Dextramer® CMV Kit - In Vitro Diagnostics

Reducing Risks of CMV Infection in Post-transplant Patients

 

Identify Patients at Risk of CMV Infection

Transplant patients are particularly susceptible to high morbidity and mortality from cytomegalovirus (CMV) infection due to suppression of cell-mediated immunity following transplant.

With worldwide infection incidences of 60 to 80%, carefully monitoring post-transplant immune reconstitution of CMV-specific CD8+ T cells is essential for appropriate prophylactic or preemptive treatment1 while balancing the costs and potential toxicity (e.g., nephrotoxicity, peripheral blood cytopenia) associated with antiviral drugs.

Identify Patients at Risk of CMV Infection

Model for CMV-specific T-cell immune monitoring in two patients post transplantation. Dashed line indicates threshold for recovery of CMV T cell immunity.

Refined CMV Management

 

Delayed recovery of CMV-specific T cells is associated with recurrent CMV infection and disease2-5. Several clinical trials have demonstrated the value of quantifying CMV-specific CD8+ T cells as a predictor of immune resistance to CMV after hematopoietic stem cell transplantation (HSCT).

Such a tool is especially useful to avoid unnecessary antiviral treatment of patients with a viral load who would never progress to CMV disease because they have sufficient T-cell immunity to effectively control the virus.

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Immudex Dextramer CMV Kit

 

The Dextramer® CMV Kit (IVD) is designed to enumerate CMV-specific CD8+ T cells in whole blood by flow cytometry6. In fact, the Dextramer® CMV Kit (IVD) is indicated in conjunction with other laboratory and clinical findings to assess CMV-specific immune status and risk of CMV reactivation in adult HSCT recipients following immunosuppression7–8.

The Dextramer® CMV Kit (IVD) cannot be used for measuring CMV infection or disease.

Read the Study

Order Dextramer® CMV Kit (IVD)

Dextramer® CMV Kit (IVD) is available for in vitro diagnostic use in the EU and the US.
Order a kit by sending an email to ordering@immudex.com specifying the appropriate catalog number.

Cat. No Content Regulatory Status Package Insert

CX01

CMV-specific Dextramer® reagents: 
HLA-A*0101/VTEHDTLLY
HLA-A*0201/NLVPMVATV
HLA-A*0301/KLGGALQAK 
HLA-A*2402/QYDPVAALF
HLA-B*0702/RPHERNGFTVL
HLA-B*0702/TPRVTGGGAM 
HLA-B*0801/ELRRKMMYM
HLA-B*3501/IPSINVHHY 

Negative control Dextramer® reagent

For in vitro diagnostic use in EU

Link

CX02

CMV-specific Dextramer® reagents: 
HLA-A*0101/VTEHDTLLY,
HLA-A*0201/NLVPMVATV
HLA-B*0702/TPRVTGGGAM 
HLA-B*0801/ELRRKMMYM
HLA-B*3501/IPSINVHHY

Negative control Dextramer® reagent

Antibodies: Anti-CD8, Anti-CD3, Anti-CD4

For in vitro diagnostics use in US*

Link

* K153538 510(k) premarket notification. 

References

1. Badshah C. et al. . NEJM. 2017; 1-12. Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation.

2. Cwynarski K, et al. Direct visualization of cytomegalovirus-specific T cell reconstitution after allogeneic stem cell transplantation. Blood. 2001;97(5):1232-40.

3. Gratama JW, et al. Immune monitoring with iTAg MHC Tetramers for prediction of recurrent or persistent cytomegalovirus infection or disease in allogeneic hematopoietic stem cell transplant recipients: a prospective multicenter study. Blood. 2010;116(10):1655-62.

4. Gratama JW, et al. Tetramer-based quantification of cytomegalovirus (CMV)-specific CD8+ T lymphocytes in T-cell depleted stem cell grafts and after transplantation may identify patients at risk of progressive CMV infection. Blood. 2001;98(5): 1358-64.

5. Borcher et al. Sequential anti-cytomegalovirus response monitoring may allow prediction of cytomegalovirus reactivation after allogeneic stem cell transplantation. PLoS One. 2012;7(12)

6. Tario J, et al. Dextramer Reagents are Effective Tools for Quantifying CMV Antigen-Specific T Cells from Peripheral Blood Samples. Cytometry B Clin Cytom. 2014;
88(1): 6–20.

7. TF1000.07 Dextramer CMV Kit Package Insert US (IVD), Immudex.

8. TF1010.07 Dextramer CMV Kit Package Insert EU (CE-IVD), Immudex.