The test is intended for the diagnosis of CMV-caused or CMV-associated diseases such as infectious mononucleosis (IM), CMV syndrome, hepatitis in infants, intersticial pnemonia and active CMV infection in immunocompromised patients. The kit could be used for a complex characterisation of neurological or internal disorders and to test CMV seropositivity of blood and organ transplantation donors or acceptors. This examination can be supplemented with determination of IgM and IgG anti-CMV antibodies, eventually with IgG anti-CMV avidity test and with quantification of CMV-specific IgG in serum and cerobrospinal fluid.
Contents of Kit
1. ELISA break-away strips (clear)
2. Positive control serum
3. Negative control serum
4. Anti-human IgA antibodies
5. Wash Buffer 10X
6. Dilution buffer (DB)
7. Chromogenic substrate (TMB substrate)
8. Stop solution
Store the kit reagents at 2-8°C. For longer period make aliquots and keep them at -20°C. Avoid repeated thawing and freezing. For more detailed information, please download the following document on our website
The intraassay variability (within the test) and the interassay variability (between tests) were performed with samples of variable absorbance values.
Assessment of diagnostic effectivity was performed using comparative testing of 90 CMV IgA negative and 58 CMV IgA-positive serum samples on ELISA and two alternative commercial IVD kits. Diagnostic sensitivity of the test was 100% and the specificity 96.29%.
Human cytomegalovirus is a species of virus that belongs to the viral family known as Herpesviridae or herpesviruses. It is typically abbreviated as HCMV and is alternatively known as human herpesvirus-5 (HHV-5). Within Herpesviridae, HCMV belongs to the Betaherpesvirinae subfamily, which also includes cytomegaloviruses from other mammals. Although they may be found throughout the body, HCMV infections are frequently associated with the salivary glands. HCMV infection is typically unnoticed in healthy people, but can be lifethreatening for the immunocompromised, such as HIVinfected persons, organ transplant recipients, or new born infants. After infection, HCMV has an ability to remain latent within the body over long periods. HCMV is found throughout all geographic locations and socioeconomic groups, and infects between 50% and 80% of adults in the United States (40% worldwide) as indicated by the presence of antibodies in much of the general population.Seroprevalence is agedependent: 58.9% of individuals aged 6 and older are infected with CMV while 90.8% of individuals aged 80 and older are positive for HCMV. HCMV is also the virus most frequently transmitted to a developing fetus. HCMV infection is more widespread in developing countries and in communities with lower socioeconomic status and represents the most significant viral cause of birth defects in industrialized countries. CMV "seems to have a large impact on immune parameters in later life and may contribute to increased morbidity and eventual mortality.
Reconstitution And Storage
Store the kit and the kit reagents at 2 - 10°C, in a dry place and protected from the light. Store unused strips in the sealable pouch and keep the desiccant inside. Store serum samples at 2 - 10°C up to one week. For longer period make aliquots and keep them at -20°C. Avoid repeated thawing and freezing. Do not store diluted samples. Always prepare fresh. Kits are shipped in cooling bags, the transport time of 72 hours have no influence on expiration. If you find damage at any part of the kit, please inform the manufacturer immediately. Expiration date is indicated at the ELISA kit label and at all reagent labels.