Human CMV IgG ELISA Kit

Sample

immunocompromised patients

Species Reactivity

Human

Detection Method

sELISA

Intended Use

The test is intended for the diagnosis of CMV-caused or CMV-associated diseases such as infectious mononucleosis (IM), CMV syndrome, acute and chronic active CMV infection in immunocompromised patients. The kit could be used for a complex characterisation of chronic fatigue syndrom and to test CMV seropositivity of blood and organ transplantation donors and acceptors.

Contents of Kit

1. ELISA break-away strips (clear)
2. Calibrator
3. Positive control serum
4. Negative control serum
5. Anti-human IgG antibodies
6. Wash Buffer 10X
7. Dilution buffer (DB)
8. Chromogenic substrate
9. Stop solution

Storage

1. Store the kit and the kit reagents at +2 to +10°C, in a dry place and protected from the light.
2. Store unused strips in the sealable pouch and keep the desiccant inside.
3. Store serum samples at +2 to +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.

Precision

The intraassay variability (within the test) and the interassay variability (between tests) were performed with samples of variable absorbance values. The values measured for this lot of the kit is stated in the Quality control certificate.

Sensitivity

Diagnostic sensitivity of the test is 99,8%.
Diagnostic sensitivity was determined by a multicentric evaluation study of this test. Serum samples of 544 CMV-IgG negative and 1101 CMV-IgG positive people were tested by the kit and the results were confirmed by other commercially available diagnostic tests.

General Description

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.