Roche Diagnostics Korea (CEO Kit Tang) recently announced that it has been approved by the Ministry of Food and Drug Safety for cobas EBV2 and cobas BKV3, tests for virus and infection monitoring of organ transplant patients 24 work said All of these tests can be used on the cobas 6800 and cobas 8,800 systems, which are high-capacity automated molecular testing equipment.
Following CMV4, Roche Diagnostics Korea released EBV and BKV tests and completed the transplant marker portfolio of Roche Diagnostics. done. By providing results according to WHO international standards, these tests allow for follow-up of results, improving the concordance rates of results across laboratories and hospitals.
Organ transplant patients take immunosuppressants to reduce transplant rejection, which reduces immune system function and increases the risk of viral and bacterial infections compared to healthy individuals. CMV, EBV, and BKV are the most common post-transplant infections in organ transplant patients, and it is very important to monitor patients with standardized quantitative tests.
The cobas EBV (cobas EBV) test is used to indicate the need for a potential treatment change in patients being monitored for Epstein-Barr Virus (EBV) and to evaluate the viral response to treatment. EBV is a member of the herpesvirus family and can cause lymphoproliferative disorders in people with congenital or acquired immunodeficiency, including transplant patients and people with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS).
The most serious form of EBV-associated disease is post-transplantation lymphocyte proliferative disorder (PTLD). The risk of PTLD is highest during the first year after transplantation, and more than 90% of PTLDs during this period are associated with EBV. For that reason, early detection of primary EBV infection and monitoring of DNA levels are necessary to prevent progression to EBV-related diseases. In particular, regular EBV monitoring using DNA quantitative testing is recommended for transplant recipients who are EBV-negative among high-risk transplant patients.
Another transplant marker, the cobas BKV test, can help diagnose and manage BKV in organ transplant patients, and is tested using human EDTA plasma and urine. Regular monitoring of BKV for up to 5 years after transplantation is recommended for kidney transplant patients because it can cause serious clinical diseases such as ureteral stenosis, hematopoietic stem cell transplantation, and hemorrhagic cystitis in immunocompromised persons, including transplant patients.
Roche Diagnostics Korea CEO Kit Tang said, “Roche Diagnostics is a pioneer in the field of molecular diagnostics and has provided molecular diagnostic solutions for various fields such as hepatitis, AIDS, transplantation, women’s health, oncology, genomics and microbiology along with the development of PCR over the past 30 years. “Through the launch of Kovas EBV and BKV, we will do our best to provide consistent and reliable results for infection control and treatment monitoring of transplant patients, as well as contribute to customized treatment and management for patients in the future.” .