INFEZIONE PRIMARIA PRECONCEZIONALE DA CITOMEGALOVIRUS UMANO E RISCHIO DI INFEZIONE CONGENITA.

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Clinical evaluation of the Roche Elecsys\uae CMV IgG Avidity assay

Congenital cytomegalovirus (CMV) infection has potentially severe consequences in newborns. The testing of pregnant women for CMV-specific antibodies may be useful for the identification of women at risk of transmitting the infection to the fetus. The determination of CMV IgG avidity helps to establish the timing of infection as IgG avidity matures during the course of infection. This study examines the performance of the Elecsys CMV IgG Avidity assay using preselected samples from patients at different phases of CMV infection. The Elecsys CMV IgG Avidity assay was tested at three sites using sequential samples from patients with recent primary CMV infection, as well as single samples from patients with recent primary or past CMV infection. The Elecsys assay discriminated well between early (low avidity) and late (high avidity) phases of infection in sequential serum samples. Overall, 98.8% of low-avidity samples corresponded to infection onset 90 days before sampling. The assay's sensitivity was 90-97%, with specificity ranging from 89 to 100%, depending on the consideration of gray-zone avidity values. Single samples from recent primary or past infection showed similar distributions of avidity results. The Elecsys CMV IgG Avidity assay results are in agreement with preselected samples from patients with primary or past CMV infection, showing that the test is an adequate predictor of the phase of infection

Diagnosis and monitoring of human cytomegalovirus infection in transplant recipients

In the last decade, transplantology has become the treatment of choice for a large number of malignant diseases or organ dysfunctions. Transplants are classi®ed into two main groups: solid organ transplants (SOT) and haematopoietic stem cell transplants (HSCT). Human cytomegalovirus (HCMV) infection is the most common viral complication in both SOT and HSCT recipients within 3 months of transplant. Major risk factors for HCMV infection are the mismatch between donor and recipient antibody status, and the immunosuppressive regimen. Clinical manifestations range from asymptomatic infections to severe HCMV disease involving lung, gastrointestinal tract, liver, retina, central and peripheral nervous systems. Diagnosis is based mainly upon detection and quanti®cation of virus in blood by determination of viraemia, antigenaemia, DNAaemia, and RNAaemia. In addition, detection of the emergence of resistance to HCMV-speci®c antiviral drugs such as ganciclovir and foscarnet, may be achieved by performing phenotypic and genotypic assays. Monitoring of HCMV infections in both SOT and HSCT recipients allows timely adoption of pre-emptive (presymptomatic) therapy strategies, which have led to almost complete disappearance of HCMV disease in both transplantation settings. In parallel, sustained treatment with speci®c antiviral drugs must elicit monitoring of antiviral drug resistance to permit a timely shift to an alternative drug. In conclusion, diagnostic and therapeutic tools now available allow almost complete control of HCMV infections in different ransplantation settings

DNAEMIA VS PP65-ANTIGENEMIA PER LA GUIDA DELLA TERAPIA PRESINTOMATICA DELL'INFEZIONE DA CITOMEGALOVIRUS IN TRAPIANTATI D'ORGANO.

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Clinical evaluation of new automated cytomegalovirus IgM and IgG assays for the Elecsys(\uae) analyser platform.

Cytomegalovirus (CMV) is a leading cause of physical and neurological abnormalities in newborns. Hence, the diagnosis of CMV infection in pregnant women is necessary in order to allow appropriate management of their pregnancy. New assays have been developed for the Roche Elecsys\uae immunoassay platform that detect CMVspecific immunoglobulin (Ig)M and IgG, with the IgM assay designed to target IgM produced at the start of infection rather than IgM persisting later in infection. This study aimed to evaluate the performance of the new assays compared with other commercial kits widely distributed in laboratories. The performance of the Elecsys and comparator CMV IgM and IgG assays was assessed using 967 preselected patient samples characterised by CMV infection status, as well as being compared using 1,668 unselected clinical samples. The Elecsys CMV IgM and IgG assays performed consistently with comparator assays using the preselected samples. The Elecsys CMV IgM assay showed improved sensitivity compared with the Enzygnost\uae assay in primary infection (91.2 % vs. 79.4 %) and improved specificity over the Architect\uae assay in potentially crossreacting samples (94.1 % vs. 82.4 %). The Elecsys IgM assay reported fewer positive results in the later stages of CMV infection compared with ETI-CYTOK-M ELISA, while the Elecsys IgG assay reported slightly fewer negative results in the early stages of infection compared with ETICYTOK- G ELISA. There was good agreement between Elecsys and comparator assays using unselected clinical samples (range 90.4\u201399.4 %). The Elecsys CMV IgM and IgG assays compare well with routinely used assays and are suitable for clinical use