Regulatory status: For research use only, not for use in diagnostic procedures.

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Species Reactivity
Intended Use
Cytomegalovirus Antibody (CMV) ELISA IgM Assay system is an enzyme-linked immunosorbent assay (ELISA) designed for the presumptive qualitative detection of IgM antibody to CMV in human serum and for the presumptive diagnosis of acute, recent, or reactive CMV infection. To adequately assess the patient's serological status, testing should be performed in conjunction with any of the other traditional CMV diagnostic technologies.
Contents of Kit
1. Coated Microtiter: 12 x 8 wells
2. Wash buffer(40X): 20 mL
3. Specimens buffer: 11 mL
4. Substrate A: 7 mL
5. Substrate B: 7 mL
6. HRP Conjugate: 6.5 mL
7. Stop Solution: 6.0 mL
8. Negative Control: 2.0 mL
9. Positive Control: 2.0 mL
Performance Characteristics
Clinical evaluation was conducted comparing the results obtained using Cytomegalovirus Antibody ELISA IgM Assay to a predicate device. The study included 163 serum samples from Russia, Ukraine, Togo, United States, and Northern Europe. 77 samples were identified as negative and 86 samples were identified as positive.
Out of the 77 negative samples, 57 samples were retrived from paitents who had previously been CMV inoculated.

The results yielded a Specificity of 100% and a Sensitivity of 89.5%.
General Description
Cytomegalovirus (CMV) is a DNA virus herpes virus group. Widely distributed, other animals can be infected, causing the genitourinary system, central nervous system and liver disorders of various systems based infections, from mild asymptomatic infection until the serious defects or death. Cytomegalovirus also known as virus inclusion body cells, swelling of the infected cells and nuclear inclusion bodies with huge, hence the name.
CMV has the typical form of herpes virus, the HSV DNA structure and similar, but 5% larger than the HSV. The virus on the host or cultured cells with a high degree of species specificity, human cytomegalovirus (HCMV) can infect humans, and the proliferation of cells in the human fiber. The proliferation of the virus in cell culture slow replication cycle length, first isolated and cultured 30 to 40 days appear to be cenotaphic, characterized by rounded cell swelling, nuclear becomes larger, the nucleus around which a round there, "halo" of large addicted acid inclusions. CMV infection can affect the host organism in various organs and systems, but few opportunities for serious disease, target organ damage and with the children's age. Central nervous system damage (such as microcephaly, mental retardation, etc.) and congenital malformations were mainly seen in congenital infections; hepatitis, pneumonia can also be seen in infants and young children during infection. Therefore, infection after birth has been found in children with central nervous system damage and congenital malformations, be classified as caused by CMV infection is unscientific.
Of symptomatic CMV infection such as pneumonia, hepatitis diagnosis, rely solely on serology or urine, blood, positive results in the virological examination irregularities. The performance of these test results because the body can only exist with CMV or copied, but no orientation significance. Such as from lung disease, liver tissue in situ testing positive then, for the reliable, but the implementation difficulties. Thus, children with pneumonia should be taken to replace the lower respiratory tract secretions can cause the same disease or exclude other causes and pathogens, and strive to diagnose and reliable.


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Kawano, Y; Mizuta, K; et al. Risk Factors of Cytomegalovirus Infection After Pediatric Liver Transplantation. TRANSPLANTATION PROCEEDINGS 46:3543-3547(2014).
Cukjati, M; Rajic, V; et al. Guidelines for the prevention of CMV transmisson by transfusion of blood components. ZDRAVNISKI VESTNIK-SLOVENIAN MEDICAL JOURNAL 82:367-377(2013).

Bialas, Kristy M., et al. "Maternal Antibody Responses and Nonprimary Congenital Cytomegalovirus Infection of HIV-1–Exposed Infants." Journal of Infectious Diseases 214.12 (2016): 1916-1923.

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