For in vitro diagnostic use. RIDA®GENE CMV is a real-time PCR for the direct qualitative and quantitative detection of cytomegalovirus in human plasma specimens (EDTA) (quantitative) and urine (qualitative).
The human cytomegalovirus (HCMV) is one of the human herpesviruses (Human herpesvirus 5). CMV occurs in humans and a number of animals; however, the virus of one species is not transmissible to another species. There is only one serotype in the HCMV group, but there are numerous virus isolates that differ as to genotype. The CMV has linear double-stranded DNA that is enclosed by a capsid. The tegument proteins are located between the capsid and the shell in which the virus-coded glycoproteins are stored.
HCMV is found throughout the world and is one of the most common viral pathogens of congenital infections. Seroprevalence depends on the age and socio-economic factors of the studied population. Factors such as the number of sexual partners, contact in caring for small children, and hygienic conditions play a role. In particular, toddlers aged 2 and younger can secrete larger quantities of the virus after a congenital and postnatal CMV infection. The virus can be found in tears, saliva, urine, genital secretions, breast milk, and blood. The virus can be transmitted on contact with infectious bodily fluids, e.g., through breastfeeding, kissing, sexual contact, as well as from blood products and organ transplants.
In most cases, immunocompetent individuals with a CMV infection have no or nonspecific symptoms (such as flu-like respiratory symptoms, fatigue, fever, and cough). The majority (approx. 75 %) of women infected with CMV during pregnancy have no symptoms. In newborns and individuals with congenital or acquired immune deficiencies or in persons undergoing immunosuppressive therapy, the infection can cause complications and damage numerous organ systems. In particular, the lungs, liver, intestines, and eyes are at risk. An infection in the lungs can cause pneumonia. In the eyes, the retina can become infected (retinitis) and lead to blindness.
|Test format||Real-time PCR with 100 reactions|
|Shelf life||18 months from production|
|Sensitivity||≥ 10 DNA copies / reaction|