【Product Name】Detection Kit for Cytomegalovirus IgG antibody (enhanced chemiluminescence immunoassay)

【registration certificate number】 国械注准20173401142

       This product is used for qualitative, semi-quantitative detection of the content of Cytomegalovirus IgG antibody in human serum in vitro.

        TORCH is shorthand for Toxoplasma gondii, rubella virus, cytomegalovirus and herpes simplex virus. When the body infected with the above pathogens from different pathways, it will produce the corresponding IgM and IgG antibodies in serum. IgG test is mainly used to illustrate the history of previous infections and chronic disease, IgM is the detection of recent activities of microorganisms or chronic diseases, which can reflect the clinical symptoms accurately. This group of microbial infections have the same characteristics is that they can cause mother-infant infection. Because of changes of endocrine and decreased immunity, pregnant women are prone to primary infection, the potential virus pregnant women infected previously can easily be activated and often occur recurrent infection. The virus can infect the early fetus through the placenta or birth canal if pregnant women suffered from viremia, causing premature birth, miscarriage, stillbirth or teratogenic, besides, it also induce multiple neonatal system, multiple organ damage, and different degrees of mental retardation. Especially in the first trimester of pregnancy, the embryo is in the organogenesis stage, if fetus is infected with the virus at this time, the division and proliferation of cells or fictive cells can be disrupted. After the organism is infected, the virus can destroy the structure of the tissues and organs and form a persistent infection. After the birth, the detoxification continues and the corresponding lesions are caused. Therefore, TORCH infection affects the quality of the population and has an important relationship with eugenics.

        This kit uses microplate coated by antigen to make into solid-phase carrier. Patient sera are added to the wells of the plate, and the contained antibodies bind specifically to the antigen present in the solid-phase carrier and form an immune complex. After removing excess material, horseradish peroxidase-labeled IgG antibody was added to react with the above immune complex. The plate was washed to remove the excess conjugates, the optical signal would generate after adding substrate because of the reaction between substrate solution and HRP.

The optical signal intensity was changed correspondingly with the change of the content of IgG antibody-HRP. Therefore, the content of Cytomegalovirus IgG antibody in the sample was determined by measuring the intensity of light signal.

1. High Sensitivity: chemiluminescence immuno assay can detect the substance that radioimmunoassay, enzyme-linked immunosorbent assay and other methods can not, early diagnosis of disease is of great significance.

2. Short Detection time: the optical signal measurement time of each sample is less than a second, which is very necessary for emergency situations in medical and health work (such as rescue, blood transfusion, emergency surgery, remote treatment, etc.).

3. Excellent stability: the validity period is up to one year, which is conducive to the popularization and application.

4. Simple and fast operation: Chemiluminescence immunoassay is simple and fast, the test can be completed one hour and projects commonly used can print report one hour.

5. Fast, good security: chemiluminescence immunoassay does not involve harmful chemical composition for human, although there are also waste exclusion, no harmful pollution to the environment.

Infection of TORCH

Toxoplasma gondii (TOX): Fetal malformations induced by Toxoplasma infection in the first trimester mainly include hydrocephalus, cerebellar deformities, chorioretinitis and cerebral calcification. Blood infection can cause multiple organ necrosis of the fetus, such as hepatosplenomegaly, myocarditis and thrombocytopenia.

Rubella virus (RV): RV is mainly transmitted through the respiratory tract, infected pregnant women can make the fetus teratogenic, the virus can infect the fetus through the placenta to form a congenital infection called congenital rubella syndrome (CRS). It mainly manifest as congenital cataracts, congenital heart disease and neurological deafness, infected person has almost no effect after 20 weeks. The earlier the Rubella infection occurs during pregnancy, the more severe fetal teratogenicity.

Cytomegalovirus (CMV): It can cause intrauterine fetal growth retardation, small head, encephalitis, retinal meningitis, jaundice, hepatosplenomegaly and hemolytic anemia after infection. Neonatal mortality is high, perinatal CMV infection caused by breast milk detoxification rate was 63%.

Herpes simplex virus (HSV I, II): HSV is usually lurking in the ganglia. Physiological changes of the mother during pregnancy makes HSV activate, infection in early pregnancy would destroy the germ surface infection, leading to miscarriage. Although infection in middle-late pregnancy rarely induces teratism, it can make morbidity of fetus and newborn increased.

The treatment of TORCH test results

1. Herpes simplex virus infection

Hazards: Pregnant women infected in early pregnancy would cause miscarriage or fetal malformations. Its teratogenic effects are weaker than infections of cytomegalovirus. Common deformities are ocular deformities (such as small eyeballs, monocular, cataracts and optic atrophy), neurological deficits (such as cortical atrophy and dementia), bone and skin lesions.

Treatment: serum herpes simplex virus IgM antibody is positive, heat-clearing and detoxifying drugs (such as Banlangen) are available for inhibiting the proliferation of virus and infection control, coated with 1% gentian violet to keep the lesions dry. There is no need to terminate pregnancy generally because the fetus is less affected. In principle, cesarean section is necessary during childbirth even if the lesion has been cured, if the initial infection is less than one month, cesarean section is still appropriate.

2. Rubella infection

Hazards: If pregnant women infected rubella virus in early pregnancy, the virus can infect the fetus through the placenta, causing miscarriage, intrauterine growth retardation and congenital rubella syndrome (CRS). Congenital rubella syndrome is fetal malformation syndrome caused by rubella virus infection, including ocular deformities (such as congenital cataracts, small ocular deformity, strabismus), small head, congenital heart disease, deaf, dumb, cleft palate, short fingers, hypospadias and hemolytic anemia. The earlier the infection of rubella in pregnant women, the higher the incidence of fetal malformations and the degree of deformity is more serious.

Treatment: Rubella infection occurs in early pregnancy (serum IgM antibody showes positive) would result in high probability fetal deformity, in this case, the mother should terminate the pregnancy. If the infection occurs in the middle-late pregnancy, prenatal diagnosis should be carried out to exclude fetal infection before continuing pregnancy, the pregnant mothers also need to be cautious for medicating, they should pay attention to symptomatic treatment and avoid damage to the baby.

3. Infection of Toxoplasma

Hazards: Fetal malformations induced by Toxoplasma infection in the first trimester mainly include hydrocephalus, cerebellar deformities, chorioretinitis and cerebral calcification. Blood infection can cause multiple organ necrosis of the fetus, such as hepatosplenomegaly, myocarditis and thrombocytopenia. Asymptomatic infection can induce intrauterine growth retardation and premature delivery. Infections in the middle-late pregnancy generally do not cause fetal abnormalities.

Treatment: Toxoplasma antibody test should be accepted actively, in early pregnancy, acute infection should be treated with insect-resistant as early as possible. For mid-early pregnancy (within 24 weeks), Toxoplasma gondii antibody IgM is positive, it is best to take abortion or drug treatment to reduce the incidence of intrauterine infection.

4.Infection of cytomegalovirus 

Hazards: Infection in early pregnancy can cause miscarriage and fetal death, infection in middle-late pregnancy can cause fetal jaundice, hepatosplenomegaly, cerebellar malformations, hydrocephalus, cerebral softening, cataracts, cytomegalovirus pneumonia, congenital heart disease, cleft lip, cleft palate.

Treatment: [1] Cytomegalovirus, such as serum antibody IgM or IgG positive, indicates that the pregnant woman is infected. Pregnancy infected early generally treated with immediate termination of pregnancy or prenatal diagnosis of IgM until 16 to 20 weeks to determine whether the baby has a congenital infection. If confirmed, the mother should have a timely termination of pregnancy.

Vast majority of pregnant women infected with cytomegalovirus have sub-clinical manifestations, it generally do not need special treatment. Even intrauterine infection of cytomegalovirus was found in prenatal diagnosis, drug treatment is also not advocated because drug treatment can not change the baby's condition. Antiviral therapy should be considered only when the immune function of pregnancy is low and the symptoms of cytomegalovirus dominant infection appear (it only works for pregnant women). Ganciclovir is considered more effective drug currently. If it is already in the last trimester, allows for vaginal delivery may have been infected the baby in the womb, cytomegalovirus isolated from the cervical canal usually does not need special treatment and vaginal delivery is allowed. As neonatal urine may have cytomegalovirus, neonatus should use disposable diapers or used diapers do disinfects processing.  

Clinical laboratory, physical examination center.