Molecular CMV assay
DiaSorin has further expanded its range of infectious disease assays for use on the DiaSorin Liaison Iam analyser with the launch of a new molecular assay for the rapid and reliable detection and quantification of cytomegalovirus (CMV). CMV is the most prevalent infectious pathogen in solid organ and bone marrow transplant recipients, and can lead to allograft rejection and other serious complications. The DiaSorin Iam CMV assay is used to detect and quantify clinically relevant subtypes of CMV in human plasma, urine and cerebrospinal fluid (CSF), making it a valuable tool for the diagnosis and monitoring of CMV infection in transplant recipients and other immunocompromised individuals. Reactivation of latent CMV infection can occur in immunocompromised individuals. With increasing numbers of transplant recipients, as well as expanding indications for immune-modulating agents, the number of people at risk of CMV disease and related complications is increasing. The direct and indirect effects of CMV infection can have a significant impact on outcomes for transplant recipients. Furthermore, CMV is a major cause of morbidity in AIDS patients and in others with impaired immunity, for example due to sarcoidosis, lymphoma and corticosteroid therapy. Clinical manifestations amongst these patient groups include retinitis, pneumonitis, gastrointestinal disease and neurological disorders. Based on the innovative DiaSorin Q-LAMP technology, Iam CMV is the latest addition to an expanding portfolio of infectious disease assays for use on the DiaSorin Liaison Iam analyser. It is a molecular assay for the detection of CMV in human amniotic fluid and for the detection and quantification of the virus in human plasma, urine and cerebrospinal fluid (CSF). Iam CMV has been standardized against the WHO CMV International Standard (NIBSC, UK), as recommended in the updated International Consensus Guidelines on the Management of Cytomegalovirus in Solid Organ Transplantation. With excellent intra-run precision (≤ 0.3 log cps/mL) and with diagnostic sensitivity (≥97%) and specificity (100%) comparable to conventional PCR, but with results in a fraction of the time required by PCR, Iam CMV provides a rapid and accurate method for the timely diagnosis and monitoring of CMV infection. The small footprint, ease of use and scalable design of the benchtop Liaison Iam Molecular Instrument makes it ideal for use in laboratory facilities of all sizes, including those that are located close to the patient. In addition to being used for the detection and monitoring of CMV infection in immunocompromised individuals, Iam CMV is also used in the diagnosis of maternal and fetal CMV infection in early pregnancy and for monitoring CMV infection in affected babies. The Iam CMV assay is CE marked and available for use outside of the USA and Canada.
