[의학신문·일간보사=오인규 기자] Roche Diagnostics Korea (CEO Kit Tang) recently announced that cobas EBV and cobas BKV, tests for virus and infection monitoring of organ transplant patients, have been approved by the Ministry of Food and Drug Safety as in vitro diagnostic medical devices. announced on the 25th. All of these tests are available on the cobas 6800 and cobas 8800 systems, which are high-capacity automated molecular testing equipment.
With this, Roche Diagnostics Korea released EBV and BKV tests following CMV, completing Roche Diagnostics’ transplant marker portfolio. can
These tests provide results according to WHO international standards, allowing for follow-up of results, improving the concordance rate of results among laboratories and hospitals.
In the case of organ transplant patients, immunosuppressants are taken 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 BK viruses 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-transplant lymphocyte proliferative disorder (PTLD). The risk of PTLD is highest during the first year after transplantation, during which more than 90% of PTLDs are related to EBV.
Therefore, 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 the BK virus in organ transplant patients, and is tested using human EDTA plasma and urine.
Periodic monitoring of the BK virus 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.
CEO Kit Tang said, “With the development of PCR over the past 30 years, Roche Diagnostics has provided molecular diagnostic solutions in various fields such as hepatitis, AIDS, transplantation, women’s health, oncology, genomics and microbiology. We will do our best to provide consistent and reliable results for infection control and treatment monitoring, as well as contribute to personalized treatment and management for patients.”