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[ { "Name": "Storage Conditions (Product)", "Value": "Upon receipt and when not in use, store at 2-8°C. Do not freeze.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Background Information", "Value": "Human cytomegalovirus (CMV) is a ß-herpesvirus (human herpesvirus 5) that causes widespread persistent infection. CMV continues to be an important opportunistic pathogen in immunocompromised patients. It is estimated that 30% of transplant recipients experience CMV disease.¹ The range of organ involvement in post-transplant CMV disease is wide; hepatitis occurs in 40% of liver transplant recipients², and pneumonitis is more frequently seen in heart and heart-lung transplant patients.³ Other organs that are commonly affected are the gastrointestinal tract and the peripheral and central nervous systems. Histologic diagnosis of CMV in fixed tissues usually rests on identifying characteristic cytopathic effects including intranuclear inclusions, cytoplasmic inclusions, or both, especially in the endothelial cells. However, histologic examination lacks sensitivity, and in some cases atypical cytopathic features can be confused with reactive or degenerative changes.⁴ Additionally, up to 38% of patients with gastrointestinal CMV disease fail to demonstrate any inclusions.⁵ In these cases, IHC using monoclonal antibodies against early and late CMV antigens allows the detection of CMV antigens in the nucleus and cytoplasm of infected cells. In addition, IHC may allow detection of CMV antigens early in the course of the disease when cytopathic changes have not yet developed.⁶ Various CMV antigens can serve as IHC targets for the detection of CMV infection. During productive, lytic CMV infection, the viral genes, encoding these antigens, are expressed in a coordinated and temporal fashion. The first viral genes expressed at 3-12 hours post-infection are the immediateearly (IE) genes, which control viral and cellular gene expression to optimize the host environment for the production of viral DNA.7 IE gene expression is followed by viral early (E) gene transcription, or delayed early or intermediate early genes, usually expressed at 12-24 hours postinfection. The E genes encode for proteins that are involved in viral DNA replication. Finally, E gene expression is followed by the transcription of viral late genes. The late genes encode for virus structural proteins.⁷ The sensitivity of IHC for detecting CMV infection ranges from 78% to 93%.^4-5 The sensitivity of IHC is better than light microscopic identification of viral inclusions and compares favorably with culture and in situ hybridization.^6-9 Additionally, immunohistochemical assays can be completed faster than the shell vial culture technique, allowing for rapid results that are important for early anti-CMV therapy.¹⁰ Immunohistochemistry has been used to detect CMV infection in patients with steroid refractory ulcerative colitis, and the routine use of IHC for the detection of CMV in the evaluation of these patients is now recommended.^11-12 CMV immunostaining has been used to detect occult CMV infection of the central nervous system in liver transplant patients who develop neurologic complications.¹³ It has also been used to demonstrate a high frequency of CMV antigens in tissues from firsttrimester abortions.¹⁴

1. de la Hoz, RE et al. Diagnosis and treatment approaches to CMV infections in adult patients. J Clin Virol 2002; 25:S1-S12.
2. Bronsther, O et al. The occurrence of cytomegalovirus hepatitis in liver transplant patients. J Med Virol 1988; 24:423-434.
3. Drummer, JS et al. Morbidity of cytomegalovirus infection in recipients of heart or heart-lung transplant who receive cyclosporine. J Infect Dis 1985; 152:1182-1191.
4. Anwar, F et al. Are there cytopathic features associated with cytomegalovirus infection predictive of resistance to antiviral therapy?. Ann Diag Pathol 1999; 3:19-22.
5. Cote, L et al. Diagnostic value of amplification of human cytomegalovirus DNA from gastrointestinal biopsies from human immunodeficiency virus-infected patients. J Clin Microbiol 1993; 31:2066-2069.
6. Sheehan, MM et al. Detection of cytomegalovirus (CMV) in HIV+ patients: comparison of cytomorphology, immunocytochemistry and in situ hybridization. Cytopathology 1998; 9:29–37.
7. Saetta, A et al. Determination of CMV placentitis: Diagnostic application of the polymerase chain reaction. Virchows Arch 1998; 432:159-162.
8. Solans, EP et al. Bronchioloalveolar lavage in the diagnosis of CMV pneumonitis in lung transplant recipients: an immunocytochemical study. Diagn Cytopath 1997; 16:350-352.
9. Colina, F et al. Histological diagnosis of cytomegalovirus hepatitis in liver allografts. J Clin Pathol 1995; 48:351-357.
10. Rimsza, LM et al. Rapid automated combined in situ hybridization and immunohistochemistry for sensitive detection of cytomegalovirus in paraffin-embedded tissue biopsies. Am J Clin Pathol 1996; 106:544-548.
11. Kandiel, A et al. Cytomegalovirus colitis complicating inflammatory bowel disease. Am J Gastroenterol 2006; 101:2857-2865.
12. Kambham, N et al. Cytomegalovirus infection in steroidrefractory ulcerative colitis. A case-control study. Am J Surg Pathol 2004; 28:365-373.
13. Ribalta, T et al. Presence of occult cytomegalovirus infection in the brain after orthotopic liver transplantation. An autopsy study of 83 cases. Virchows Arch 2002; 440:166-171.
14. Cruz-Spano, L et al. Human cytomegalovirus infection and abortion: an immunohistochemical study. Med Sci Monit 2002; 8:BR230- BR235.", "Language": "en", "Country": "XG", "Code": "Background Information" }, { "Name": "Content", "Value": "One dispenser of CMV (8B1.2, 1G5.2 & 2D4.2) primary antibody contains sufficient prediluted reagent for 50 tests. The antibody is diluted in Tris Buffer, pH 7.3-7.7, with 1% BSA and <0.1% Sodium Azide.", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Intended Use", "Value": "This antibody is intended for in vitro diagnostic (IVD) use.

The Cell Marque CMV (8B1.2, 1G5.2 & 2D4.2) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods. Use of this antibody is indicated, subsequent to clinical differential diagnosis, as an aid in the identification of cytomegalovirus within the context of an antibody panel, the patient’s clinical history, and other diagnostic tests evaluated by a qualified pathologist.", "Language": "en", "Country": "XG", "Code": "Intended Use" }, { "Name": "Principle", "Value": "Anti-CMV (8B1.2, 1G5.2 & 2D4.2) may be used as the primary antibody for immunohistochemical staining of formalin-fixed, paraffinembedded tissue sections. In general, immunohistochemical staining in conjunction with a streptavidin-biotin detection system allows the visualization of antigens via the sequential application of a specific antibody (primary antibody) to the antigen, a secondary antibody (link antibody) to the primary antibody, an enzyme complex and a chromogenic substrate with interposed washing steps. Alternatively, a biotin-free detection system may be used. The enzymatic activation of the chromogen results in a visible reaction product at the antigen site. The specimen may then be counterstained and a coverslip applied. Results are interpreted using a light microscope and aid in the differential diagnosis of pathophysiological processes, which may or may not be associated with a particular antigen.

Anti-CMV (8B1.2, 1G5.2 & 2D4.2) is optimally diluted to be compatible with Ventana Roche detection kits and automated slide stainers. Each step in the staining protocol includes incubation for a precise time at a specific temperature. At the end of each incubation step, the sections are rinsed by the Ventana Roche automated slide stainer to stop the reaction and remove unbound material that would hinder the desired reaction in subsequent steps. To minimize evaporation of the aqueous reagents from the specimen-containing slide, a coverslip solution is applied in the slide stainer. For more detailed information on instrument operation, refer to the appropriate Ventana Roche automated slide stainer Operator’s Manual.", "Language": "en", "Country": "XG", "Code": "Principle" }, { "Name": "Product Purpose", "Value": "This antibody is intended for in vitro diagnostic (IVD) use.

The Cell Marque CMV (8B1.2, 1G5.2 & 2D4.2) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods. Use of this antibody is indicated, subsequent to clinical differential diagnosis, as an aid in the identification of cytomegalovirus within the context of an antibody panel, the patient’s clinical history, and other diagnostic tests evaluated by a qualified pathologist.", "Language": "en", "Country": "XG", "Code": "Product Purpose" } ] } } ] }