產品名稱：Rubella IgG ELISA
產    地：Demeditec 
產品貨號：DERUB01
產品規(guī)格：96 Tests
產品說明：
Special remarks:
1. Intended Use
The DEMEDITEC Rubella IgG Antibody ELISA Test Kit has been designed for the detection and the quantitative determination of specific IgG antibodies against Rubella in serum and plasma. Further applications in other body fluids are possible and can be requested from the Technical Service of DEMEDITEC.
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
Rubella infection belongs to the classical children´s diseases with a life-long immunity, and the virus is spread worldwide endemically. In non-vaccinated populations, 80-90% of the infections occur during the childhood.
In spite of the rubella vaccination, introduced in 1974, in Germany there continue to appear connatal diseases.
The causative agent is a genetically stable RNA virus, which belongs to the genus rubivirus within the family of togaviridae. Human beings are the only known natural hosts for the rubella virus. The transmission occurs via droplet infection, with an incubation time of 14-23 days.
Clinically the disease manifests itself like a light flu infection. The nucal and retroaurical lymph nodes are swollen, and a moderate enlargement of the spleen is observed. A short and medium raise of temperature appears together with a rather slight sensation of illness. Rubella is overcome easily with insignificant and light symptoms during the childhood, however more attention is required in the case of the infection of nonimmunized pregnant women, because of the possible malformations of the foetus, which can be generated.
As the infection can be transmitted via the placenta, the developing foetus can suffer severe damages, the frequency and gravity of which is dependent on the moment of infection during pregnancy. A rubella infection during the 1st till 4th month can lead to a spontaneous abortion or premature birth. Since a specific causal therapy does not exist, the secondary signs like fever, arthritis or arthralgies are treated symptomatically.
The clinical differential diagnosis is problematic, because similar exanthems and feverish illnesses appear also in the course of other children´s diseases like measles, scarlet and parvovirusitis.
The following laboratory methods are available: hemagglutination inhibition test (HIT), hemolysis-in-gel test or ELISA. The detection of virus-specific IgM antibodies is important for the assessment of fresh infections, and the IgG test is used for the determination of immunity. In the case of severe connatal infections, the isolation of the rubella virus from pharyngeal lavage, urine and other secretions can also be performed.
3. Principle of the Test
The DEMEDITEC Rubella IgG antibody test kit is based on the principle of the enzyme immunoassay (EIA).
Rubella 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 Rubella 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 antihuman-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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