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产品名称:Cytomegalo Virus (CMV) IgG

产    地:Demeditec  

产品货号:DECMV01

产品规格:96 Tests

产品说明:

Special remarks:

1. Intended Use:


The DEMEDITEC Cytomegaly IgG Antibody ELISA Test Kit has been designed for the detection and the quantitative determination of specific IgG antibodies against Cytomegalovirus in serum and plasma.

Monitoring of patients with engrafted organs as well as determination of antibodies in other body fluids were not validated and hence are within the responsibility of the user.

This assay is intended for in-vitro diagnostic use only.

Laboratory results can never be the only base of a medical report. The patient history and further tests have additionally to be taken into account.

2. General Information

Cytomegaly is caused by a viral infection, which shows an inapparent progression, however leads to serious symptoms with immune-compromised patients and newborns.

The cytomegaly virus (CMV) with a particle diameter of 100 nm (inclusive envelope the virion measures 200nm) belongs to the family of herpesviridae like Herpes 1 and Herpes 2. The transmission is effected via saliva and by long-term intimate contacts. The incubation time is 2-10 days for primary infections.

Cytomegaly appears often during the gravidity, and per year up to 5% of the pregnant women show clinical signs of the disease. In the early phase the illness frequently remains undetected, and the affected women themselves show no symptoms. When however newborns are infected (1% of the births), these show in 10% of the cases disease symptoms with late damages like retinitis, ulcera of the mucous membrane, viral pneumonia, meningitis, microencephaly, hydrocephalus and skin ulcerations. The incidence of women

capable of childbearing is estimated to be 65%, so that an assessment of the immune status before pregnancy is mandatory. After a negative result, a control check is recommended in the 20th week of gestation.

Besides the symptomatic treatment a specific therapy with phosphonoformate and ganciclovir is possible. A vaccination does not exist, so that in the case of an infection only passive CMV immunoglobulins are

administered.

Together with the differential assessment of the above mentioned symptoms, the diagnosis is performed clinically in tissue samples via the so-called “owl eyes”. The following laboratory methods are available: CF and ELISA, determination of virus nucleic acid (PCR) as well as virus isolation (cell culture). Serologically, IgG and IgM antibodies can be detected and quantitated by the ELISA technique. Also the measurement of the avidity of the IgG molecules is appropriate.

3. Principle of the Test

The DEMEDITEC Cytomegaly IgG antibody test kit is based on the principle of the enzyme immunoassay (EIA). Cytomegalovirus antigen is bound on the surface of the microtiter strips. Diluted patient serum or ready-to-use calibrators are pipetted into the wells of the microtiter plate. A binding between the IgG

antibodies of the serum and the immobilized Cytomegalovirus antigen takes place. After a one hour incubation at room temperature, the plate is rinsed with diluted wash solution, in order to remove unbound material. Then ready-to-use anti-human-IgG peroxidase conjugate is added and incubated for 30 minutes.

After a further washing step, the substrate (TMB) solution is pipetted and incubated for 20 minutes, inducing the development of a blue dye in the wells. The color development is terminated by the addition of a stop solution, which changes the color from blue to yellow. The resulting dye is measured spectrophotometrically at the wavelength of 450 nm. The concentration of the IgG antibodies is directly proportional to the intensity of the color.

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Cytomegalo Virus (CMV) IgM Demeditec DECMV03 96 Tests 1804