveolar lavage fluids (BALF), whole blood (WB) and buffy coat (BC), were artificially spiked with different amounts of Toxoplasma gondii (20, 100, 500 tachyzoites per mL of sample) or with previously infected THP1 cells.

A brain cyst load-associated antigen is a Toxoplasma gondii biomarker for serodetection of persistent parasites and chronic infection.

Background: Biomarker discovery remains a major challenge for predictive medicine, in particular, in the context of chronic diseases. This is true for the widespread protozoan Toxoplasma gondii which establishes long-lasting parasitism in metazoans, humans included. This microbe successively unfolds distinct genetic programs that direct the transition from high to low replicative potential inside host cells.

Serology for Toxoplasma in Immunocompromised Patients: Still Useful?

Toxoplasmosis represents one of the most common comorbidity factors in solid organ or hematopoietic stem cell transplant recipients as well as in other immunocompromised patients. In the past decades, availability and performance of molecular tools for the diagnosis or the exclusion of toxoplasmosis in these patients have greatly improved. However, if accurately used, serology remains a complementary and essential diagnostic tool for physicians and medical parasitologists for the prevention and management of toxoplasmosis in immunocompromised patients as well.

Prospective study of serum and aqueous humour anti-Hsp70.1 IgG antibody levels in ocular toxoplasmosis.

Aims: We evaluate whether the serum and aqueous humour (AH) level of IgG anti-Hsp70.1 antibodies improved the biological diagnosis of ocular toxoplasmosis.

Methods And Results: In this prospective cross-sectional and multicentre study, serum and AH were collected at the time of active uveitis.

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

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).

How to estimate time of infection with Toxoplasma gondii in pregnant women. Use of specific IgG and IgM kinetics by 7 techniques on 691 sera.

A difficulty when detecting both anti-Toxoplasma gondii-specific IgG and IgM in pregnant women is estimating the date of infection. The aim of this study was to compare the anti-Toxoplasma-specific immunoglobulin kinetics of 7 serological techniques to date the infection and to draw kinetic curves that are easy to use on a daily basis. IgG and IgM antibodies were measured on 691 sera samples.

Hypereosinophilia: Biological investigations and etiologies in a French metropolitan university hospital, and proposed approach for diagnostic evaluation.

Objectives: We aimed to evaluate the usefulness of biological investigations in cases of eosinophilia in our area (French Alps).

Methods: We retrospectively included all adult patients attending the infectious disease and internal medicine units between 2009 and 2015 with eosinophilia ≥1 G/l.

Results: We identified 298 cases (129 women and 169 men).

Toxoplasmosis in Transplant Recipients, Europe, 2010-2014.

Transplantation activity is increasing, leading to a growing number of patients at risk for toxoplasmosis. We reviewed toxoplasmosis prevention practices, prevalence, and outcomes for hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT; heart, kidney, or liver) patients in Europe. We collected electronic data on the transplant population and prevention guidelines/regulations and clinical data on toxoplasmosis cases diagnosed during 2010-2014.

Management of toxoplasmosis in transplant recipients: an update.

Toxoplasmosis is a life-threatening parasitic disease for hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients. The risk of toxoplasmosis in transplant patients mainly depends on the degree of immunosuppression, the tropism of Toxoplasma gondii for the grafted tissue, and the seroprevalence in the general population. Although transplant recipients with toxoplasmosis have a high mortality rate, there are neither well-defined recommendations nor a consensus for the management of this disease in these patients.

Serodiagnosis of Extraintestinal Amebiasis: Retrospective Evaluation of the Diagnostic Performance of the Bordier® ELISA Kit.

Soluble antigens from an axenic culture of were used to develop a commercial ELISA kit to quantify anti- antibodies in sera of patients with extraintestinal amebiasis in non-endemic settings. The diagnostic specificity and sensitivity of the test were assessed retrospectively using 131 human serum samples with amoebic serologic status available. They were selected according to their results in immunofluorescence (IFAT) and were separated in 2 sample categories: 64 sera with positive results by IFAT and 67 with negative results by IFAT.